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. 2016 May 26;2016(5):CD007628. doi: 10.1002/14651858.CD007628.pub4

Price 1990.

Methods This was a randomised, double‐blind, placebo‐controlled trial
Setting
Departments of Dematology of Kaiser Permanente Medical Center and University, San Francisco, and Trichos Research, Richmond, USA
Date of study
Unreported (40‐week duration)
Participants 9 women
Age = 22 to 41 years
Inclusion criteria
  • Female 18 to 45 years.

  • Ludwig scale grade I and II (Ludwig 1977).

  • Good health.

  • Regular menses.

  • Dark undyed hair.


Exclusion criteria
  • Pregnancy.

  • < 12 months postpartum or breastfeeding.

  • Previous use of topical minoxidil.

  • < 3 months before start of study use of the following: oral contraceptives, steroid hormones, vasodilators, antihypertensives, anticonvulsants, cytotoxic agents, ß‐blockers, spironolactone, cimetidine, cyclosporin, ketoconazole, or hair restorers.


Randomised
9 participants were randomised (minoxidil group = 5, placebo group = 4)
Withdrawals/losses to follow‐up
There was 1 withdrawal in the minoxidil group due to hyperprolactinaemia
Baseline data
Degree of thinning Ludwig scale (participants by grade, intervention group)
  • Grade I: minoxidil group = 2, placebo group = 1.

  • Grade II: minoxidil group = 3, placebo group = 3.

Interventions Intervention
  • Minoxidil 2% solution. 1 mL of solution twice daily on scalp (frontal parietal) at clipped site over 32 weeks.


Comparator
  • Vehicle solution. 1 mL of solution twice daily on scalp (frontal parietal) at clipped site over 32 weeks.


The study duration was 40 weeks, and treatment was started after the 2nd visit at 4 weeks from baseline
Outcomes Assessments (6): at baseline and at 8‐week intervals
Outcomes (as reported)
  • Hair weight of clipped sample.

  • Hair count of clipped sample.¹

  • Hair width/length of clipped sample.


¹Denotes outcomes prespecified for this review
Funding source Quote (page 683): "The Upjohn Company provided support and encouragement of this research."
Declaration of interest None declared
Notes Individual patient data were reported, but there were small sample sizes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (page 684): "The subjects were given test solutions in a random, double‐blind manner."
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 of risk of bias.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote (page 683): "double‐blind protocol".
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 of risk of bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk There was insufficient information to permit a clear judgement of the risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There was a small number of withdrawals: 1/9 in the minoxidil group (hyperprolactinaemia).
Individual patient data were reported.
Comment: we judged this as at a low risk of bias.
Selective reporting (reporting bias) Low risk The protocol for the study was unavailable, but the trial appears to have reported the prespecified outcomes and those mentioned in the methods section.
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.