Trial · NCT02781311

A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

NCT02781311, Phase 2, Completed, Allergan; results first posted 2019-04-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males. Trials, record NCT02781311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02781311

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
NCT number: NCT02781311
Status: Completed
Phases: Phase 2
Enrollment: 169 participants, actual
Lead sponsor: Allergan
Conditions: Alopecia
Interventions: Setipiprant, Placebo, Finasteride
First posted: 2016-05-24
Last updated: 2019-04-05
Results first posted: 2019-04-05
Limitations and caveats: Due to change in planned analysis, data of participants in the finasteride arm group were not included in the efficacy analysis.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Target Area Hair Count (TAHC) at Week 24	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.
Primary	Subject Self-Assessment (SSA) Score in Hair Growth at Week 24	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Target Area Hair Count (TAHC) at Week 24	Baseline (Day 1) to Week 24	mITT population included all randomized participants who received study intervention and had a baseline and at least 1 postbaseline measurement for 1 of the coprimary efficacy measures. As per protocol Amendment 1, Finasteride arm group was not included in the analysis model. Number analyzed is participants with data available for analysis.	terminal hairs/cm^2	LEAST_SQUARES_MEAN
PRIMARY	Subject Self-Assessment (SSA) Score in Hair Growth at Week 24	Week 24	mITT population included all randomized participants who received study intervention and had a baseline and at least 1 postbaseline measurement for 1 of the coprimary efficacy measures. As per protocol Amendment 1, Finasteride arm group was not included in the analysis model. Number analyzed is participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Target Area Hair Count (TAHC) at Week 24	Placebo	6.7	Standard Error 3.25	terminal hairs/cm^2
Change From Baseline in Target Area Hair Count (TAHC) at Week 24	Setipiprant	7.1	Standard Error 3.03	terminal hairs/cm^2
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24	Placebo	-0.2	Standard Error 0.15	score on a scale
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24	Setipiprant	-0.3	Standard Error 0.14	score on a scale

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	74
Overall Study	STARTED	Setipiprant	83
Overall Study	STARTED	Finasteride	12
Overall Study	Safety Population (Treated)	Placebo	73
Overall Study	Safety Population (Treated)	Setipiprant	81
Overall Study	Safety Population (Treated)	Finasteride	12
Overall Study	mITT Population	Placebo	70
Overall Study	mITT Population	Setipiprant	78
Overall Study	mITT Population	Finasteride	11
Overall Study	COMPLETED	Placebo	48

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events105

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Libido decreased	Psychiatric disorders	Placebo	0	73
other	Libido decreased	Psychiatric disorders	Setipiprant	0	81
other	Libido decreased	Psychiatric disorders	Finasteride	2	12
other	Upper respiratory tract infection	Infections and infestations	Placebo	0	73
other	Upper respiratory tract infection	Infections and infestations	Setipiprant	6	81
other	Upper respiratory tract infection	Infections and infestations	Finasteride	2	12
other	Agitation	Psychiatric disorders	Placebo	0	73
other	Agitation	Psychiatric disorders	Setipiprant	0	81
other	Agitation	Psychiatric disorders	Finasteride	1	12
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	0	73

1 to 10 of 105Source ClinicalTrials.gov

See all 105 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	73
Total, all-cause mortality	Setipiprant	0	81
Total, all-cause mortality	Finasteride	0	12
Total, other adverse events	Placebo	26	73
Total, other adverse events	Setipiprant	28	81
Total, other adverse events	Finasteride	6	12
Total, serious adverse events	Placebo	2	73
Total, serious adverse events	Setipiprant	0	81
Total, serious adverse events	Finasteride	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02781311

GET https://conductscience.org/api/trials/v1/NCT02781311/events?page=2

API reference For AI assistants