Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial.
J Am Acad Dermatol
; 90(5): 986-993, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38253129
ABSTRACT
BACKGROUND:
The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions.OBJECTIVE:
Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD).METHODS:
In this phase 3, double-blinded trial, patients with SD were randomly assigned (21 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed.RESULTS:
79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast 43.0%; vehicle 25.7%; P < .001) and week 4 (roflumilast 73.1%; vehicle 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events.LIMITATIONS:
Study limitations include the 8-week treatment period for this chronic condition.CONCLUSIONS:
Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Benzamidas
/
Dermatitis Seborreica
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
/
Adult
/
Humans
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2024
Tipo del documento:
Article