REGAINE® Foam provides significant increases in hair growth vs. placebo1

In a multi-centre, randomized, double-blind clinical trial of REGAINE® foam versus placebo in the treatment of male androgenetic alopecia:

  • Significant increase in hair counts after recommended minimum period of use of 16 weeks
  • Over 4 times more hair regrowth than with the placebo, (respectively 20.9 vs. 4.7 increase over baseline)
  • 9 out of 10 men said they kept or regrew their hair after 16 weeks of using twice daily.1

Hair growth graph

Adapted from Olsen EA et al 2007.1

REGAINE® for men pivotal trial

A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men
Olsen EA et al. J Am Acad Dermatol 2007; 57: 767-74.

OBJECTIVE:
To assess the efficacy and safety of REGAINE® Foam (5% minoxidil topical formulation in a propylene glycol-free foam vehicle) in men with androgenetic alopecia, a 16-week, double-blind, multi-centre, randomized, placebo-controlled trial was undertaken in 352 subjects, aged 18 to 49 years old.

METHODS:
The mean age of enrolled subjects was 39.2 years old. Forty percent of subjects had type IIlv, 33% had type IV, and 27% had type V Hamilton-Nolwood hair loss pattern. Efficacy was evaluated by Target Area Hair Counts (TAHC) on the anterior leading edge of the vertex balding scalp at baseline and weeks 8,12 and 16. The other co-primary endpoint was subject assessment of improvement by questionnaire at week 16. At week 16, 143 subjects continued on an open-label phase to collect 52 weeks of safety information on 5% minoxidil topical foam.

RESULTS:
There was a steady increase in TAHCs over the 16-week, double-blind phase in subjects on REGAINE® Foam. The mean change in TAHC at weeks 8, 12, and 16 was significantly greater for the REGAINE® Foam group as compared to placebo at all time points (P < .0001 for each).

Overall, following 16 weeks on REGAINE® Foam, there was a mean 13.4% increase in TAHC over baseline; the placebo group showed a 3.4% increase.

There was a statistically significant difference between REGAINE® Foam and placebo (P < .0001) for subject assessment of improvement of hair loss condition. Of subjects on REGAINE® Foam, 70.6% felt their hair loss had improved from baseline and only 6.2% felt that it had worsened. 88.4% of subjects on REGAINE® Foam reported that they kept or regrew their hair.

In comparison, 42.4% of subjects on placebo felt their hair loss had improved from baseline, and 19.2% of subjects felt their hair loss had worsened. The REGAINE® Foam was well tolerated over a 52-week period.

CONCLUSION:
“We believe that [REGAINE® Foam] is an effective treatment for men with androgenetic alopecia.”

Click through to Pubmed http://www.ncbi.nlm.nih.gov/pubmed/17761356

  • Olsen EA et al. J Am Acad Dermatol 2007; 57: 767-74.