- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435847
Safety and Efficacy of HST 001 in Male Pattern Hair Loss
March 17, 2021 updated by: Histogen
Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With 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 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Encinitas, California, United States, 92024
- California Dermatology & Clinical Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria
- Must be 25 to 55 years of age inclusive, at the time of signing the informed consent
- Should be in good general health with a healthy scalp with no cutaneous disorder determined by medical history or physical examination
- Are classified as III Vertex (3 Vertex), IV (4) and V (5) under the N H Classification for male pattern hair loss (MPHL). Subjects should have some thinning in both the vertex and temporal regions of the scalp
- Willing to maintain the same hair-style during the study period. No razor shaving of head (bald) prior to study start and throughout the study period
- Must be Male.
- Willing to have two dot tattoos of the scalp
- Willing to have an approximately 1.0 cm2 area of hairs clipped in the vertex region and 0.5 cm2 in one temporal recession area at each visit where macrophotography is conducted
- Willing to comply with scheduled 7 visits in 26 weeks (or screening in + 6 = 7 visits)
- Willing to continue normal hair care shampoo throughout the course of the study
- Willing to maintain the same hair care routine and forgo the use of new scalp products, throughout the study
- Willing to undergo routine venipuncture for safety laboratory testing as well as a blood spot test for Vitamin D level analysis
- Capable of giving informed consent
- Fluent and literate in English
- Able to follow instructions and likely to complete all study visits as assessed by investigator and staff
Exclusion Criteria
- History of keloid formation or significant hyperpigmentation
- History of other forms of hair loss - Alopecia areata, trichotillomania, scarring alopecia etc.
- History of acute or chronic illness that in the opinion of the investigator might confound the results of the study including some drug medications
- Active skin diseases (eczema, atopic dermatitis, psoriasis, skin cancer, sun-damaged skin with actinic keratosis on the scalp, etc.) in or around the area to be treated
- Routine use of prescription anti inflammatory medications, immunosuppressive drugs, or antihistamine medications
- Use of topical drugs or other cosmetics on the scalp
- Use of over the counter (OTC) or prescriptive topical hair treatments, including hair transplantation during the last 6 months
- Currently using a hair system or wig
- History of hair transplants or scalp reduction surgery
- History of allergy or intolerance to lidocaine and/or epinephrine
- Use of hair dye within 3 days of the treatments, otherwise, willing to maintain the same hair color for the study duration
- Current enrollment in an investigational drug or device study
- Has tattoos or scars in scalp that would interfere with visual assessment
- Is an employee of the investigator's site, and employee or representative of Histogen, investor, or a relative with one of the above
- Has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's involvement in the study
- Known allergy to rice
- Known allergy to bovine products
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HST 001
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.
|
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).
|
Placebo Comparator: Placebo - Phosphate Buffered Saline
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant assessment of procedural pain.
Time Frame: 26 Weeks
|
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.
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26 Weeks
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Participant assessment of pain or other treatment site responses.
Time Frame: 26 Weeks
|
Participant assessment of pain or other treatment site responses as captured on "Subject Self Assessment Questionnaire for Pain."
The number and percent of participants reporting each sensation will be collected.
|
26 Weeks
|
Adverse Events
Time Frame: 26 Weeks
|
Safety and tolerability of HST 001 by comparing adverse events to baseline
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26 Weeks
|
Serum collection for Anti-Drug Antibodies
Time Frame: 26 Weeks
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Serum collection for testing for Anti-Drug Antibodies
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26 Weeks
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Absolute change from baseline total hairs in the target area (TAHC) of the vertex.
Time Frame: 18 Weeks
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Absolute change from baseline total hairs in the target area (TAHC) of the vertexes measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).
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18 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change from baseline total TAHC of the right temporal region.
Time Frame: 18 Weeks
|
Absolute change from baseline total TAHC of the right temporal region as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).
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18 Weeks
|
Absolute change from baseline total TAHC in the vertex and right temporal areas.
Time Frame: 26 Weeks
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Absolute change from baseline total TAHC in the vertex and right temporal areas as measured by Canfield's HairMetrix macrophotography system at week 26 compared to week 0 (baseline).
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26 Weeks
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Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.
Time Frame: 26 Weeks
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Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0; and week 26 compared to week 0.
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26 Weeks
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Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.
Time Frame: 26 Weeks
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Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas derived from Canfield's HairMetrix system measurements at week 18 and week 26.
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26 Weeks
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Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.
Time Frame: 26 Weeks
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Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas (separately) comparing week 0 to week 18 and week 0 to week 26.
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26 Weeks
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Participant global assessment of hair growth.
Time Frame: 26 Weeks
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Participant global assessment of hair growth from global photos on the "Subject Self Assessment Questionnaire for Efficacy," patient reported outcome measure for hair growth.
Minimum score is 7 and Maximum score is 35.
Lower scores indicate a better outcome.
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26 Weeks
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Evaluating investigator global assessment of hair growth.
Time Frame: 26 Weeks
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Evaluating investigator global assessment of hair growth from global photos, captured on the "Global Assessment Likert scale for Hair Growth ."
Minimum score is -3 and Maximum score is +3.
Positive scores indicate a better outcome.
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26 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2020
Primary Completion (Actual)
November 11, 2020
Study Completion (Actual)
January 20, 2021
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HST 001-AES-003-HG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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