ARRECTOR
Trial question
What is the role of roflumilast foam in patients with psoriasis on the scalp and body?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 432
432 patients (243 female, 189 male).
Inclusion criteria: patients, aged ≥ 12 years, with plaque psoriasis affecting up to 25% of the scalp and body.
Key exclusion criteria: planned excessive exposure of treated areas to natural or artificial sunlight, tanning bed, or other LED; planned initiation or changes to concomitant medication that could affect psoriasis; current diagnosis of non-plaque forms of psoriasis or drug-induced psoriasis; discontinuation of current psoriasis treatment inadvisable.
Interventions
N=281 roflumilast foam (application of roflumilast 3% emollient foam once daily for 8 weeks).
N=151 vehicle (vehicle foam applied once daily to affected areas for 8 weeks).
Primary outcome
Scalp-Investigator Global Assessment success at week 8
66.4%
27.8%
66.4 %
49.8 %
33.2 %
16.6 %
0.0 %
Roflumilast
foam
Vehicle
Significant
increase ▲
NNT = 2
Significant increase in Scalp-Investigator Global Assessment success at week 8 (66.4% vs. 27.8%; AD 37.1%, 97.5% CI 25.7 to 48.6).
Secondary outcomes
Significant increase in Body-Investigator Global Assessment success at week 8 (45.5% vs. 20.1%; AD 24.8%, 97.5% CI 13.6 to 36).
Significant increase in Scalp Itch-NRS at week 8 (65.3% vs. 30.3%; AD 35.4%, 97.5% CI 22.3 to 48.6).
Significant increase in Worst Itch-NRS at week 8 (63.1% vs. 30.1%; AD 32.8%, 97.5% CI 18.6 to 46.9).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients, aged ≥ 12 years, with plaque psoriasis affecting up to 25% of the scalp and body, roflumilast foam was superior to vehicle with respect to a Scalp-Investigator Global Assessment success at week 8.
Reference
Melinda J Gooderham, Javier Alonso-Llamazares, Jerry Bagel et al. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 May 7:e251136. Online ahead of print.
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