Efficacy and Safety of Minoxidil 5% Foam in Combination With a Botanical Hair Solution in Men With Androgenic Alopecia

J Drugs Dermatol. 2016 Apr;15(4):406-12.

Abstract

Androgenic alopecia (AGA) is the most common type of hair loss in men, characterized by hair miniaturization, hairline recession, and vertex balding. It affects approximately 50% of men, negatively affecting self-esteem and sociability. Topical minoxidil formulations are approved up to a 5% concentration for men, but patient adherence to treatment is challenged by gradual results that may be perceived as a lack of initial benefit. Herbal extracts, which are also believed to promote healthier-looking hair, have a long history of use in hair care formulations. The safety and efficacy of a twice-daily regimen of 5% minoxidil foam used in combination with a novel botanical hair solution was evaluated in a 12-week, multicenter, single-arm, open label study in 56 subjects with mild to moderate AGA. Assessments included investigator ratings of improvement and subject self-ratings of satisfaction. Investigator ratings indicated significant improvement in scalp hair coverage and perception of overall treatment benefit in as early as 4 weeks (P<.001). Subject self-ratings were significant for improved hair growth and hair appearance in as few as 4 weeks (P<.05). The regimen was well tolerated, and subjects indicated a high degree of satisfaction. Investigator and subject-assessed efficacy and subject satisfaction with this novel regimen provide clinicians with an effective treatment option for AGA that also provides a high level of patient satisfaction, which may help promote patient adherence to long-term treatment.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Alopecia / diagnosis*
  • Alopecia / drug therapy*
  • Drug Compounding
  • Drug Therapy, Combination
  • Hair Preparations / administration & dosage*
  • Hair Preparations / chemistry
  • Humans
  • Male
  • Middle Aged
  • Minoxidil / administration & dosage*
  • Minoxidil / chemistry
  • Patient Satisfaction*
  • Pharmaceutical Solutions / administration & dosage
  • Pharmaceutical Solutions / chemistry
  • Plant Extracts / administration & dosage*
  • Plant Extracts / chemistry
  • Treatment Outcome
  • Young Adult

Substances

  • Hair Preparations
  • Pharmaceutical Solutions
  • Plant Extracts
  • Minoxidil