A Multicenter, Randomized, Placebo-Controlled Double-Blind Clinical Trial of a Novel Formulation of 5% Topical Minoxidil
Foam vs. Placebo in the Treatment of Androgenetic Alopecia in Men
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Πηγή]
Olsen, Elise;1 Funicella, Toni;2 Roberts, Janet;3 Kempers, Steven;4
Piacquadio, Dan;5 Wanser, Rita;6 Zhang, Paul;6 Kohut, Bruce;6
1. Duke University Medical Center, Durham, Northe
CArolina, USA; 2. DermResearch, Inc., Austin, TX, USA;
3. Northwest Cutaneous Research Specialists, Portland, OR,
USA; 4. Minnesota Clinical Study Center, Fridley, MN, USA;
5. Therapeutics, Inc., Lajolla, CA, USA; 6. McNeil Consumer
Healthcare, Morris Plains, NJ, USA
Although 5% topical minoxidil solution is safe and effective,a vehicle that does not contain propylene glycol and is more
aesthetically pleasing to the consumer, would be a distinct advantage to consumers for use in androgenetic alopecia
(AGA).Objective: To assess the efficacy and safety of 5% topical minoxidil when formulated in a new foam vehicle (TMF)
for men with AGA.
Method: Two-phase study:
• Sixteen week double-blind placebo-controlled phase to evaluate the efficacy and safety of the 5% TMF.
This phase was conducted on 352 men ages 20-49 with patterns IIIv, IV or V Hamilton Norwood with the primary
efficacy endpoints of change between Baseline and Week 16 target area hair counts (TAHC) and Week 16 subject
assessment of change in hair loss condition from Baseline.
• Open-label extension phase to collect 52 weeks of safety data with 5% TMF. One hundred forty-three
subjects continued on this phase of the study. Safety was monitored by taking intercurrent history, vital signs
and scalp irritation assessment by both investigator and subject.
Results:
• Statistically significant increase at Week 16 compared to Baseline in TAHC with the 5% TMF group (170.8 to 190.8 hairs) compared to placebo (168.9 to 174.4) (p<0.0001).
• Statistically significant subjective assessment of hair loss condition (p<0.0001) on 5% TMF (70.6% noted increased
hair growth, including 47.8% moderate or marked hair growth) compared to placebo (42.4% noted increased
hair growth, including 21.5% moderate or marked hair growth).
• No significant safety concerns were raised and the 5% TMF was well tolerated over a one year use period.
Conclusions: The 5% topical minoxidil product, formulated without propylene glycol and in a foam vehicle, is a safe and
effective treatment for men with AGA.
Έρευνα χρήσης τοπικής μινοξιδίλης σε υγρή μορφή, 2 & 3%.
Use of topical minoxidil in the treatment of male pattern baldness.Savin RC.
This 12-month, double-blind, randomized study evaluated the safety and efficacy of topical minoxidil in the treatment of male pattern baldness. Three formulations were compared: 2% minoxidil solution, 3% minoxidil solution, and placebo. After 4 months all placebo patients crossed over to treatment with the 3% solution. Of the 96 patients randomized into the study, 79 were evaluable at month 12; 25 of these were in the 2% minoxidil group, 24 were in the 3% minoxidil group, and 29 were in the placebo-to-3% solution switchover group. At monthly intervals a hair count was obtained within a 1-inch diameter area on the scalp vertex. In addition, a gross visual estimate of the degree of new hair growth over the entire balding area was made independently by the investigator and the patient. At the end of 4 months there was significant regrowth of nonvellus (terminal and indeterminate) hairs in the patients using the 2% and 3% solutions (p = 0.0001). The mean nonvellus hair count at month 4 was 162.8 in the 2% minoxidil group, 155.4 in the 3% minoxidil group, and 107.1 in the placebo group. The mean increase in the 2% and 3% treatment groups was 58.2 and 48.8, respectively, whereas the mean increase in the placebo group was 4.0. Total hair counts at month 4 demonstrated significantly more growth of hair in the 2% minoxidil group than in the placebo group (p = 0.013), with no significant difference between the 3% minoxidil group and the other two treatment groups.
