A randomized clinical trial of 5%
topical minoxidil versus 2% topical minoxidil and
placebo in the treatment of androgenetic alopecia in
men.
Set 2002
Olsen EA, Dunlap FE, Funicella T, Koperski JA,
Swinehart JM, Tschen EH, Trancik RJ.
Duke Dermatopharmacology Study Center, Durham, North
Carolina, USA.
BACKGROUND: Topical minoxidil solution 2% stimulates new
hair growth and helps stop the loss of hair in
individuals with androgenetic alopecia (AGA).
Results can be variable, and historical experience
suggests that higher concentrations of topical minoxidil
may enhance efficacy.
OBJECTIVE: The purpose of this 48-week, double-blind,
placebo-controlled, randomized, multicenter trial was to
compare 5% topical minoxidil with 2% topical minoxidil
and placebo in the treatment of men with AGA.
METHODS: A total of 393 men (18-49 years old) with
AGA applied 5% topical minoxidil solution (n = 157), 2%
topical minoxidil solution (n = 158), or placebo
(vehicle for 5% solution; n = 78) twice daily.
Efficacy was evaluated by scalp target area hair
counts and patient and investigator assessments of
change in scalp coverage and benefit of treatment.
RESULTS: After 48 weeks of therapy, 5% topical
minoxidil was significantly superior to 2% topical
minoxidil and placebo in terms of change from baseline
in nonvellus hair count, patient rating of scalp
coverage and treatment benefit, and investigator rating
of scalp coverage.
Hair count data indicate that response to treatment
occurred earlier with 5% compared with 2% topical
minoxidil. Additionally, data from a patient
questionnaire on quality of life, global benefit, hair
growth, and hair styling demonstrated that 5% topical
minoxidil helped improve patients' psychosocial
perceptions of hair loss.
An increased occurrence of pruritus and local
irritation was observed with 5% topical minoxidil
compared with 2% topical minoxidil.
CONCLUSION: In men with AGA, 5% topical minoxidil was
clearly superior to 2% topical minoxidil and placebo in
increasing hair regrowth, and the magnitude of its
effect was marked (45% more hair regrowth than 2%
topical minoxidil at week 48).
Men who used 5% topical minoxidil also had an earlier
response to treatment than those who used 2% topical
minoxidil. Psychosocial perceptions of hair loss in men
with AGA were also improved.
Topical minoxidil (5% and 2%) was well tolerated by
the men in this trial without evidence of systemic
effects.
Publication Types:
- Clinical Trial
- Multicenter Study
- Randomized Controlled Trial
PMID: 12196747 [PubMed - indexed for MEDLINE]
