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Reviewing the Latest Developments in Pediatric Non-Steroidal Topicals

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Nnena Agim, MD, presented a comprehensive update on non-steroidal topical therapies, highlighting off-label uses and recent FDA approvals in a session at the SPD's annual meeting.

Adult applying topical cream on elbow of a young child
Image Credit: © Надежда Урюпина - stock.adobe.com

At the 2024 Society for Pediatric Dermatology Annual Meeting in Toronto, ON, Nnena Agim, MD, of North Dallas Dermatology Associates, presented a session titled “Update on Non-Steroidal Topical Therapies.”

This session provided an in-depth overview of the latest advancements and updates in non-steroidal topical treatments, particularly for pediatric patients.

Off-Label Use and Consensus Statements

One of the central themes of Agim's talk was the off-label use of non-steroidal topicals in pediatric dermatology. Despite not always being approved by the US Food and Drug Administration (FDA) for children, many of these treatments are widely recommended and used based on consensus statements from dermatological associations.

These treatments offer ease of administration, limited systemic absorption, and the ability to reverse adverse effects. They also provide visual cues for proper dosing, making them suitable for managing various dermatological conditions in children.

Key Non-Steroidal Topical Treatments

Agim highlighted several key non-steroidal topicals, discussing their FDA-approved indications, off-label uses, and effectiveness in treating pediatric dermatological conditions.

Tapinarof

Tapinarof, currently FDA-approved for use in individuals aged 18 and older, has shown promise for younger populations with psoriasis and eczema. An supplemental New Drug Application for its use in children aged 2 and up was accepted in April 2024.

Roflumilast

Roflumilast is FDA-approved for use in children aged 6 and older for its cream formulation and aged 9 and older for the foam formulation. It is particularly effective in treating seborrheic dermatitis and has been well-tolerated across diverse hair types. Roflumilast also shows improvement in post-inflammatory dyspigmentation, making it a versatile option for pediatric dermatology.

Ruxolitinib

Ruxolitinib is FDA-approved for patients aged 12 and older for the treatment of nonsegmental vitiligo involving up to 20% of the body surface area. It is also indicated for mild to moderate atopic dermatitis but is contraindicated in immunosuppressed patients. This limitation requires careful patient selection and monitoring.

Birch Triterpenes

FDA-approved for children as young as 6 months, birch triterpenes are indicated for conditions like junctional or dystrophic epidermolysis bullosa. However, despite their approval, they remain largely inaccessible in the market, posing challenges for widespread clinical use.

Cantharidin

Cantharidin is FDA-approved for treating molluscum contagiosum in children aged 2 years and older. It is not suitable for use on compromised skin or mucous membranes and is not prescribed as a take-home medication due to its potency and application restrictions.

Berdazimer

Berdazimer is another FDA-approved treatment for molluscum contagiosum, suitable for children aged 1 year and older. It should be avoided on eczematous skin and around the periocular area.

Clascoterone

Clascoterone, a topical anti-androgen therapy, is FDA-approved for treating acne vulgaris in patients aged 12 and older. It has shown potential in managing hidradenitis suppurativa as well. However, it comes with precautions, including the risk of HPA axis suppression, hyperkalemia, and amenorrhea.

Trifarotene

Trifarotene is a topical retinoid cream approved for treating acne in children aged 9 years and older. Patients are advised to avoid excessive sun exposure and use on inflamed or damaged skin to prevent adverse reactions.

Combination Therapies

Agim also discussed the efficacy of combination therapies such as clindamycin/adapalene/benzoyl peroxide, which is FDA-approved for acne treatment in patients aged 12 and older. These combinations are known for their photosensitivity risks but offer robust treatment options for acne.

Beremagene Geperpavec

Beremagene geperpavec is a gene therapy approved for children as young as 6 months, specifically for those with a confirmed collagen VII mutation in epidermolysis bullosa.

Conclusions

The current landscape of non-steroidal topical therapies in pediatric dermatology offer significant benefits, including ease of use and minimized systemic absorption, making them suitable for young patients. However, many are used off-label, highlighting the need for continued research and consensus-building to ensure safe and effective use in pediatric populations.

Reference

Agim N. Update on non-steroidal topical therapies. Presented at the 2024 Society for Pediatric Dermatology Annual Meeting, July 11-14; Toronto, ON.

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