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Topical Gel for Treatment of Dermatoses

March 2017

Sebuderm Topical Gel from IntraDerm Pharmaceuticals is now available. The prescription nonsteroidal gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain in individuals with various types of dermatoses, including seborrhea and seborrheic dermatitis.

Considered a chronic form of eczema, seborrheic dermatitis can present on the body where there are many sebaceous glands. Although the exact cause is unknown, genes and hormones may play a role. Triggers for seborrheic dermatitis include stress, hormonal changes or illness, harsh detergents, solvents, chemicals and soaps, and cold dry weather, according to the National Eczema Association.

Sebuderm Topical Gel with Microcyn Technology is designed to target areas of the body where seborrheic dermatitis is present such as the scalp, beard area, behind ears, chest, and nasal-labial. The gel, which contains stabilized hypochlorous acid, is a nonoily, pH neutral gel dressing.

The gel should be applied to the affected area 2 to 3 times a day or as directed by a health care provider. For skin areas, apply the gel to the affected area and gently rub in. Repeat as needed to achieve a visible layer of the gel to ensure the affected area is covered. For scalp areas, part the hair and apply directly onto the affected area and rub in and spread over the affected area. Repeat as needed to cover the affected area. The gel should dry in 3 to 5 minutes, according to the product’s prescribing information.

Sebuderm Topical Gel has been shown to improve the appearance and symptoms of facial and scalp seborrheic dermatitis. The Dermatologist Product Spotlight provides a summary of the efficacy and tolerability study in individuals with seborrheic dermatitis treated with Sebuderm Topical Gel.

Efficacy and Tolerability Study
Draelos Z.  An evaluation of oculus SebuDerm–microcyn based gel on mild to moderate facial and scalp seborrheic dermatitis. Poster presented at: 10th Annual Coastal Dermatology Symposium; September 24-27, 2014; Sonoma, CA.1

Study Objective
To evaluate the efficacy, safety, and tolerability of Sebuderm Topical Gel on mild to moderate facial and scalp seborrheic dermatitis using a baseline comparison approach.1

Method
The study was conducted in 25 adults with mild to moderate facial and scalp seborrheic dermatitis at 1 clinical site in the United States. Photos and assessments were done at baseline, day 14, and day 28. The participants were instructed to apply the gel 2 times a day to the affected areas.1

Primary Endpoints
• Outcome of Investigator Global Assessment (IGA) and tolerability assessment conducted at each visit. The IGA rating scale was 0=clear, 1=almost clear, 3=moderate, 4=severe.  For study purposes, a score of 0 or 1 was considered a success while a score of 2 to 4 was classified as a failure.1
• Outcome of Subject Global Assessment (SGA) and tolerability assessment conducted at each visit. The SGA was scored from –1 to 3 as a response to the product grading from baseline, and the need for rescue medication. Participant tolerability was scored using the Visual Analog Scale to evaluate burning, stinging, and itching (scale 0-100 mm); 0=no symptoms and 100=extremely poor response.1

Results
Sebuderm Topical Gel demonstrated significant improvements from baseline for IGA with 33% improvement at day 14 and 52% improvement at day 28. The SGA efficacy improvement from baseline was 217% at day 14 and an additional 62% improvement from day 14 to day 28 was observed. Burning, stinging, and itching decreased from day 14 to day 28; however, few participants experienced total resolution of symptoms.1

Safety Notes
Overall treatment was well tolerated by the participants. No serious adverse events or adverse events occurred during the study. One participant experienced tolerability issues upon application of the gel. The tolerability was recorded as increase erythema and scaling of the scalp.1

Additional Resource
For more information on Sebuderm Topical Gel, please visit https://intraderm.com/sebuderm/.

Sebuderm Topical Gel from IntraDerm Pharmaceuticals is now available. The prescription nonsteroidal gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain in individuals with various types of dermatoses, including seborrhea and seborrheic dermatitis.

Considered a chronic form of eczema, seborrheic dermatitis can present on the body where there are many sebaceous glands. Although the exact cause is unknown, genes and hormones may play a role. Triggers for seborrheic dermatitis include stress, hormonal changes or illness, harsh detergents, solvents, chemicals and soaps, and cold dry weather, according to the National Eczema Association.

Sebuderm Topical Gel with Microcyn Technology is designed to target areas of the body where seborrheic dermatitis is present such as the scalp, beard area, behind ears, chest, and nasal-labial. The gel, which contains stabilized hypochlorous acid, is a nonoily, pH neutral gel dressing.

The gel should be applied to the affected area 2 to 3 times a day or as directed by a health care provider. For skin areas, apply the gel to the affected area and gently rub in. Repeat as needed to achieve a visible layer of the gel to ensure the affected area is covered. For scalp areas, part the hair and apply directly onto the affected area and rub in and spread over the affected area. Repeat as needed to cover the affected area. The gel should dry in 3 to 5 minutes, according to the product’s prescribing information.

Sebuderm Topical Gel has been shown to improve the appearance and symptoms of facial and scalp seborrheic dermatitis. The Dermatologist Product Spotlight provides a summary of the efficacy and tolerability study in individuals with seborrheic dermatitis treated with Sebuderm Topical Gel.

Efficacy and Tolerability Study
Draelos Z.  An evaluation of oculus SebuDerm–microcyn based gel on mild to moderate facial and scalp seborrheic dermatitis. Poster presented at: 10th Annual Coastal Dermatology Symposium; September 24-27, 2014; Sonoma, CA.1

Study Objective
To evaluate the efficacy, safety, and tolerability of Sebuderm Topical Gel on mild to moderate facial and scalp seborrheic dermatitis using a baseline comparison approach.1

Method
The study was conducted in 25 adults with mild to moderate facial and scalp seborrheic dermatitis at 1 clinical site in the United States. Photos and assessments were done at baseline, day 14, and day 28. The participants were instructed to apply the gel 2 times a day to the affected areas.1

Primary Endpoints
• Outcome of Investigator Global Assessment (IGA) and tolerability assessment conducted at each visit. The IGA rating scale was 0=clear, 1=almost clear, 3=moderate, 4=severe.  For study purposes, a score of 0 or 1 was considered a success while a score of 2 to 4 was classified as a failure.1
• Outcome of Subject Global Assessment (SGA) and tolerability assessment conducted at each visit. The SGA was scored from –1 to 3 as a response to the product grading from baseline, and the need for rescue medication. Participant tolerability was scored using the Visual Analog Scale to evaluate burning, stinging, and itching (scale 0-100 mm); 0=no symptoms and 100=extremely poor response.1

Results
Sebuderm Topical Gel demonstrated significant improvements from baseline for IGA with 33% improvement at day 14 and 52% improvement at day 28. The SGA efficacy improvement from baseline was 217% at day 14 and an additional 62% improvement from day 14 to day 28 was observed. Burning, stinging, and itching decreased from day 14 to day 28; however, few participants experienced total resolution of symptoms.1

Safety Notes
Overall treatment was well tolerated by the participants. No serious adverse events or adverse events occurred during the study. One participant experienced tolerability issues upon application of the gel. The tolerability was recorded as increase erythema and scaling of the scalp.1

Additional Resource
For more information on Sebuderm Topical Gel, please visit https://intraderm.com/sebuderm/.

Sebuderm Topical Gel from IntraDerm Pharmaceuticals is now available. The prescription nonsteroidal gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain in individuals with various types of dermatoses, including seborrhea and seborrheic dermatitis.

Considered a chronic form of eczema, seborrheic dermatitis can present on the body where there are many sebaceous glands. Although the exact cause is unknown, genes and hormones may play a role. Triggers for seborrheic dermatitis include stress, hormonal changes or illness, harsh detergents, solvents, chemicals and soaps, and cold dry weather, according to the National Eczema Association.

Sebuderm Topical Gel with Microcyn Technology is designed to target areas of the body where seborrheic dermatitis is present such as the scalp, beard area, behind ears, chest, and nasal-labial. The gel, which contains stabilized hypochlorous acid, is a nonoily, pH neutral gel dressing.

The gel should be applied to the affected area 2 to 3 times a day or as directed by a health care provider. For skin areas, apply the gel to the affected area and gently rub in. Repeat as needed to achieve a visible layer of the gel to ensure the affected area is covered. For scalp areas, part the hair and apply directly onto the affected area and rub in and spread over the affected area. Repeat as needed to cover the affected area. The gel should dry in 3 to 5 minutes, according to the product’s prescribing information.

Sebuderm Topical Gel has been shown to improve the appearance and symptoms of facial and scalp seborrheic dermatitis. The Dermatologist Product Spotlight provides a summary of the efficacy and tolerability study in individuals with seborrheic dermatitis treated with Sebuderm Topical Gel.

Efficacy and Tolerability Study
Draelos Z.  An evaluation of oculus SebuDerm–microcyn based gel on mild to moderate facial and scalp seborrheic dermatitis. Poster presented at: 10th Annual Coastal Dermatology Symposium; September 24-27, 2014; Sonoma, CA.1

Study Objective
To evaluate the efficacy, safety, and tolerability of Sebuderm Topical Gel on mild to moderate facial and scalp seborrheic dermatitis using a baseline comparison approach.1

Method
The study was conducted in 25 adults with mild to moderate facial and scalp seborrheic dermatitis at 1 clinical site in the United States. Photos and assessments were done at baseline, day 14, and day 28. The participants were instructed to apply the gel 2 times a day to the affected areas.1

Primary Endpoints
• Outcome of Investigator Global Assessment (IGA) and tolerability assessment conducted at each visit. The IGA rating scale was 0=clear, 1=almost clear, 3=moderate, 4=severe.  For study purposes, a score of 0 or 1 was considered a success while a score of 2 to 4 was classified as a failure.1
• Outcome of Subject Global Assessment (SGA) and tolerability assessment conducted at each visit. The SGA was scored from –1 to 3 as a response to the product grading from baseline, and the need for rescue medication. Participant tolerability was scored using the Visual Analog Scale to evaluate burning, stinging, and itching (scale 0-100 mm); 0=no symptoms and 100=extremely poor response.1

Results
Sebuderm Topical Gel demonstrated significant improvements from baseline for IGA with 33% improvement at day 14 and 52% improvement at day 28. The SGA efficacy improvement from baseline was 217% at day 14 and an additional 62% improvement from day 14 to day 28 was observed. Burning, stinging, and itching decreased from day 14 to day 28; however, few participants experienced total resolution of symptoms.1

Safety Notes
Overall treatment was well tolerated by the participants. No serious adverse events or adverse events occurred during the study. One participant experienced tolerability issues upon application of the gel. The tolerability was recorded as increase erythema and scaling of the scalp.1

Additional Resource
For more information on Sebuderm Topical Gel, please visit https://intraderm.com/sebuderm/.