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
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.
http://www.nahrsmemb
Controlled Double-Blind Clinical Trial of a
Novel Formulation of 5% Topical Minoxidil
Foam vs. Placebo in the Treatment of
Androgenetic Alopecia in Men
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.
http://www.nahrsmemb