Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Arcutis Biotherapeutics, Inc.
Study ID
NCT05028582
Phase
PHASE3
Status
Completed

Conditions

  • Scalp Psoriasis

Eligibility Criteria

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

Interventions

  • Roflumilast Foam 0.3% — DRUG
    Roflumilast foam 0.3%
  • Vehicle Foam — DRUG
    Vehicle foam matched to roflumilast 0.3% foam.

Study Details

This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.

Key Dates

Start date
Aug 24, 2021
Status verified
Jul 2025
Primary completion
Jun 3, 2022
Completion
Jun 3, 2022

Study Design

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

Arms

  • Active Comparator: Roflumilast Foam 0.3%
    Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% once daily (qd) for 8 weeks.
  • Placebo Comparator: Vehicle Foam
    Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.

Primary Outcome Measure

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

Locations (36)

FacilityCityStateZIPSite coordinators
Arcutis Biotherapeutics Clinical Site 01ScottsdaleArizona85255-
Arcutis Biotherapeutics Clinical Site 50Beverly HillsCalifornia90212-
Arcutis Biotherapeutics Clinical Site 45EncinitasCalifornia92024-
Arcutis Biotherapeutics Clinical Site 64San DiegoCalifornia92123-
Arcutis Biotherapeutics Clinical Site 72Santa AnaCalifornia92701-
Arcutis Biotherapeutics Clinical Site 21Santa MonicaCalifornia90404-
Arcutis Biotherapeutics Clinical Site 33ClearwaterFlorida33756-
Arcutis Biotherapeutics Clinical Site 42Coral GablesFlorida33134-
Arcutis Biotherapeutics Clinical Site 57Delray BeachFlorida33484-
Arcutis Biotherapeutics Clinical Site 31North Miami BeachFlorida33162-
Arcutis Biotherapeutics Clinical Site 05OrlandoFlorida32819-
Arcutis Biotherapeutics Clinical Site 65SanfordFlorida32771-
Arcutis Biotherapeutics Clinical Site 12TampaFlorida33613-
Arcutis Biotherapeutics Clinical Site 22PlainfieldIllinois46168-
Arcutis Biotherapeutics Clinical Site 10Rolling MeadowsIllinois60008-
Arcutis Biotherapeutics Clinical Site 15LouisvilleKentucky40217-
Arcutis Biotherapeutics Clinical Site 04Lake CharlesLouisiana70605-
Arcutis Biotherapeutics Clinical Site 02RockvilleMaryland20850-
Arcutis Biotherapeutics Clinical Site 28RockvilleMaryland20850-
Arcutis Biotherapeutics Clinical Site 20DetroitMichigan48202-
Arcutis Biotherapeutics Clinical Site 14New BrightonMinnesota55112-
Arcutis Biotherapeutics Clinical Site 44Saint JosephMissouri64506-
Arcutis Biotherapeutics Clinical Site 34East WindsorNew Jersey08520-
Arcutis Biotherapeutics Clinical Site 51RochesterNew York14623-
Arcutis Biotherapeutics Clinical Site 63The BronxNew York10462-
Arcutis Biotherapeutics Clinical Site 23High PointNorth Carolina27262-
Arcutis Biotherapeutics Clinical Site 25PortlandOregon97223-
Arcutis Biotherapeutics Clinical Site 27PittsburghPennsylvania15213-
Arcutis Biotherapeutics Clinical Site 06KnoxvilleTennessee37922-
Arcutis Biotherapeutics Clinical Site 13ArlingtonTexas76011-
Arcutis Biotherapeutics Clinical Site 11AustinTexas78759-
Arcutis Biotherapeutics Clinical Site 41College StationTexas77845-
Arcutis Biotherapeutics Clinical Site 24San AntonioTexas78218-
Arcutis Biotherapeutics Clinical Site 54San AntonioTexas78213-
Arcutis Biotherapeutics Clinical Site 07West JordanUtah84088-
Arcutis Biotherapeutics Clinical Site 17NorfolkVirginia23502-

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