Safety and Efficacy of HST 001 in Male Pattern Hair Loss
Condition: Male Pattern Hair Loss
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      HST 001 (also known as hair stimulating complex [HSC]) is a mixture of growth factors
      secreted by human dermal fibroblasts when cultured in proprietary bioreactors which are then
      harvested and concentrated to specific ranges. In both preclinical studies and in previous
      clinical trials, HSC has been shown to be safe, with no serious adverse events reported. This
      protocol design is based on the completed Phase 1 study in women which used a similar
      investigational product (Study 16-HIS002-US; HSC660), and includes specific objective
      efficacy endpoints (macrophotography) to measure Target Area Hair Counts (TAHC) after three
      separate doses of product separated by six weeks (week 0, week 6, week 12) and comparing to
      placebo treated group
    

Detailed description: 
      -  Single center, randomized, controlled, parallel-design study in participants with mild
           to moderate hair loss on a Norwood-Hamilton (N-H) Scale

        -  Double-blind: Evaluating Investigator (EI) and participants are blinded; Treating
           Investigator (TI) is not blinded

        -  Investigational product is randomly assigned to subjects upon enrollment and will
           receive either HST 001 or placebo (phosphate buffered saline [PBS]). Injections will be
           delivered via 1 mL syringes with 31 Gauge needles to the target depth of 1.75 mm, using
           a slow injection technique and holding the needle in position for count of 3-4 seconds.
           Each injection will provide 0.1 mL and a total of 20 injections will be given in the
           scalp with particular attention to the leading edge of the vertex and the temporal
           recession areas

        -  Participants will receive intradermal injections at 3 timepoints only: week 0, week 6
           and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20
           injections spaced approximately 0.8 - 1.2 cm apart from one another. Dosing will be
           split between the leading edge of the vertex region (~10 injections covering 10.18 cm2)
           and in each temporal recession area (~5 injections covering 7.07cm2) in each.

        -  Adverse Events (AEs) will be monitored to ensure safety of participants throughout the
           study

        -  Efficacy will be assessed at Week 18 and Week 26 via macrophotography and TAHC by the
           Canfield HairMetrix System
    

Intervention name(s): HST 001; Phosphate Buffered Saline
Intervention type(s): Biological; Other
Intervention description(s): Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of active treatment (HST 001).; Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of placebo control (Phosphate Buffered Saline).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment