Suspended
A Phase 2a, Proof of Concept, 24-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo
What is being tested
ARQ-252 cream 0.3%
+ NB-UVB phototherapy active treatment
+ NB-UVB phototherapy sham treatment
DrugDevice
Who is being recruted
Pigmentation Disorders+2
+ Skin Diseases
+ Vitiligo
Over 18 Years
+36 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: March 2021
Summary
Principal SponsorArcutis Biotherapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 4, 2021
Actual date on which the first participant was enrolled.This study is a Phase 2a, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 0.3% cream in combination with NB-UVB phototherapy treatment in subjects with non-segmental facial vitiligo. This study was prematurely terminated by the sponsor on 30-Jun-2021.
Official TitleA Phase 2a, Proof of Concept, 24-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo
Principal SponsorArcutis Biotherapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
114 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Pigmentation DisordersSkin DiseasesVitiligoSkin and Connective Tissue DiseasesHypopigmentation
Criteria
12 inclusion criteria required to participate
Subject is legally competent to sign and give informed consent.
Males and females ages 18 years and older (inclusive)
Clinical diagnosis of non-segmental vitiligo involving face.
A Facial Vitiligo Area Severity Index [F-VASI] score of ≥ 0.25 at baseline.
Show More Criteria
24 exclusion criteria prevent from participating
Subjects who have ever used skin bleaching treatments for treatment of vitiligo or other pigmented areas, eg, depigmenting agents such as monobenzyl ether of hydroquinone, including Benoquin® (Monobenzone)
Use of any other prior and concomitant therapy that is a contraindication to phototherapy or may otherwise interfere with the objective of the study as per discretion of the Investigator, such as drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of Baseline (Visit 2).
More than 33% leukotrichia in facial lesions (assessed via dermatoscope).
Other forms of vitiligo (eg, segmental vitiligo); or other skin depigmentation disorder that would confound study assessments.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorARQ-252 cream 0.3% BID with phototherapy.
Group II
Active ComparatorARQ-252 cream 0.3% BID with sham phototherapy
Group III
PlaceboARQ-252 Vehicle cream BID with active phototherapy
Group IV
PlaceboARQ-252 Vehicle cream BID with sham phototherapy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Suspended
Suspended
Arcutis Site 167
Coral Gables, United StatesSuspended
Arcutis Clinical Site 102
Rolling Meadows, United StatesSuspended
Arcutis Site 162
Austin, United StatesSuspended5 Study Centers