The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).
HSC consists of proteins secreted by human dermal cells under proprietary culture conditions that include reduced oxygen and bioreactors. Under these conditions, the cells secrete soluble proteins that include both growth factors and soluble precursors to the deposited extracellular matrix. Several of these proteins are known to be important in the control of the hair cycle and will stimulate resting hair follicles to resume hair formation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.
The Medical City
Pasig, Manila, Philippines
Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies)
Time frame: Clinically significant change from screening visit to Week 12
Non-vellus hair counts
Time frame: Change from Baseline to week 12 in treatment areas
Hair Thickness Density
Time frame: Change from Baseline to week 48 in treatment areas
Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events
Time frame: Clinically significant change from Screening visit to Week 48
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