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NCT04435847 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of HST 001 in Male Pattern Hair Loss
A Phase 1 study of Male Pattern Hair Loss, sponsored by Histogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04435847: Completed Phase 1 study of Male Pattern Hair Loss, sponsored by Histogen.
NCT04435847 is a Phase 1 study of Male Pattern Hair Loss that has completed, run by Histogen. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04435847, a Phase 1 study of Male Pattern Hair Loss, has completed, sponsored by Histogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Phosphate Buffered Saline
- BIOLOGICAL HST 001
Study Locations (1)
California
- California Dermatology & Clinical Research Institute - Encinitas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2021-01-20 |
| Phase | Phase 1 |
What the finished NCT04435847 record still lists
NCT04435847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Male Pattern Hair Loss appearing as the primary indexed condition, and to 2 interventions - of which Phosphate Buffered Saline is the first listed.
NCT04435847 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04435847 about?
NCT04435847 is a clinical study titled "Safety and Efficacy of HST 001 in Male Pattern Hair Loss". 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 bee...
What is the current status of trial NCT04435847?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-05-26. Estimated completion is 2021-01-20.
What conditions does trial NCT04435847 study?
This clinical trial studies the following conditions: Male Pattern Hair Loss.
What interventions are being tested in trial NCT04435847?
The interventions under investigation include: Phosphate Buffered Saline (OTHER), HST 001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04435847?
This trial is sponsored by Histogen, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04435847 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04435847's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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