⚡Zoryve for Psoriasis, BTK Inhibitors Miss, and Keloid Protocol With Durable Results

Good morning — it’s Saturday, May 10, and we’re covering new trial results for topical roflumilast in scalp and body psoriasis, two BTK inhibitors that failed in atopic dermatitis, and more.

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Need To Know

Roflumilast Foam Clears Scalp and Body Psoriasis in ARRECTOR Trial

The ARRECTOR Phase 3 trial, published in JAMA Dermatology, found that once-daily roflumilast foam 0.3% (Zoryve) significantly improved both scalp and body psoriasis.

Among 432 patients enrolled, 66% achieved a clear or almost clear scalp score (S-IGA 0/1) at Week 8, compared to 28% on vehicle. For body psoriasis, 46% reached a clear or almost clear score (B-IGA 0/1) versus 20% on vehicle.

Itch relief was rapid, with significant improvement over vehicle observed as early as 24 hours post-application (P < 0.05).

Adverse event rates were low, and application-site irritation was minimal.

Roflumilast selectively inhibits phosphodiesterase 4, reducing inflammatory cytokines (TNF-α, IL-17, IL-23) while enhancing IL-10 expression. It also helps restore epidermal barrier function and reduces sensory neuron–mediated itch.

Study limitations include the short 8-week duration and the absence of an active comparator.

The foam’s alcohol-free, high-water-content formulation is designed for both hair-bearing and non–hair-bearing skin, offering a cosmetically elegant, once-daily topical that may simplify treatment and improve adherence—particularly for scalp and body involvement.

Rilzabrutinib Misses Efficacy Targets in Atopic Dermatitis

Sanofi’s rilzabrutinib—a selective, reversible Bruton’s tyrosine kinase inhibitor—did not meet key efficacy endpoints in a Phase 2 trial for atopic dermatitis, according to results published in the British Journal of Dermatology.

In this randomized trial, 124 adults with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids received rilzabrutinib (800 mg/day or 1200 mg/day) or placebo for 16 weeks.

Mean eczema severity (EASI score) reductions were 54% with 800 mg/day and 47% with 1200 mg/day, similar to placebo (43–47%). Clear or near-clear skin (IGA 0/1) was achieved by only 7% and 15% of patients receiving the lower and higher doses, respectively.

However, rilzabrutinib led to a ≥4-point reduction in itch severity (PP-NRS) in 19–21% of patients, compared to 11–13% with placebo. Itch improvement was observed as early as day 1 in the 1200 mg/day group.

Rilzabrutinib was generally well tolerated. Nausea and diarrhea were the most common adverse events.

Although the primary endpoints were not met, rilzabrutinib may be beneficial in conditions where itch is a central symptom—highlighted by its recent success in chronic spontaneous urticaria. The drug is also in development for pemphigus.

Quick Hits

> Topical BTK Inhibitor Also Falls Short in Atopic Dermatitis: A topical Bruton’s tyrosine kinase (BTK) inhibitor, atuzabrutinib, also underperformed in a Phase 2a trial for mild-to-moderate atopic dermatitis, according to a study published in The Journal of Investigative Dermatology. During a 2-week double-blind period, patients applied atuzabrutinib to one target lesion and placebo to another, followed by a 4-week open-label phase in which all lesions received atuzabrutinib. By Day 15, lesional IGA scores (0–4 scale) declined by –0.94 with atuzabrutinib and –0.74 with placebo. In the open-label phase, modest improvement was seen, with 33% achieving clear or near-clear skin (IGA 0/1) at Day 43. However, the lack of a control arm in the extension phase and small sample size limit interpretation. RNA sequencing and immunohistochemistry revealed minimal immunologic impact, reinforcing the limited role of topical BTK inhibition in mild atopic dermatitis.

> Stapokibart Shows High Efficacy Across All Body Regions in Atopic Dermatitis: Stapokibart—a next-generation IL-4Rα inhibitor approved in China—demonstrated high and consistent efficacy across all body regions in a post hoc analysis of a Phase 3 trial involving 500 adults with moderate-to-severe atopic dermatitis. By Week 16, mean percentage reductions in eczema severity (EASI score) ranged from 71% to 76% across all regions, compared to approximately 30% in placebo-treated patients. Notably, improvements in the head and neck—often resistant to topical therapies—were on par with other sites. Efficacy continued to deepen through Week 52, with all sites achieving over 90% reduction in EASI score from baseline. Unlike dupilumab, stapokibart blocks IL-4 and IL-13 via a distinct IL-4Rα epitope and has unique cross-species reactivity.

> ASAP Protocol Delivers High Keloid Clearance With Low Recurrence: A 10-year follow-up study in IJD found that a non-surgical combination treatment for keloids achieved long-term clearance in patients with skin of color. The regimen—known as the ASAP protocol—included hydrocolloid dressings for initial softening, monthly intralesional injections of 5-fluorouracil and triamcinolone, and pre-injection IPL to further reduce stiffness and target vascularity. Among 79 keloids treated in 55 patients, 82% achieved complete resolution, and 95% received the highest level of patient-reported satisfaction. Only one case (1%) recurred. Pain was the only adverse effect, reported in 9% of cases. Median treatment duration was 10 months, with follow-up ranging from 19 to 123 months. Although the study lacked a control group, the results suggest a durable, well-tolerated option for treating keloids in skin of color.

> Acne Nutraceutical Shows Efficacy With Caveats: A randomized, double-blind trial in the Journal of Cosmetic Dermatology evaluated a novel oral nutraceutical (Nutrafol SKIN) in 102 women with mild-to-moderate acne. At week 12, 44% of participants receiving the supplement achieved clear or almost clear skin (IGA 0/1) compared to 13% on placebo (P < 0.01). However, lesion count changes were less convincing. Inflammatory lesions declined similarly in both groups; non-inflammatory lesions decreased by 48% with the supplement—numerically greater than placebo—but the difference did not reach significance (P = 0.16). The nutraceutical contains ingredients targeting systemic acne drivers, including zinc, berberine, maca, lycopene, and probiotics. It was well tolerated, with one participant discontinuing due to nausea.

Derm Picks

Quizzes, cases, and perspectives to sharpen your clinical eye.

🖼️ Image Challenge

• Butterfly-shaped hypertrophic plaques on the buttocks (View)

• Multiple erythematous annular scaly plaques (View)

• Multiple scalp and neck lesions in an 80-year-old man (View)

• A newborn with a necrotic scalp lesion (View)

🔎 Under the Dermatoscope

• Two-step-7-pink rule to simplify dermoscopy of amelanotic skin lesions (Read)

📚 Guides & Reviews

• European guideline (EuroGuiDerm) on atopic eczema: living update (Read)

• Biologics for moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis (Read)

• Local corticosteroids for alopecia areata: a narrative review (Read)

• A clinician’s guide to dupilumab-related ocular surface disease (Read)

• Anti-androgen therapy for female pattern hair loss: a clinical review (paywall restricted) (Read)

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