Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

Conditions

• Seborrheic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast Foam 0.3% — DRUG
  Roflumilast foam for topical application.
• Vehicle foam — DRUG
  Vehicle foam for topical application.

Study Details

This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.

Key Dates

Start date

Dec 4, 2019

Status verified

Jun 2023

Primary completion

Aug 18, 2020

Completion

Aug 21, 2020

Study Design

Enrollment

226 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Roflumilast Foam 0.3%
  Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.
• Placebo Comparator: Vehicle Foam
  Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.

Primary Outcome Measure

Achievement of Investigator Global Assessment (IGA) Success at Week 8 [ Time Frame: Week 8 ]

Locations (22)

Find similar trials in Fremont, CA

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