Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study

J Drugs Dermatol. 2016 Jul 1;15(7):883-9.

Abstract

Background: A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss.<br/>

Objective: Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks.

Methods: In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.<br/>

Results: Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm<sup>2</sup> at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm<sup>2</sup> at week 24. The treatment difference was -0.3 hairs/cm<sup>2</sup> (95% CI = -6.0, 5.4). Since the lower bound of the 95% CI was less than -5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.<br/>

Conclusions: Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.<br /> ClinicalTrials.gov identifier: NCT01145625 <br /><br /> <em>J Drugs Dermatol.</em> 2016;15(7):883-889.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Alopecia / diagnosis*
  • Alopecia / drug therapy*
  • Dermatitis, Irritant / diagnosis
  • Dermatitis, Irritant / etiology
  • Drug Administration Schedule
  • Drug Compounding
  • Female
  • Humans
  • Middle Aged
  • Minoxidil / administration & dosage*
  • Minoxidil / adverse effects
  • Minoxidil / chemistry*
  • Pharmaceutical Solutions / administration & dosage
  • Pharmaceutical Solutions / adverse effects
  • Pharmaceutical Solutions / chemistry
  • Single-Blind Method
  • Treatment Outcome

Substances

  • Pharmaceutical Solutions
  • Minoxidil

Associated data

  • ClinicalTrials.gov/NCT01145625