Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Arcutis Biotherapeutics, Inc.
Study ID
NCT03916081
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast Cream 0.05% — DRUG
    Roflumilast 0.05% cream for topical application
  • Roflumilast Cream 0.15% — DRUG
    Roflumilast 0.15% cream for topical application
  • Vehicle Cream — DRUG
    Inactive vehicle cream matched to roflumilast cream for topical application.

Study Details

The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.

Key Dates

Start date
May 31, 2019
Status verified
Aug 2022
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast Cream 0.05%
    Participants apply roflumilast cream 0.05% QD for 28 days.
  • Active Comparator: Roflumilast Cream 0.15%
    Participants apply roflumilast cream 0.15% QD for 28 days.
  • Placebo Comparator: Vehicle Cream
    Participants apply vehicle cream QD for 28 days.

Primary Outcome Measure

Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 [ Time Frame: Baseline and Week 4 ]

Locations (17)

FacilityCityStateZIPSite coordinators
Arcutis Clinical Site 25ScottsdaleArizona85254-
Arcutis Clinical Site 01San DiegoCalifornia92123-
Arcutis Clinical Site 19HialeahFlorida33016-
Arcutis Clinical Site 18MiamiFlorida33174-
Arcutis Clinical Site 17SanfordFlorida32771-
Arcutis Clinical Site 16BoiseIdaho83713-
Arcutis Clinical Site 12IndianapolisIndiana46250-
Arcutis Clinical Site 13PlainfieldIndiana46168-
Arcutis Clinical Site 15MetairieLouisiana70006-
Arcutis Clinical Site 03FridleyMinnesota55432-
Arcutis Clinical Site 02High PointNorth Carolina27262-
Arcutis Clinical Site 08BexleyOhio43209-
Arcutis Clinical Site 23PittsburghPennsylvania15213-
Arcutis Clinical Site 20MurfreesboroTennessee37130-
Arcutis Clinical Site 09College StationTexas77845-
Arcutis Clinical Site 04San AntonioTexas78213-
Arcutis Clinical Site 21RichmondVirginia23224-

Find similar trials in Scottsdale, AZ

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Arcutis Clinical· Scottsdale, AZArcutis Clinical· San Diego, CAArcutis Clinical· Hialeah, FLArcutis Clinical· Miami, FLArcutis Clinical· Sanford, FLArcutis Clinical· Boise, ID

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