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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 is a Phase 1 study of Male Pattern Hair Loss that has completed, run by Histogen. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04435847
The ClinicalTrials.gov registry entry for NCT04435847 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Histogen, which has 4 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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