Efficacy of a cosmetic phyto-caffeine shampoo in female androgenetic alopecia

G Ital Dermatol Venereol. 2020 Aug;155(4):492-499. doi: 10.23736/S0392-0488.18.05499-8. Epub 2018 Mar 6.


Background: Androgenetic alopecia (AGA) is the most common type of hair loss in both males as well as females, occurring in up to 57% of women by the age of 80 years. Androgenetic alopecia is associated with a high psychological burden and often results in substantially reduced quality of life, poor body image and low self-esteem, particularly in women. Caffeine-based products have shown promise, both in vitro and in vivo, as potential treatments for AGA. This study was performed to determine the efficacy of a phyto-caffeine-containing shampoo used over a 6-month period in female subjects with AGA.

Methods: This was a single-center, double-blind parallel trial in which female subjects with AGA were randomized to either a phyto-caffeine-containing shampoo or a control shampoo. The primary endpoint was the change from baseline in the number of hairs pulled in a hair pull test at 6 months. Hair loss intensity, hair strength, subject satisfaction and tolerability were also assessed.

Results: Subjects using the phyto-caffeine-containing shampoo had significantly fewer hairs pulled in a hair pull test at 6 months, compared with subjects using the control shampoo (-3.1 vs. -0.5 hairs; P<0.001). The majority of pre-specified secondary endpoints were also significantly improved for subjects using the phyto-caffeine-containing shampoo, compared with controls. Both products were very well tolerated.

Conclusions: Compared with a control shampoo, a phyto-caffeine-containing shampoo was more efficacious, with respect to the number of hairs being pulled out at 6 months, hair loss intensity and hair strength in subjects with AGA.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Alopecia / drug therapy*
  • Alopecia / pathology
  • Caffeine / administration & dosage*
  • Caffeine / adverse effects
  • Cosmetics / administration & dosage
  • Double-Blind Method
  • Female
  • Hair / pathology
  • Hair Preparations / administration & dosage*
  • Hair Preparations / adverse effects
  • Humans
  • Middle Aged
  • Treatment Outcome


  • Cosmetics
  • Hair Preparations
  • Caffeine