This study will assess the safety and efficacy of ARQ-252 cream in combination with NB-UVB phototherapy treatment in individuals with non-segmental facial vitiligo.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
ARQ-252 cream 0.3%
ARQ-252 Vehicle cream
NB-UVB phototherapy active treatment
Arcutis Site 123
San Diego, California, United States
Arcutis Site 167
Coral Gables, Florida, United States
Arcutis Clinical Site 102
Rolling Meadows, Illinois, United States
Arcutis Site 162
Austin, Texas, United States
Percentage of Participants Achieving 75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI) Score (F-VASI75) at Week 24
Achievement of F-VASI75 was declared with a ≥75% improvement from Baseline in F-VASI. F-VASI measures the % of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (none), 10% (only specks), 25% (pigmented area \> depigmented area), 50% (depigmented and pigmented areas equal), 75% (depigmented area \> pigmented area), 90% (specks of pigment), or 100% (no pigment). F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Time frame: Week 24
Percentage of Change From Baseline in F-VASI Score
The mean (SD) percentage change from baseline in F-VASI scores across study time points is presented. F-VASI measures the % of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (none), 10% (only specks), 25% (pigmented area \> depigmented area), 50% (depigmented and pigmented areas equal), 75% (depigmented area \> pigmented area), 90% (specks of pigment), or 100% (no pigment). F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Facial Body Surface Area (F-BSA) Score
The change from baseline in F-BSA affected over time. The endpoint was not assessed due to early study termination.
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Vitiligo Noticeability Scale (VNS) Score
The VNS is a patient-reported measure of vitiligo treatment success, which has a 5-point scale, with 1 being more noticeable and 5 being no longer noticeable. The VNS will be completed for vitiligo on the face. The endpoint was not assessed due to early study termination.
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NB-UVB phototherapy sham treatment
Arcutis Clinical Site 163
Pflugerville, Texas, United States
Time frame: Weeks 4, 8, 12, 16, 20, and 24.
Change From Baseline in Vitiligo Quality of Life (VitiQOL)
Change from Baseline in the VitiQoL, an instrument consisting of 16-item questionnaire (with a 7-point numerical scale from 0 - Not at all to 6 - All of the time) designed to assess disease specific health-related quality of life (HRQL) in patients suffering from vitiligo and also provide an objective measure of disease status, burden of disease, and treatment outcome. The endpoint was not assessed due to early study termination.
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Patient Global Impression of Change-Vitiligo (PaGIC-V)
The PaGIC-V category, a 7-point scale comparing facial vitiligo at baseline with the subject's treated facial vitiligo at the study visit (with 1- very much improved and 7 - very much worse), and time to achieve a PaGIC-V of very much improved or much improved. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving 50% Reduction in F-VASI Score (F-VASI50)
The percentage of participants achieving F-VASI50. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Time to Achieve F-VASI50
The time to achieve F-VASI50. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving 90% Reduction in F-VASI Score (F-VASI90)
The percentage of participants achieving F-VASI90. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Achievement of Success in Facial Static Investigator Global Assessment (FsIGA)
The percentage of subjects with FsIGA, (a four point scale of vitiligo severity for the face only) of clear or almost clear (0 or 1) and time to achieve FsIGA of clear or almost clear (0 or 1). The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Time to Achieve F-VASI75
The time to achieve F-VASI75 50. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Achievement of Success in FsIGA Score
FsIGA of clear or almost clear (0 or 1) plus 2-grade improvement from baseline. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24
Time to PaGIC-V Score of Very Much Improved or Improved
The time to a PaGIC-V score of 1 'very much improved' or 2 'improved'. The PaGIC-V category, a 7-point scale comparing facial vitiligo at baseline with the subject's treated facial vitiligo at the study visit (with 1- very much improved and 7 - very much worse), and time to achieve a PaGIC-V of very much improved or much improved. The endpoint was not assessed due to early study termination.
Time frame: Week 4, 8, 12, 16, 20, and 24