Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Organon and Co
Study ID
NCT05186805
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis

Key Dates

Start date
Nov 15, 2021
Status verified
Sep 2025
Primary completion
Aug 24, 2022
Completion
Aug 24, 2022

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tapinarof cream
    Tapinarof (DMVT-505) cream, 1% applied topically once daily

Primary Outcome Measure

Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Dermavant Investigative SiteThousand OaksCalifornia91320-
Dermavant Investigative SiteCentennialColorado80112-
Dermavant Investigative SiteCoral GablesFlorida33146-
Dermavant Investigative SiteHialeahFlorida33016-
Dermavant Investigative SiteMiami LakesFlorida33014-
Dermavant Investigative SiteChicagoIllinois60611-
Dermavant Investigative SiteSummervilleSouth Carolina29445-
Dermavant Investigative SiteHoustonTexas77030-
Dermavant Investigative SiteSan AntonioTexas78213-

Find similar trials in Thousand Oaks, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Dermavant Investigative Site· Thousand Oaks, CADermavant Investigative Site· Centennial, CODermavant Investigative Site· Coral Gables, FLDermavant Investigative Site· Hialeah, FLDermavant Investigative Site· Miami Lakes, FLDermavant Investigative Site· Chicago, IL

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