DeVillez 1994.

Methods	This was a randomised, double‐blind, placebo‐controlled trial Setting Multicentre (11), USA, but no further details reported Date of study Unspecified (32‐week duration)
Participants	308 women Mean age (SD) = 33.6 years (6.67) in the minoxidil group, 34.4 years (6.32) in the placebo group Inclusion criteria Age 18 to 45 years. FPHL Ludwig scale grade I or II (Ludwig 1977). Good general health; no evidence of cardiac, systemic, psychiatric, or scalp disease. Exclusion criteria Previous exposure to minoxidil solution. Pregnant or at risk of pregnancy, < 12 months postpartum, or breast feeding. Prior use of hair restorers or systemic drugs, e.g. steroids, antihypertensives, cytotoxic compounds, vasodilators, anticonvulsant drugs, ß‐blockers, spironolactone, cimetidine, diazoxide, cyclosporin, ketoconazole, cyproterone acetate, oestrogens, or progesterones, in previous 3 months. Randomised 308 participants were randomised (minoxidil group = 157, placebo group = 151) Withdrawals/losses to follow‐up There were 52/308 (17%) withdrawals/losses to follow‐up: 27/157 (16.6%) in the minoxidil group, and 25/151 (14.8%) in the placebo group Voluntary withdrawal: minoxidil group = 18 (11.5%), placebo group = 17 (11.3%). Local irritation: minoxidil group = 1 (0.1%), placebo group = 1 (0.1%). Pregnancy: minoxidil group = 2, placebo group = 0. Other health problems: minoxidil group = 6 (3.8%), placebo group = 6 (3.3%). Use of prohibited medication: minoxidil group = 0, placebo group = 1. Baseline data Duration of hair loss (SD): minoxidil group = 9.5 years (6.67), placebo group = 9.0 years (6.68) Age at onset (SD) : minoxidil group = 24.1 years (7.26), placebo group = 25.4 years (7.14) Degree of thinning, Ludwig scale (% of participants by grade and group) Grade I: minoxidil group = 48, placebo group = 53. Grade II: minoxidil group = 52, placebo group = 47.
Interventions	Intervention Minoxidil 2% topical solution (minoxidil powder, propylene glycol, alcohol, and water). Applied 1 mL twice daily at 12 hour‐intervals to the scalp for 32 weeks. Comparator Placebo (propylene glycol, alcohol and water). Applied 1 mL twice daily at 12 hour‐intervals to the scalp for 32 weeks.
Outcomes	Assessments (9): at baseline and every 4 weeks Primary outcomes (as reported) Hair counts (combination photography and computer‐assisted image counting).¹ Secondary outcomes (as reported) Investigator‐ and participant‐assessed new hair growth, rated as none/minimal or moderate/dense compared to baseline.¹ Participant‐assessed hair shedding (degree), rated as increased/decreased/unchanged.¹ Adverse events.¹ ¹Denotes outcomes prespecified for this review
Funding source	The report was unclear about the extent and level of any funding or support, but as three of the investigators were employed by the manufacturer, a level of support and possibly funding is most probable.
Declaration of interest	Three of the four investigators were from the Dermatology Division of Upjohn Laboratories, the manufacturer of the intervention under investigation
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote (page 304): "randomized to receive either". 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 (page 304): "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 (page 304): "Both the investigator and the patient assessed visible new hair growth." Comment: there was uncertainty with effective blinding of outcomes assessors (participants/healthcare providers) during the study. There was insufficient information to permit a clear judgement.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	52/308 participants "discontinued"; most were voluntary withdrawals and were balanced across both groups. The data analysis was per‐protocol. Comment: the number of dropouts (17%) and incomplete outcome data, combined with per‐protocol analysis were potential sources of bias.
Selective reporting (reporting bias)	Low risk	The protocol for the study was unavailable, but the prespecified outcomes and those mentioned in the methods section appeared to have been reported. 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.