Safety and Efficacy of HST 001 in Male Pattern Hair Loss

Male Pattern Hair Loss Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Male Pattern Hair Loss

• NCT number: NCT04435847
• Study type: Interventional
• Source: Histogen
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2020
• Completion date: January 20, 2021