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

Keene 2011.

Methods This was a randomised, blinded, sham‐controlled trial
Setting
Unspecified USA
Date of study
December 2008 to December 2009 (6‐month duration)
Participants 13 women
Mean age (SD) = not reported
Inclusion criteria
  • Postmenopausal women with frontal or vertex hair loss.


Exclusion criteria
  • Active depression.

  • Hair loss caused by metabolic or hormonal abnormalities.

  • Hair loss because of medication or other dermatologic conditions that were not apparently androgenetic alopecia (AGA), including diffuse unpatterned hair loss.


Randomised
13 participants were randomised (finasteride group = 8, placebo group = 5)
Withdrawals/losses to follow‐up
None were reported
Baseline data
None reported
Interventions Intervention
  • Finasteride 1 mg for 6 months.


Comparator
  • Placebo for 6 months.

Outcomes Assessments (7): at baseline and every month
Outcomes of the trial (as reported)
  • Hair counts (two 1 cm2 areas along the leading edge of hair loss which were tattooed for reproducible reference Microphotographs were then taken using a Nikon D80, Speedlight600 camera, 10.2 megapixels, with a Dermlite lens and Global photographs were taken using a Nikon Coolpix 995, 3.24‐megapixel digital camera (Nikon Corporation, Shinjuku, Tokyo, Japan).¹

  • Beck Depression Inventory survey.


¹Denotes outcomes prespecified for this review
Funding source Quote (page 268): "study was funded by DermaGenoma, Inc"
Declaration of interest Quote (page 268): "Both authors are employed by DermaGenoma, Inc"
Notes Study participants used buccal swabs to obtain DNA for identification of their AR gene polymorphism. This involved evaluation of the number of CAG nucleotide repeats in the first exon of the AR gene in each X chromosome. Subsequently, each participant who was not homozygous in the AR‐CAG allele underwent determination of percentage of X inactivation for each allele based on the method of quantitative polymerase chain reaction (PCR) product (inactive allele) following digestion of unmethylated (activated) DNA
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (page 297): "Patients who met the inclusion criteria were randomized to either placebo or 1‐mg finasteride".
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.
After e‐mail communication: "For each subject, the site supervisor picked from a bowl a random letter A or B".
Comment: this was probably done.
Allocation concealment (selection bias) Low risk 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, was not reported.
 Comment: there was insufficient information to permit a clear judgement.
After e‐mail communication: "The study was conducted for a sponsor. The sponsor recruited an independent site monitor (Registered Nurse) who had the sole access to the information during the course of the study".
Comment: this is a form of central allocation, which was probably done.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote (page 297): "6‐month blinded".
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.
After e‐mail communication: "Tablets were compounded at a pharmacy to look exactly the same".
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote (page 297): "6‐month blinded".
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.
After e‐mail communication: "Tablets were compounded at a pharmacy to look exactly the same".
Comment: it was unlikely that the blinding was broken.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts were reported and data are available for all individual participants.
 Comment: we judged this as at low risk of bias.
Selective reporting (reporting bias) Low risk The protocol for the study was available on clinicaltrials.gov (NCT01052870). The trial appeared to report 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.