Male Pattern Hair LossPhase 1NCT04435847
Safety and Efficacy of HST 001 in Male Pattern Hair Loss
A Phase 1 study testing HST 001 and Phosphate Buffered Saline in people with Male Pattern Hair Loss, run by Histogen at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Pattern Hair Loss
- What is being tested?
- HST 001 and Phosphate Buffered Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2020to 20 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
About this study
Official title: 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
Read the 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
- Conditions
- Male Pattern Hair Loss
- Being tested
- HST 001, Phosphate Buffered Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HST 001Biological
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).
Phosphate Buffered SalineOther
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).
| Study group | Role | What they receive |
|---|---|---|
| HST 001 | Experimental | 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. Receives: Biological: HST 001 |
| Placebo - Phosphate Buffered Saline | Placebo comparator | Phosphate Buffered Saline Receives: Other: Phosphate Buffered Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant assessment of procedural pain.
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.
Measured: 26 Weeks
Participant assessment of pain or other treatment site responses.
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.
Measured: 26 Weeks
Adverse Events
Safety and tolerability of HST 001 by comparing adverse events to baseline
Measured: 26 Weeks
Serum collection for Anti-Drug Antibodies
Serum collection for testing for Anti-Drug Antibodies
Measured: 26 Weeks
Absolute change from baseline total hairs in the target area (TAHC) of the vertex.
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).
Measured: 18 Weeks
Secondary outcomes (7)
Absolute change from baseline total TAHC of the right temporal region.
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).
Measured: 18 Weeks
Absolute change from baseline total TAHC in the vertex and right temporal areas.
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).
Measured: 26 Weeks
Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.
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.
Measured: 26 Weeks
Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.
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.
Measured: 26 Weeks
Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.
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.
Measured: 26 Weeks
Participant global assessment of hair growth.
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.
Measured: 26 Weeks
Evaluating investigator global assessment of hair growth.
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.
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start26 May 2020
- Primary completion11 Nov 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Pattern Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Histogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435847
- Sponsor's protocol ID
- HST 001-AES-003-HG
- Status last verified
- Aug 2020
- First submitted
- 26 May 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With Male Pattern Hair Loss
- ClinicalTrials.gov ID
- NCT04435847
- Acronym / sponsor ID
- HST 001-AES-003-HG
- Conditions
- Male Pattern Hair Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HistogenIndustry (pharma, biotech, devices)
- Study start
- 26 May 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HST 001 | Experimental | Biological: HST 001HST 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. |
| Placebo - Phosphate Buffered Saline | Placebo comparator | Other: Phosphate Buffered SalinePhosphate Buffered Saline |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HST 001Participants 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). | Biological | HST 001 |
| Phosphate Buffered SalineParticipants 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). | Other | Placebo - Phosphate Buffered Saline |
Primary outcome
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.
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.
Adverse Events
Time frame: 26 Weeks
Safety and tolerability of HST 001 by comparing adverse events to baseline
Serum collection for Anti-Drug Antibodies
Time frame: 26 Weeks
Serum collection for testing for Anti-Drug Antibodies
Absolute change from baseline total hairs in the target area (TAHC) of the vertex.
Time frame: 18 Weeks
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).
7 secondary outcomes
Absolute change from baseline total TAHC of the right temporal region.
Time frame: 18 Weeks
Absolute change from baseline total TAHC in the vertex and right temporal areas.
Time frame: 26 Weeks
Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.
Time frame: 26 Weeks
Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.
Time frame: 26 Weeks
Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.
Time frame: 26 Weeks
Participant global assessment of hair growth.
Time frame: 26 Weeks
Evaluating investigator global assessment of hair growth.
Time frame: 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HST 001 and Phosphate Buffered Saline in people with Male Pattern Hair Loss, run by Histogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant assessment of procedural pain. (time frame: 26 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.