Keratolytic Agent for Management of Scaling and Itch for Skin Diseases

Sonoma Pharmaceuticals, Inc recently launched Loyon in the United States. 

Scaling, burning, and itching are common symptoms associated various types of dermatoses including psoriasis, cradle cap, seborrhea, and seborrheic dermatitis. The gentle removal of irritating scales and encrustations is important in treating scaly skin diseases to prevent irritations, pinpoint bleeding, and infections.

Sonoma Pharmaceuticals, Inc recently launched the nonsterile, topical solution Loyon in the United States. Loyon is indicated to manage and relieve the itching, erythema, and scaling experienced with various types of dermatoses. The product received a new 510(k) clearance from the FDA in March 2017. The product’s combination of the dry emollient Cetiol CC and the medical silicone oil dimethicone is easily applied, absorbs quickly, and spreads well due to its low surface tension. Under the supervision of a health care provider, Loyon, via the accompanying dispensing spray pump, should be applied directly to dry affected areas and gently massaged in. Loyon should stay on the skin for at least 3 hours. Longer exposure times (eg, overnight) are possible as directed by a health care provider. After the adequate exposure time, the solution can be washed off with a mild shampoo or a cleanser. Depending on the preference and severity of the disease, Loyon can be applied as needed, according to the product insert.

A survey of dermatologists and patients with psoriasis indicated high satisfaction with Loyon, with 88% of dermatologists indicating that they were satisfied or very satisfied with the therapy; this impression was further confirmed by 87% of the patients surveyed. Furthermore, 2 clinical studies demonstrated the efficacy and safety of Loyon in pediatric and adult populations.

The Dermatologist Product Spotlight provides a summary of the proof-of-concept pilot study in infants and children with cradle cap and a single-center study in adults with psoriasis.

Proof-of-Concept Pilot Study

Hengge UR. Topical non-medicated LOYON^® in facilitating the removal of scaling in infants and children with cradle cap: a proof-of-concept pilot study. Dermatol Ther (Heidelb). 2014;4(2):221-232.¹

Study Objective

To evaluate the safety and efficacy of topically applied, nonmedicated Loyon in facilitating the removal of scaling in infants and children with cradle cap without inducing spot bleedings.¹

Method

This single-center, proof-of-concept, 8-day pilot study included 1 to 3 applications of Loyon. Clinical assessment of scaling and redness was performed using 5-point scales from 0 to 3. Treatment success was defined as the reduction of the scaling baseline score by at least 2 points. Time to treatment success was determined as the difference of the visit of the first occurrence of treatment success minus one (baseline visit day). A questionnaire on the subjective efficacy and usability was distributed to parents/legal guardians.¹

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Population

Twenty infants and children aged 3 to 36 months with clinically diagnosed cradle cap on the scalp (scaling score ≥2) were enrolled in the study. For study inclusion, the physical examination of the scalp had to be without abnormal findings, unless the investigator considered an abnormality irrelevant to the study’s outcome.¹

Primary Endpoint

• Scaling in the target area of the scalp and treatment success.¹

Secondary Endpoints

• Presence of spot bleedings, redness, time to treatment success, and the analysis of the parent/legal guardian questionnaire.¹

Results

The study showed that Loyon was well tolerated, and safe and effective in facilitating the removal of scaling in infants and children with cradle cap. A reduction in scaling intensity from moderate or severe to very mild or mild was seen in 80% of the patients. Treatment success was achieved in 50% of patients. No pinpoint bleeding was observed during the study duration. Feedback from parents/legal guardians rated the overall treatment as “good.”

Safety Notes

A total of 7 nonserious adverse events (AEs) of mild (n=5) to moderate (n=2) intensity were reported. Two AEs concerned itching and were assessed as probably related to the study preparation and the procedure. In another child, soft yellow crusts with tiny vesicles and no signs of infection or pruritus at the application site were noted, and was assessed as possibly related to the study preparation.¹

Single-Center Study

Hengge UR, Röschmann K, Candler H. Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis. Psoriasis: Targets and Therapy. 2017;7:41-49.²

Study Objective

To assess the effectiveness and tolerability of Loyon in the removal of scaling after topical application in patients with psoriasis corporis or psoriasis capitis compared with baseline.²

Method

For this single-center, noninterventional clinical trial, patients with psoriasis capitis or psoriasis corporis received once-daily Loyon treatment for 7 days. The 2 target areas were psoriasis affected skin, located on the scalp or body. On day 1 (baseline), 2 target lesions were selected and documented in the case report form. For psoriasis corporis, the Psoriasis Area Severity Index (PASI) score was calculated, and for psoriasis capitis, Psoriasis Scalp Severity Index (PSSI) score was calculated. Baseline scaling scores and redness scores were calculated for the 2 target lesions of the scalp or the body on a 5-point scale each. The first treatment was applied in the study center, and patients washed off the product at home at the earliest 3 hours after application. Treatments on days 2 and 3 were performed by patients in their private setting. On day 4, patients returned to the study center for evaluation. Treatments on days 5, 6, and 7 were again done by patients. On day 8, patients returned to the study center for a final visit.²

Population

Forty patients (mean age 48 years) with psoriasis on the scalp or on the body with a scaling score of ≥1 on a 5-point scale were included. The patients were most affected by psoriasis capitis (70%).²

Primary Endpoint

• Reduction in scaling score. The scaling scores were documented within the assessment of PSSI or PASI scores, for each patient and target lesion.²

Secondary Endpoints

• PSSI or PASI scores and time to treatment success. A treatment success was defined as reduction in scaling of at least 1 grade.²

Results

The study demonstrated that Loyon is a safe, well-tolerated, practicable, and efficient compound that can be implemented in standard psoriatic care. A statistically significant decrease in scaling of 36.8% after 7 days of treatment was observed in patients with psoriasis capitis. Treatment success was achieved in 76.8% of patients with psoriasis capitis, and time to treatment success was evaluated to be 4.14 days for those patients and 4.33 days for patients with psoriasis corporis. Among patients with psoriasis capitis, a statistically significant reduction to a mean PSSI of 8.7±1.2 was observed 3 days after treatment, with a further decrease of mean PSSI to 7.9±0.9 after 7 days of treatment, corresponding to a decrease in total PSSI by 33.4% after 7 days of therapy. Comparable effects were detected when assessing the PASI of patients with psoriasis corporis. At baseline patients were assessed to have a mean PASI of 2.0±0.2. After 3 days of treatment, a reduction to a mean PASI of 1.8±0.2 was documented, with a further decrease in PASI to 1.7±0.2 after 7 days of treatment. Responder analysis revealed that 54.5% of patients achieved PASI 25 after 7 days of treatment.²

Safety Notes

No serious AEs occurred. In total, 1 AE was noted, which was assessed not to be product related.²

Additional Resource

For more information about Loyon, please visit https://intraderm.com/loyon/.