NCT04435847

Safety and Efficacy of HST 001 in Male Pattern Hair Loss

Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With Male Pattern Hair Loss

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Histogen · Industry
• Sex: Male
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Male Pattern Hair Loss

Interventions

Type	Name	Description
BIOLOGICAL	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 active treatment (HST 001).
OTHER	Phosphate Buffered Saline	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).

Timeline

• Start date: 2020-05-26
• Primary completion: 2020-11-11
• Completion: 2021-01-20
• First posted: 2020-06-17
• Last updated: 2021-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study