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
* 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
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).
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Participant assessment of procedural pain.
Participant assessment of procedural pain as captured on the "Subject Self Assessment Questionnaire for Pain." Minimum score is 1, Maximum score is 5, higher score means worse outcome.
Time frame: 26 Weeks
Participant assessment of pain or other treatment site responses.
Participant assessment of pain or other treatment site responses as captured on "Subject Self Assessment Questionnaire for Pain." The number and percent of participants reporting each sensation will be collected.
Time frame: 26 Weeks
Adverse Events
Safety and tolerability of HST 001 by comparing adverse events to baseline
Time frame: 26 Weeks
Serum collection for Anti-Drug Antibodies
Serum collection for testing for Anti-Drug Antibodies
Time frame: 26 Weeks
Absolute change from baseline total hairs in the target area (TAHC) of the vertex.
Absolute change from baseline total hairs in the target area (TAHC) of the vertexes measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).
Time frame: 18 Weeks
Absolute change from baseline total TAHC of the right temporal region.
Absolute change from baseline total TAHC of the right temporal region as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).
Time frame: 18 Weeks
Absolute change from baseline total TAHC in the vertex and right temporal areas.
Absolute change from baseline total TAHC in the vertex and right temporal areas as measured by Canfield's HairMetrix macrophotography system at week 26 compared to week 0 (baseline).
Time frame: 26 Weeks
Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.
Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0; and week 26 compared to week 0.
Time frame: 26 Weeks
Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.
Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas derived from Canfield's HairMetrix system measurements at week 18 and week 26.
Time frame: 26 Weeks
Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.
Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas (separately) comparing week 0 to week 18 and week 0 to week 26.
Time frame: 26 Weeks
Participant global assessment of hair growth.
Participant global assessment of hair growth from global photos on the "Subject Self Assessment Questionnaire for Efficacy," patient reported outcome measure for hair growth. Minimum score is 7 and Maximum score is 35. Lower scores indicate a better outcome.
Time frame: 26 Weeks
Evaluating investigator global assessment of hair growth.
Evaluating investigator global assessment of hair growth from global photos, captured on the "Global Assessment Likert scale for Hair Growth ." Minimum score is -3 and Maximum score is +3. Positive scores indicate a better outcome.
Time frame: 26 Weeks
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