NCT01325350.

Methods	This was a randomised, double‐blind, placebo and active‐controlled study Setting Multicentre (2) USA and Germany Date of study June 2011 to July 2012 (6‐month duration)
Participants	306 women Age = 18 to 59 years Inclusion criteria Mild to moderate FPHL with ongoing hair loss for at least 1 year. Willingness to have micro‐dot‐tattoo applied to scalp. Willingness to maintain same hair style, length and hair colour during study. Exclusion criteria Drug or alcohol abuse within 12 months. Human immunodeficiency virus (HIV)‐positive. Received hair transplants or had scalp reductions. Use of hair weaves, hair extensions or wigs within 3 months. Oral or topical minoxidil treatment within 6 months. Application of topical steroids or nonsteroidal anti‐inflammatory drugs (NSAIDs) to scalp within 4 weeks. Randomised 306 participants were randomised (bimatoprost A = 61, bimatoprost B = 61, bimatoprost C = 61, bimatoprost vehicle = 61, minoxidil 2% = 62) Withdrawals/losses to follow‐up There were 49/306 (16.0%) withdrawals/losses to follow‐up: 6/61 (9.8%) bimatoprost A group, 5/61 (8.2%) bimatoprost B group, 17/61 (27.9%) bimatoprost C group, 9/61 (14.8%) bimatoprost vehicle group, 12/62 (19.4%) minoxidil 2% group. Adverse events: bimatoprost A (3), bimatoprost B (3), bimatoprost C (3), bimatoprost vehicle (1), minoxidil 2% (2). Pregnancy: bimatoprost A (0), bimatoprost B (0), bimatoprost C (1), bimatoprost vehicle (0), minoxidil 2% (1). Lost to follow‐up: bimatoprost A (1), bimatoprost B (0), bimatoprost C (5), bimatoprost vehicle (1), minoxidil 2% (5). Personal reasons: bimatoprost A (2), bimatoprost B (1), bimatoprost C (6), bimatoprost vehicle (5), minoxidil 2% (3). Withdrawal by participant: bimatoprost A (0), bimatoprost B (0), bimatoprost C (1), bimatoprost vehicle (1), minoxidil 2% (0). Did not receive treatment: bimatoprost A (0), bimatoprost B (1), bimatoprost C (1), bimatoprost vehicle (0), minoxidil 2% (1). Baseline data Target area hair count hairs/cm² (SD): bimatoprost 153.1 (54.78), bimatoprost B 161.1 (63.85), bimatoprost C 145.2 (63.42), bimatoprost vehicle 163.0 (57.28), minoxidil 2% 156.3 (55.46)
Interventions	Intervention Bimatoprost (formulation A) 1 mL/day once daily for 6 months. Comparator Bimatoprost (formulation B) 1 mL/day once daily for 6 months. Comparator 2 Bimatoprost (formulation C) 1 mL/day once daily for 6 months. Comparator 3 Bimatoprost vehicle 1 mL/day once daily for 6 months. Comparator 4 Minoxidil 2% 1 mL/day twice daily for 6 months.
Outcomes	Assessments (2): at baseline and month 6 Primary outcomes (as reported) Change from baseline in target area hair count.¹ Percentage of participants in each response category of the subject self assessment in alopecia (SSA) score.¹ Secondary outcomes (as reported) Percentage of participants in each response category of the Investigator Global Assessment (IGA) score.¹ Percentage of participants in each response category of the Global Panel Review (GPR) score.¹ Change from baseline in target area hair width (TAHW).¹ Change from baseline in target area hair darkness (TAHD). ¹Denotes outcomes prespecified for this review
Funding source	Sponsor is Allergan
Declaration of interest	No information, probably Allergan
Notes	We e‐mailed Allergan several times, without any response
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (clinicaltrials.gov): "randomized". Comment: the trial authors did not report the method used to generate the allocation sequence in sufficient detail to allow a clear assessment of whether it would produce comparable groups.
Allocation concealment (selection bias)	Unclear risk	The trial authors did not report the method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment. Comment: there was insufficient information to permit a clear judgement.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote (clinicaltrials.gov): "double‐blind". Comment: the report did not provide sufficient detail about the measures used to blind study participants and personnel from knowledge of which intervention a participant received, to permit a clear judgement.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote (clinicaltrials.gov): "double‐blind". Comment: there was uncertainty with effective blinding of outcomes assessors (healthcare providers) during the study. There was insufficient information to permit a clear judgement.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There were 49/306 (16.0%) withdrawals/losses to follow‐up: 6/61 (9.8%) bimatoprost A group, 5/61 (8.2%) bimatoprost B group, 17/61 (27.9%) bimatoprost C group, 9/61 (14.8%) bimatoprost vehicle group, 12/62 (19.4%) minoxidil 2% group. Reasons were reported, and there was an unbalanced number of drop‐outs. However, the higher percentage of drop‐outs in bimatoprost C group was unrelated to adverse events or lack of effect. Data analysis was per‐protocol. Comment: we judged this as at unclear risk of bias.
Selective reporting (reporting bias)	Low risk	The study protocol was available (NCT01325350 as well as EudraCT 2011‐000380‐27), and trial reported all outcomes listed. Comment: we judged this as at a low risk of bias.
Other bias	Low risk	Comment: the study appeared to be free of other forms of bias.