A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
SAD part: A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3. MD part: In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin
Berlin, Germany
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs
Time frame: 3 months
Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs
Time frame: 3 months
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