Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tapinarof cream, 1% — DRUG
  Tapinarof cream, 1%, applied daily to affected areas by subjects or their caregivers based on vIGA-AD. Subjects are advised to choose the application time they prefer and apply the study drug at that approximate time each day of study participation.

Study Details

This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Key Dates

Start date

Oct 28, 2021

Status verified

May 2025

Primary completion

Feb 29, 2024

Completion

Mar 7, 2024

Study Design

Enrollment

728 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: tapinarof cream
  Subjects entering with vIGA-AD (Validated Investigator Global Assessment of Atopic Dermatitis) ≥1 receive treatment with study drug until they achieve vIGA-AD=0, at which time treatment is discontinued and subjects are monitored for durability of response (remittive response). If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved. Subjects entering with a vIGA-AD=0 discontinue treatment and are monitored for duration of remittive response. If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved. This treatment and re-treatment pattern of use continue until the end of the study.

Primary Outcome Measure

Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events [ Time Frame: Baseline to Week 49 ]

Locations (102)

Find similar trials in Birmingham, AL

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