The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial. 60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion. The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair. The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
intradermal injection
intradermal injection
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, Germany
Bioskin GmbH
Hamburg, Germany
Scalp Hair Density
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
Time frame: 12 weeks
Proportion of Anagen Hairs (%)
Change from baseline in proportion of anagen hairs (%) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)
Time frame: From baseline to after 12 weeks treatment
Change in Proportion of Telogen Hairs (%)
Change from baseline in proportion of telogen hairs (%) on the scalp after 12 weeks of
Time frame: From baseline to after 12 weeks treatment
Anagen Hair Density
Change from baseline of anagen hair density (number of hairs per cm"2") on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.
Time frame: From baseline to after 12 weeks treatment
Change in Telogen Hair Density
Change from baseline of telogen hair density (number of hairs per cm2) on the scalp after 12 weeks of treatment. (Only data from subjects included in the PPS are reported.)
Time frame: From baseline to after 12 weeks treatment
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