Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
360
Trial Sponsor
Clinical Trial Start Date
May 26, 2020
0Primary Completion Date
November 11, 2020
0Study Completion Date
January 20, 2021
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Other0
Biological0
Intervention Name
Phosphate Buffered Saline0
HST 0010
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With Male Pattern Hair Loss0
Last Updated
March 19, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Triple0
Masked Party
Care Provider0
Participant0
Outcomes Assessor0
Study 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
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
