Eczematous dermatoses are associated with several pathogenic factors. These include disruption of epidermal barrier function, which is exemplified by an increase in transepidermal water loss (TEWL), and inflammation, the latter exhibiting a varied clinical presentation depending on the stage of cutaneous inflammation.
Eczematous dermatitis presents clinically as one of three stages, acute, subacute or chronic.1
Acute eczematous dermatitis presents with erythema, edema, and vesiculation. Subacute eczematous dermatitis also presents with erythema, a lesser degree of edema, more subtle vesiculation when present, and scaling. Lichenification is the hallmark of chronic eczematous dermatitis.
The cardinal symptom of eczematous dermatitis, regardless of the stage, is pruritus. The hallmark example of a chronic and recurrent eczematous disorder is atopic dermatitis. Other eczematous disorders that may be chronic and/or recurrent are nummular eczema, contact dermatitis, dyshidrotic eczema, and stasis dermatitis. Pharmacologic management typically involves topical corticosteroid therapy, with the potency based on the severity of clinical presentation. However, especially in cases of eczematous dermatitis that are chronic and recurrent, optimal management incorporates appropriate skin care combined with pharmacologic therapy2,3 The latter serves to mitigate the flare of eczematous dermatitis, while the former provides both adjunctive therapeutic benefit during the flare state and serves to maintain epidermal barrier function during periods of remission.
Epidermal Barrier Dysfunction
Chronic eczematous dermatoses, such as atopic dermatitis, are associated with epidermal barrier dysfunction typified by an increase in TEWL.2,3 In the case of atopic dermatitis, aberrations in the composition of the epidermal intercellular lipid membrane, such as a decrease in ceramides 1-3 and cholesterol sulfate, have also been noted (Figure 1).4
An effective skincare regimen should include properly formulated moisturizers and cleansers in order to optimize epidermal barrier repair. Using moisturizers that contain appropriate occlusive and humectant components and an appropriate combination of physiologic lipids serve to provide both immediate and sustained barrier repair properties (Figure 2).5 Pure occlusive components, such as petrolatum, provide immediate and partial barrier repair within minutes. However, the barrier repair effects of physiologic lipids are delayed over a period of hours, and are more substantive, as these lipids are first incorporated into epidermal lamellar bodies prior to secretion of the packaged lipids into the intercellular lipid membrane, which is often referred to as “the mortar” of the stratum corneum.5
Clinical evidence indicates that appropriate skin care, such as a topical corticosteroid used in combination with a gentle cleanser and moisturizer, enhances therapeutic benefit over use of a topical corticosteroid alone.2,6,7
For example, Figure 3 depicts superior clinical results in the treatment of atopic dermatitis at all study time points in participants treated twice daily with a ceramide-based cleanser (CeraVe Cleanser), a moisturizer cream (CeraVe Cream), and fluocinonide cream 0.05% (Lidex Cream), as compared to results observed with the same topical corticosteroid used with only the gentle cleanser, or without both a gentle cleanser and a moisturizer.7
Clocortolone Pivalate 0.1% Cream Data Review
Clocortolone pivalate 0.1% is a mid-potency topical corticosteroid available as an emollient cream (Cloderm Cream) approved for use in both adults and children.8 Recently, this agent has also been packaged in a 30-g metered-dose pump, allowing for more controlled and quantified delivery when applicable. Favorable efficacy and safety of clocortolone pivalate 0.1% cream has been demonstrated in studies inclusive of >2,500 patients evaluating treatment of multiple corticosteroid-responsive dermatoses in both adult and pediatric populations.8
The cutaneous bioavailability of clocortolone pivalate 0.1% cream has been evaluated in both inflamed and normal human skin through in vivo and in vitro permeation studies.9 Cutaneous drug concentrations assessed in an in vivo human skin study demonstrated 19-fold and 7-fold higher concentrations in the epidermis and dermis, respectively, in inflamed skin compared to normal skin.
Ten study participants applied 30 grams of clocortolone pivalate 0.1% cream twice daily under whole-body plastic sweatsuit occlusion worn 12 hours daily in a 21-day open trial. Evaluations and serum assays were completed 48 hours before treatment was initiated, daily for 5 days during the treatment phase, and for 5 days post-therapy. No evidence of hypothalamic-pituitary-adrenal axis suppression was observed based on serial measurements of serum 17-ketosteroid and cortisol levels.9
The clinical efficacy and safety of clocortolone pivalate 0.1% cream has been previously reviewed and is recaptured here for completeness of data presentation.8,9
Fifteen vehicle-controlled clinical trials have established the efficacy of clocortolone pivalate 0.1% cream when used to treat a variety of steroid-responsive dermatoses.8,9 Results from double-blind, vehicle-controlled trials are summarized below and in Tables 1 through 4.
Pediatric Patients
Eighty-three pediatric patients ranging in age from newborn to 15 years were treated with clocortolone pivalate 0.1% cream in an open-label trial (n=39) and in controlled clinical trials (n=44).8,9 Twenty-three patients were £9 years of age and 18 patients were £4 years of age. Disorders treated included atopic dermatitis/eczema (n=70), psoriasis (n=12) and contact dermatitis (n=1). Efficacy and safety in pediatric patients were both documented. The approved labeling with clocortolone pivalate cream 0.1% does not contain an age restriction related to use.
Facial Dermatoses
Facial use of clocortolone pivalate 0.1% cream was observed in 147 patients using treatment durations of up to 40 days in clinical trials for atopic dermatitis and seborrheic dermatitis.8,9 No cases of atrophy, hypopigmentation or striae were reported. One trial of 38 patients assessed efficacy and safety of clocortolone pivalate 0.1 % cream applied for facial dermatoses 3 times daily for 21 days.8,9 Efficacy was favorable, with 66% of patients demonstrating good to excellent response and no cases of atrophy, striae or telangiectasia were noted.
Tolerability and Safety
In combined clinical data from trials inclusive of 1,038 patients, clocortolone pivalate 0.1% cream was very well tolerated, with 96% of patients experiencing no adverse reactions. A subset assessment of 559 patients treated with clocortolone pivalate 0.1% cream experienced a local adverse reaction rate of 4.4% (25/559), characterized primarily as dryness, stinging, burning and/or itching; no systemic adverse effects have been noted.8,9
Clinical studies in multiple corticosteroid-responsive disease states, such as contact dermatitis, atopic dermatitis, seborrheic dermatitis, psoriasis vulgaris and stasis dermatitis, demonstrate that clocortolone pivalate 0.1% cream is effective and safe when used appropriately. Safety analysis also indicates no reports of cutaneous atrophy, striae or hypopigmentation in the aforementioned clinical trials, including a large subset of patients treated for facial dermatoses (n=147).8,9
In most studies with clocortolone pivalate 0.1% cream, treatment duration ranged from 14 to 28 days. In one study of 110 patients with chronic eczematous disease or psoriasis vulgaris, clocortolone pivalate 0.1% cream was used for maintenance therapy over a mean duration of 116.4, days with a conspicuous absence of adverse reactions observed. As with any therapeutic approach, chronic-intermittent use of clocortolone pivalate 0.1% cream as a maintenance treatment for chronic dermatoses necessitates use for actively present disease coupled with appropriate patient monitoring.
Clocortolone Pivalate 0.1% Cream Used in Combination with Designated Ceramide-Based Skin Care
Sixty-one subjects with mild-to-moderate atopic dermatitis were enrolled into a 4-week study evaluating the use of clocortolone pivalate 0.1% cream with and without use of a ceramide-based moisturizer (CeraVe Lotion) and ceramide-based cleanser (CeraVe Cleanser). The three study arms included participants treated in the morning and evening with either:
1. clocortolone pivalate 0.1% cream after use of a non-medicated bar cleanser
2. clocortolone pivalate 0.1% cream after use of the designated ceramide-based cleanser
3. clocortolone pivalate 0.1% cream after use of the designated ceramide-based cleanser, followed 30 minutes later by application of the ceramide-based moisturizer lotion.
A target area was identified which was required to demonstrate a severity of ≥3 on a 12-point scale, determined by combining 4-point scale assessments (0=none to 3=severe) for erythema (score of at least 1), pruritus (score of at least 1), papulation/induration, and excoriation. Subjects were assessed at 1, 2 and 4 weeks. Additional assessments included measurement of TEWL and skin hydration (corneometry), performed after subjects had been equilibrated after 30 minutes at a controlled room temperature (72° +/- 3° F) and humidity (50% relative humidity). Study results demonstrated that the use of a ceramide-based cleanser and moisturizer lotion along with clocortolone pivalate 0.1% cream twice daily provided greater efficacy (Figure 4), barrier repair (Figure 5), and skin hydration (Figure 6), than the topical corticosteroid used with a ceramide-based liquid cleanser or non-medicated bar cleanser, both without a moisturizer. Efficacy was defined as improvement in signs and symptoms of atopic dermatitis as compared to baseline (Figure 4). Improvement in barrier repair was defined as decrease in TEWL (Figure 5). Increase in skin moisture content (hydration) was substantiated based on an increase in corneometry scores (Figure 6). Additionally, results in all three parameters achieved in the study arm using clocortolone pivalate 0.1% cream after the ceramide-based liquid cleanser without use of a moisturizer were superior to those observed with this same topical corticosteroid used after the non-medicated bar cleanser without use of a moisturizer. However, the addition of a ceramide-based moisturizer provided the greatest levels of efficacy, barrier repair and skin hydration. These results support data from previous studies that encouraged the use of a gentle cleanser and moisturizer along with topical corticosteroid therapy in order to optimize the therapeutic outcome when treating eczematous dermatoses such as atopic dermatitis.2
Points to Remember
Chronic and recurrent eczematous dermatoses, such as atopic dermatitis, are commonly encountered in clinical practice. Epidermal barrier dysfunction is an integral pathogenic component of eczematous dermatitis, and has been most definitively characterized in atopic dermatitis. When treating these conditions, remember that:
• Optimal therapy of eczematous dermatoses warrants use of an appropriate skincare regimen.
• Incorporation of proper skin care into the overall management plan enhances the benefit of topical corticosteroid therapy.
• Ceramide-based cleansers and moisturizers have been shown to be of marked adjunctive therapeutic benefit when used in combination with topical corticosteroid therapy. Clocortolone pivalate 0.1% cream is a mid-potency topical corticosteroid which is well-established for treatment of eczematous dermatoses and other corticosteroid-responsive disorders based on multiple clinical trials and widespread clinical experience.
Eczematous dermatoses are associated with several pathogenic factors. These include disruption of epidermal barrier function, which is exemplified by an increase in transepidermal water loss (TEWL), and inflammation, the latter exhibiting a varied clinical presentation depending on the stage of cutaneous inflammation.
Eczematous dermatitis presents clinically as one of three stages, acute, subacute or chronic.1
Acute eczematous dermatitis presents with erythema, edema, and vesiculation. Subacute eczematous dermatitis also presents with erythema, a lesser degree of edema, more subtle vesiculation when present, and scaling. Lichenification is the hallmark of chronic eczematous dermatitis.
The cardinal symptom of eczematous dermatitis, regardless of the stage, is pruritus. The hallmark example of a chronic and recurrent eczematous disorder is atopic dermatitis. Other eczematous disorders that may be chronic and/or recurrent are nummular eczema, contact dermatitis, dyshidrotic eczema, and stasis dermatitis. Pharmacologic management typically involves topical corticosteroid therapy, with the potency based on the severity of clinical presentation. However, especially in cases of eczematous dermatitis that are chronic and recurrent, optimal management incorporates appropriate skin care combined with pharmacologic therapy2,3 The latter serves to mitigate the flare of eczematous dermatitis, while the former provides both adjunctive therapeutic benefit during the flare state and serves to maintain epidermal barrier function during periods of remission.
Epidermal Barrier Dysfunction
Chronic eczematous dermatoses, such as atopic dermatitis, are associated with epidermal barrier dysfunction typified by an increase in TEWL.2,3 In the case of atopic dermatitis, aberrations in the composition of the epidermal intercellular lipid membrane, such as a decrease in ceramides 1-3 and cholesterol sulfate, have also been noted (Figure 1).4
An effective skincare regimen should include properly formulated moisturizers and cleansers in order to optimize epidermal barrier repair. Using moisturizers that contain appropriate occlusive and humectant components and an appropriate combination of physiologic lipids serve to provide both immediate and sustained barrier repair properties (Figure 2).5 Pure occlusive components, such as petrolatum, provide immediate and partial barrier repair within minutes. However, the barrier repair effects of physiologic lipids are delayed over a period of hours, and are more substantive, as these lipids are first incorporated into epidermal lamellar bodies prior to secretion of the packaged lipids into the intercellular lipid membrane, which is often referred to as “the mortar” of the stratum corneum.5
Clinical evidence indicates that appropriate skin care, such as a topical corticosteroid used in combination with a gentle cleanser and moisturizer, enhances therapeutic benefit over use of a topical corticosteroid alone.2,6,7
For example, Figure 3 depicts superior clinical results in the treatment of atopic dermatitis at all study time points in participants treated twice daily with a ceramide-based cleanser (CeraVe Cleanser), a moisturizer cream (CeraVe Cream), and fluocinonide cream 0.05% (Lidex Cream), as compared to results observed with the same topical corticosteroid used with only the gentle cleanser, or without both a gentle cleanser and a moisturizer.7
Clocortolone Pivalate 0.1% Cream Data Review
Clocortolone pivalate 0.1% is a mid-potency topical corticosteroid available as an emollient cream (Cloderm Cream) approved for use in both adults and children.8 Recently, this agent has also been packaged in a 30-g metered-dose pump, allowing for more controlled and quantified delivery when applicable. Favorable efficacy and safety of clocortolone pivalate 0.1% cream has been demonstrated in studies inclusive of >2,500 patients evaluating treatment of multiple corticosteroid-responsive dermatoses in both adult and pediatric populations.8
The cutaneous bioavailability of clocortolone pivalate 0.1% cream has been evaluated in both inflamed and normal human skin through in vivo and in vitro permeation studies.9 Cutaneous drug concentrations assessed in an in vivo human skin study demonstrated 19-fold and 7-fold higher concentrations in the epidermis and dermis, respectively, in inflamed skin compared to normal skin.
Ten study participants applied 30 grams of clocortolone pivalate 0.1% cream twice daily under whole-body plastic sweatsuit occlusion worn 12 hours daily in a 21-day open trial. Evaluations and serum assays were completed 48 hours before treatment was initiated, daily for 5 days during the treatment phase, and for 5 days post-therapy. No evidence of hypothalamic-pituitary-adrenal axis suppression was observed based on serial measurements of serum 17-ketosteroid and cortisol levels.9
The clinical efficacy and safety of clocortolone pivalate 0.1% cream has been previously reviewed and is recaptured here for completeness of data presentation.8,9
Fifteen vehicle-controlled clinical trials have established the efficacy of clocortolone pivalate 0.1% cream when used to treat a variety of steroid-responsive dermatoses.8,9 Results from double-blind, vehicle-controlled trials are summarized below and in Tables 1 through 4.
Pediatric Patients
Eighty-three pediatric patients ranging in age from newborn to 15 years were treated with clocortolone pivalate 0.1% cream in an open-label trial (n=39) and in controlled clinical trials (n=44).8,9 Twenty-three patients were £9 years of age and 18 patients were £4 years of age. Disorders treated included atopic dermatitis/eczema (n=70), psoriasis (n=12) and contact dermatitis (n=1). Efficacy and safety in pediatric patients were both documented. The approved labeling with clocortolone pivalate cream 0.1% does not contain an age restriction related to use.
Facial Dermatoses
Facial use of clocortolone pivalate 0.1% cream was observed in 147 patients using treatment durations of up to 40 days in clinical trials for atopic dermatitis and seborrheic dermatitis.8,9 No cases of atrophy, hypopigmentation or striae were reported. One trial of 38 patients assessed efficacy and safety of clocortolone pivalate 0.1 % cream applied for facial dermatoses 3 times daily for 21 days.8,9 Efficacy was favorable, with 66% of patients demonstrating good to excellent response and no cases of atrophy, striae or telangiectasia were noted.
Tolerability and Safety
In combined clinical data from trials inclusive of 1,038 patients, clocortolone pivalate 0.1% cream was very well tolerated, with 96% of patients experiencing no adverse reactions. A subset assessment of 559 patients treated with clocortolone pivalate 0.1% cream experienced a local adverse reaction rate of 4.4% (25/559), characterized primarily as dryness, stinging, burning and/or itching; no systemic adverse effects have been noted.8,9
Clinical studies in multiple corticosteroid-responsive disease states, such as contact dermatitis, atopic dermatitis, seborrheic dermatitis, psoriasis vulgaris and stasis dermatitis, demonstrate that clocortolone pivalate 0.1% cream is effective and safe when used appropriately. Safety analysis also indicates no reports of cutaneous atrophy, striae or hypopigmentation in the aforementioned clinical trials, including a large subset of patients treated for facial dermatoses (n=147).8,9
In most studies with clocortolone pivalate 0.1% cream, treatment duration ranged from 14 to 28 days. In one study of 110 patients with chronic eczematous disease or psoriasis vulgaris, clocortolone pivalate 0.1% cream was used for maintenance therapy over a mean duration of 116.4, days with a conspicuous absence of adverse reactions observed. As with any therapeutic approach, chronic-intermittent use of clocortolone pivalate 0.1% cream as a maintenance treatment for chronic dermatoses necessitates use for actively present disease coupled with appropriate patient monitoring.
Clocortolone Pivalate 0.1% Cream Used in Combination with Designated Ceramide-Based Skin Care
Sixty-one subjects with mild-to-moderate atopic dermatitis were enrolled into a 4-week study evaluating the use of clocortolone pivalate 0.1% cream with and without use of a ceramide-based moisturizer (CeraVe Lotion) and ceramide-based cleanser (CeraVe Cleanser). The three study arms included participants treated in the morning and evening with either:
1. clocortolone pivalate 0.1% cream after use of a non-medicated bar cleanser
2. clocortolone pivalate 0.1% cream after use of the designated ceramide-based cleanser
3. clocortolone pivalate 0.1% cream after use of the designated ceramide-based cleanser, followed 30 minutes later by application of the ceramide-based moisturizer lotion.
A target area was identified which was required to demonstrate a severity of ≥3 on a 12-point scale, determined by combining 4-point scale assessments (0=none to 3=severe) for erythema (score of at least 1), pruritus (score of at least 1), papulation/induration, and excoriation. Subjects were assessed at 1, 2 and 4 weeks. Additional assessments included measurement of TEWL and skin hydration (corneometry), performed after subjects had been equilibrated after 30 minutes at a controlled room temperature (72° +/- 3° F) and humidity (50% relative humidity). Study results demonstrated that the use of a ceramide-based cleanser and moisturizer lotion along with clocortolone pivalate 0.1% cream twice daily provided greater efficacy (Figure 4), barrier repair (Figure 5), and skin hydration (Figure 6), than the topical corticosteroid used with a ceramide-based liquid cleanser or non-medicated bar cleanser, both without a moisturizer. Efficacy was defined as improvement in signs and symptoms of atopic dermatitis as compared to baseline (Figure 4). Improvement in barrier repair was defined as decrease in TEWL (Figure 5). Increase in skin moisture content (hydration) was substantiated based on an increase in corneometry scores (Figure 6). Additionally, results in all three parameters achieved in the study arm using clocortolone pivalate 0.1% cream after the ceramide-based liquid cleanser without use of a moisturizer were superior to those observed with this same topical corticosteroid used after the non-medicated bar cleanser without use of a moisturizer. However, the addition of a ceramide-based moisturizer provided the greatest levels of efficacy, barrier repair and skin hydration. These results support data from previous studies that encouraged the use of a gentle cleanser and moisturizer along with topical corticosteroid therapy in order to optimize the therapeutic outcome when treating eczematous dermatoses such as atopic dermatitis.2
Points to Remember
Chronic and recurrent eczematous dermatoses, such as atopic dermatitis, are commonly encountered in clinical practice. Epidermal barrier dysfunction is an integral pathogenic component of eczematous dermatitis, and has been most definitively characterized in atopic dermatitis. When treating these conditions, remember that:
• Optimal therapy of eczematous dermatoses warrants use of an appropriate skincare regimen.
• Incorporation of proper skin care into the overall management plan enhances the benefit of topical corticosteroid therapy.
• Ceramide-based cleansers and moisturizers have been shown to be of marked adjunctive therapeutic benefit when used in combination with topical corticosteroid therapy. Clocortolone pivalate 0.1% cream is a mid-potency topical corticosteroid which is well-established for treatment of eczematous dermatoses and other corticosteroid-responsive disorders based on multiple clinical trials and widespread clinical experience.
Eczematous dermatoses are associated with several pathogenic factors. These include disruption of epidermal barrier function, which is exemplified by an increase in transepidermal water loss (TEWL), and inflammation, the latter exhibiting a varied clinical presentation depending on the stage of cutaneous inflammation.
Eczematous dermatitis presents clinically as one of three stages, acute, subacute or chronic.1
Acute eczematous dermatitis presents with erythema, edema, and vesiculation. Subacute eczematous dermatitis also presents with erythema, a lesser degree of edema, more subtle vesiculation when present, and scaling. Lichenification is the hallmark of chronic eczematous dermatitis.
The cardinal symptom of eczematous dermatitis, regardless of the stage, is pruritus. The hallmark example of a chronic and recurrent eczematous disorder is atopic dermatitis. Other eczematous disorders that may be chronic and/or recurrent are nummular eczema, contact dermatitis, dyshidrotic eczema, and stasis dermatitis. Pharmacologic management typically involves topical corticosteroid therapy, with the potency based on the severity of clinical presentation. However, especially in cases of eczematous dermatitis that are chronic and recurrent, optimal management incorporates appropriate skin care combined with pharmacologic therapy2,3 The latter serves to mitigate the flare of eczematous dermatitis, while the former provides both adjunctive therapeutic benefit during the flare state and serves to maintain epidermal barrier function during periods of remission.
Epidermal Barrier Dysfunction
Chronic eczematous dermatoses, such as atopic dermatitis, are associated with epidermal barrier dysfunction typified by an increase in TEWL.2,3 In the case of atopic dermatitis, aberrations in the composition of the epidermal intercellular lipid membrane, such as a decrease in ceramides 1-3 and cholesterol sulfate, have also been noted (Figure 1).4
An effective skincare regimen should include properly formulated moisturizers and cleansers in order to optimize epidermal barrier repair. Using moisturizers that contain appropriate occlusive and humectant components and an appropriate combination of physiologic lipids serve to provide both immediate and sustained barrier repair properties (Figure 2).5 Pure occlusive components, such as petrolatum, provide immediate and partial barrier repair within minutes. However, the barrier repair effects of physiologic lipids are delayed over a period of hours, and are more substantive, as these lipids are first incorporated into epidermal lamellar bodies prior to secretion of the packaged lipids into the intercellular lipid membrane, which is often referred to as “the mortar” of the stratum corneum.5
Clinical evidence indicates that appropriate skin care, such as a topical corticosteroid used in combination with a gentle cleanser and moisturizer, enhances therapeutic benefit over use of a topical corticosteroid alone.2,6,7
For example, Figure 3 depicts superior clinical results in the treatment of atopic dermatitis at all study time points in participants treated twice daily with a ceramide-based cleanser (CeraVe Cleanser), a moisturizer cream (CeraVe Cream), and fluocinonide cream 0.05% (Lidex Cream), as compared to results observed with the same topical corticosteroid used with only the gentle cleanser, or without both a gentle cleanser and a moisturizer.7
Clocortolone Pivalate 0.1% Cream Data Review
Clocortolone pivalate 0.1% is a mid-potency topical corticosteroid available as an emollient cream (Cloderm Cream) approved for use in both adults and children.8 Recently, this agent has also been packaged in a 30-g metered-dose pump, allowing for more controlled and quantified delivery when applicable. Favorable efficacy and safety of clocortolone pivalate 0.1% cream has been demonstrated in studies inclusive of >2,500 patients evaluating treatment of multiple corticosteroid-responsive dermatoses in both adult and pediatric populations.8
The cutaneous bioavailability of clocortolone pivalate 0.1% cream has been evaluated in both inflamed and normal human skin through in vivo and in vitro permeation studies.9 Cutaneous drug concentrations assessed in an in vivo human skin study demonstrated 19-fold and 7-fold higher concentrations in the epidermis and dermis, respectively, in inflamed skin compared to normal skin.
Ten study participants applied 30 grams of clocortolone pivalate 0.1% cream twice daily under whole-body plastic sweatsuit occlusion worn 12 hours daily in a 21-day open trial. Evaluations and serum assays were completed 48 hours before treatment was initiated, daily for 5 days during the treatment phase, and for 5 days post-therapy. No evidence of hypothalamic-pituitary-adrenal axis suppression was observed based on serial measurements of serum 17-ketosteroid and cortisol levels.9
The clinical efficacy and safety of clocortolone pivalate 0.1% cream has been previously reviewed and is recaptured here for completeness of data presentation.8,9
Fifteen vehicle-controlled clinical trials have established the efficacy of clocortolone pivalate 0.1% cream when used to treat a variety of steroid-responsive dermatoses.8,9 Results from double-blind, vehicle-controlled trials are summarized below and in Tables 1 through 4.
Pediatric Patients
Eighty-three pediatric patients ranging in age from newborn to 15 years were treated with clocortolone pivalate 0.1% cream in an open-label trial (n=39) and in controlled clinical trials (n=44).8,9 Twenty-three patients were £9 years of age and 18 patients were £4 years of age. Disorders treated included atopic dermatitis/eczema (n=70), psoriasis (n=12) and contact dermatitis (n=1). Efficacy and safety in pediatric patients were both documented. The approved labeling with clocortolone pivalate cream 0.1% does not contain an age restriction related to use.
Facial Dermatoses
Facial use of clocortolone pivalate 0.1% cream was observed in 147 patients using treatment durations of up to 40 days in clinical trials for atopic dermatitis and seborrheic dermatitis.8,9 No cases of atrophy, hypopigmentation or striae were reported. One trial of 38 patients assessed efficacy and safety of clocortolone pivalate 0.1 % cream applied for facial dermatoses 3 times daily for 21 days.8,9 Efficacy was favorable, with 66% of patients demonstrating good to excellent response and no cases of atrophy, striae or telangiectasia were noted.
Tolerability and Safety
In combined clinical data from trials inclusive of 1,038 patients, clocortolone pivalate 0.1% cream was very well tolerated, with 96% of patients experiencing no adverse reactions. A subset assessment of 559 patients treated with clocortolone pivalate 0.1% cream experienced a local adverse reaction rate of 4.4% (25/559), characterized primarily as dryness, stinging, burning and/or itching; no systemic adverse effects have been noted.8,9
Clinical studies in multiple corticosteroid-responsive disease states, such as contact dermatitis, atopic dermatitis, seborrheic dermatitis, psoriasis vulgaris and stasis dermatitis, demonstrate that clocortolone pivalate 0.1% cream is effective and safe when used appropriately. Safety analysis also indicates no reports of cutaneous atrophy, striae or hypopigmentation in the aforementioned clinical trials, including a large subset of patients treated for facial dermatoses (n=147).8,9
In most studies with clocortolone pivalate 0.1% cream, treatment duration ranged from 14 to 28 days. In one study of 110 patients with chronic eczematous disease or psoriasis vulgaris, clocortolone pivalate 0.1% cream was used for maintenance therapy over a mean duration of 116.4, days with a conspicuous absence of adverse reactions observed. As with any therapeutic approach, chronic-intermittent use of clocortolone pivalate 0.1% cream as a maintenance treatment for chronic dermatoses necessitates use for actively present disease coupled with appropriate patient monitoring.
Clocortolone Pivalate 0.1% Cream Used in Combination with Designated Ceramide-Based Skin Care
Sixty-one subjects with mild-to-moderate atopic dermatitis were enrolled into a 4-week study evaluating the use of clocortolone pivalate 0.1% cream with and without use of a ceramide-based moisturizer (CeraVe Lotion) and ceramide-based cleanser (CeraVe Cleanser). The three study arms included participants treated in the morning and evening with either:
1. clocortolone pivalate 0.1% cream after use of a non-medicated bar cleanser
2. clocortolone pivalate 0.1% cream after use of the designated ceramide-based cleanser
3. clocortolone pivalate 0.1% cream after use of the designated ceramide-based cleanser, followed 30 minutes later by application of the ceramide-based moisturizer lotion.
A target area was identified which was required to demonstrate a severity of ≥3 on a 12-point scale, determined by combining 4-point scale assessments (0=none to 3=severe) for erythema (score of at least 1), pruritus (score of at least 1), papulation/induration, and excoriation. Subjects were assessed at 1, 2 and 4 weeks. Additional assessments included measurement of TEWL and skin hydration (corneometry), performed after subjects had been equilibrated after 30 minutes at a controlled room temperature (72° +/- 3° F) and humidity (50% relative humidity). Study results demonstrated that the use of a ceramide-based cleanser and moisturizer lotion along with clocortolone pivalate 0.1% cream twice daily provided greater efficacy (Figure 4), barrier repair (Figure 5), and skin hydration (Figure 6), than the topical corticosteroid used with a ceramide-based liquid cleanser or non-medicated bar cleanser, both without a moisturizer. Efficacy was defined as improvement in signs and symptoms of atopic dermatitis as compared to baseline (Figure 4). Improvement in barrier repair was defined as decrease in TEWL (Figure 5). Increase in skin moisture content (hydration) was substantiated based on an increase in corneometry scores (Figure 6). Additionally, results in all three parameters achieved in the study arm using clocortolone pivalate 0.1% cream after the ceramide-based liquid cleanser without use of a moisturizer were superior to those observed with this same topical corticosteroid used after the non-medicated bar cleanser without use of a moisturizer. However, the addition of a ceramide-based moisturizer provided the greatest levels of efficacy, barrier repair and skin hydration. These results support data from previous studies that encouraged the use of a gentle cleanser and moisturizer along with topical corticosteroid therapy in order to optimize the therapeutic outcome when treating eczematous dermatoses such as atopic dermatitis.2
Points to Remember
Chronic and recurrent eczematous dermatoses, such as atopic dermatitis, are commonly encountered in clinical practice. Epidermal barrier dysfunction is an integral pathogenic component of eczematous dermatitis, and has been most definitively characterized in atopic dermatitis. When treating these conditions, remember that:
• Optimal therapy of eczematous dermatoses warrants use of an appropriate skincare regimen.
• Incorporation of proper skin care into the overall management plan enhances the benefit of topical corticosteroid therapy.
• Ceramide-based cleansers and moisturizers have been shown to be of marked adjunctive therapeutic benefit when used in combination with topical corticosteroid therapy. Clocortolone pivalate 0.1% cream is a mid-potency topical corticosteroid which is well-established for treatment of eczematous dermatoses and other corticosteroid-responsive disorders based on multiple clinical trials and widespread clinical experience.
