⚡Weekly Acne Agent, Rosacea Pill Debuts, and Wart Clearance

Good morning — it's Saturday, Apr. 5, and we're covering Xyngari for acne, Emrosi’s rosacea launch, and more — plus a new section: Derm Picks.

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Need To Know

Xyngari Advances as First Once-Weekly Topical for Acne

Dermata Therapeutics announced its investigational acne therapy Xyngari hit all primary endpoints in the Phase 3 STAR-1 trial—positioning it as a potential first-in-class once-weekly topical for moderate to severe acne.

The trial enrolled 520 participants aged 9 and older, randomized to either Xyngari or placebo once weekly for 12 weeks.

Nearly twice as many patients treated with Xyngari achieved clear or almost clear skin (IGA 0/1) than those on placebo (29% vs. 15%, P < 0.001). The treatment also significantly reduced inflammatory (−17 vs. −13) and noninflammatory (−17 vs. −12) lesion counts, with both differences favoring Xyngari (both P < 0.001).

For context, a 2016 trial of adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo) showed a 16% treatment difference over placebo in achieving IGA 0/1. Xyngari’s 14% difference is comparable, although cross-trial comparisons should be interpreted with caution. 

The drug was well tolerated, with no serious adverse events noted.

Xyngari—derived from a naturally sourced freshwater sponge—acts through both mechanical and chemical mechanisms. Silica spicules exfoliate the skin and help clear closed comedones, while naturally occurring compounds deliver antimicrobial and anti-inflammatory effects.

Following these results, Dermata is launching a second Phase 3 STAR-2 trial later this year, paving the way toward potential FDA approval.

Quick Hits

> Emrosi Launches for Rosacea with Dual-Action Efficacy: Emrosi (40 mg modified-release minocycline) has launched in the U.S. following FDA approval for inflammatory lesions of rosacea, with Phase 3 trials also showing improvements in erythema. The MVOR-1 and MVOR-2 trials, published in JAMA Dermatology, demonstrated Emrosi’s superiority over both doxycycline and placebo. Among 653 participants, 60–65% of those receiving Emrosi achieved clear or almost clear skin (IGA 0/1) at 16 weeks, compared to 31–46% with doxycycline and 27–31% with placebo. Lesion counts fell by nearly 80%, versus 61–64% with doxycycline and 46–47% with placebo. Importantly, nearly 30% of Emrosi-treated patients achieved a ≥2-point reduction on the Clinician’s Erythema Assessment scale (0–4), more than double the placebo response. The formulation’s strength lies in its low-dose dual-release design, delivering both immediate and sustained minocycline exposure.

> 0.5 mL Candida Antigen May Set New Standard for Warts: Findings from a Phase 2a trial suggest that 0.5 mL of purified Candida albicans antigen (Candin) may offer greater clinical benefit than the standard 0.3 mL dose. Among 169 adults, 80% of patients receiving 0.5 mL injected into a single wart achieved clearance of the treated lesion, compared to 42% in the placebo group. With the 0.3 mL dose, clearance rates were 66% when injecting a single wart and 73% when injecting up to four warts. Injections were administered every 2 weeks for up to 10 sessions. Notably, only the 0.5 mL group achieved statistically significant clearance of both treated and distant untreated warts compared to placebo (51% vs. 16%; P = 0.0014), suggesting a dose-dependent systemic effect. All dosing regimens were safe and well tolerated. A Phase 3 study is now underway to confirm these findings.

> Pfizer Abandons Etrasimod for Alopecia Areata: Etrasimod—an oral sphingosine 1-phosphate receptor modulator—failed to meet efficacy endpoints in a Phase 2 trial of 80 adults with moderate to severe alopecia areata. The results were published in JEADV. At 24 weeks, mean percent change in alopecia severity (SALT score) from baseline was −14% with etrasimod 2 mg, −21% with etrasimod 3 mg, and 0% with placebo—though neither dose reached statistical significance. In the open-label extension, SALT scores improved further with the 3 mg dose, falling 45% from baseline by week 44. The safety profile was reassuring and aligned with etrasimod’s use in ulcerative colitis. Despite numerical improvements, the lack of statistical significance led Pfizer to discontinue development of etrasimod for alopecia areata—a notable setback for S1P modulators in dermatology.

> Nemolizumab’s Efficacy Strengthens Over Time in Prurigo Nodularis: New 68-week data from a phase 2/3 trial published in the British Journal of Dermatology show that nemolizumab’s clinical effects in prurigo nodularis not only persisted but strengthened over time. In the open-label extension, 226 patients aged ≥13 years who completed the initial 16-week trial received nemolizumab plus topical corticosteroids for an additional 52 weeks. Nemolizumab 30 mg reduced pruritus severity by 79% at week 68, up from 61% at week 16. Nodule counts decreased by 93%, and 70% of patients achieved clear or almost clear skin (IGA 0/1). Patients also reduced their topical corticosteroid use by 50%. No new safety concerns emerged. Watch how nemolizumab targets IL-31 signaling here.

> Stable Labs Set Deucravacitinib Apart from JAK1/2/3 Inhibitors: A pooled analysis of the POETYK PSO-1, PSO-2, and long-term extension trials assessed the laboratory safety of deucravacitinib in 1519 patients with moderate to severe psoriasis. Over three years, no clinically meaningful changes were observed in key lab parameters—including liver transaminases, creatine phosphokinase, lipids, and hematology markers. Severe lab abnormalities (Grade ≥3) were rare. Only four patients discontinued due to lab-related adverse events: three for elevated creatine phosphokinase and one for hepatic dysfunction. Deucravacitinib’s stable lab results highlight its safety and TYK2 selectivity, distinguishing it from JAK1/2/3 inhibitors.

Derm Picks

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

🖼️ Image Challenge

• An infant with congenital scalp, nail, and limb anomalies (View)

• Annular lesions in an HIV-positive man (View)

• Recent changes in a speckled pigmented lesion (View)

🔎 Under the Dermatoscope

• A scabies case confirmed by Dermoscopic Burrow Ink Test (D-BIT) (View)

• An asymptomatic small, pink plaque on the arm of an elderly woman (View)

📚 Guides & Reviews

• First meta-analysis of treatments for periorbital hyperpigmentation (Read)

• Part 1 of the 2024 updated international guidelines for congenital ichthyoses now published (Read)

• Comprehensive review of subcutaneous methotrexate in adults with psoriasis (Read)

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