A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
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|ClinicalTrials.gov Identifier: NCT02781311|
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alopecia||Drug: Setipiprant Drug: Placebo Drug: Finasteride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males|
|Actual Study Start Date :||July 14, 2016|
|Actual Primary Completion Date :||March 15, 2018|
|Actual Study Completion Date :||May 22, 2018|
Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Setipiprant tablets, orally, BID for 24 weeks.
Placebo Comparator: Placebo
Two placebo tablets BID at 12-hour intervals for 24 weeks.
Placebo tablets, orally, BID for 24 weeks.
Active Comparator: Finasteride
Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Finasteride tablet, orally, once daily for 24 weeks.
- Change From Baseline in Target Area Hair Count (TAHC) at Week 24 [ Time Frame: Baseline (Day 1) to Week 24 ]TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.
- Subject Self-Assessment (SSA) Score in Hair Growth at Week 24 [ Time Frame: Week 24 ]The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, -3=Greatly decreased, -2=Moderately decreased, -1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781311
|Study Director:||Joan-En Lin||Allergan|