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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

  1. Must be 25 to 55 years of age inclusive, at the time of signing the informed consent
  2. Should be in good general health with a healthy scalp with no cutaneous disorder determined by medical history or physical examination
  3. 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
  4. 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
  5. Must be Male.
  6. Willing to have two dot tattoos of the scalp
  7. 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
  8. Willing to comply with scheduled 7 visits in 26 weeks (or screening in + 6 = 7 visits)
  9. Willing to continue normal hair care shampoo throughout the course of the study
  10. Willing to maintain the same hair care routine and forgo the use of new scalp products, throughout the study
  11. Willing to undergo routine venipuncture for safety laboratory testing as well as a blood spot test for Vitamin D level analysis
  12. Capable of giving informed consent
  13. Fluent and literate in English
  14. Able to follow instructions and likely to complete all study visits as assessed by investigator and staff

Exclusion Criteria

  1. History of keloid formation or significant hyperpigmentation
  2. History of other forms of hair loss - Alopecia areata, trichotillomania, scarring alopecia etc.
  3. History of acute or chronic illness that in the opinion of the investigator might confound the results of the study including some drug medications
  4. 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
  5. Routine use of prescription anti inflammatory medications, immunosuppressive drugs, or antihistamine medications
  6. Use of topical drugs or other cosmetics on the scalp
  7. Use of over the counter (OTC) or prescriptive topical hair treatments, including hair transplantation during the last 6 months
  8. Currently using a hair system or wig
  9. History of hair transplants or scalp reduction surgery
  10. History of allergy or intolerance to lidocaine and/or epinephrine
  11. Use of hair dye within 3 days of the treatments, otherwise, willing to maintain the same hair color for the study duration
  12. Current enrollment in an investigational drug or device study
  13. Has tattoos or scars in scalp that would interfere with visual assessment
  14. Is an employee of the investigator's site, and employee or representative of Histogen, investor, or a relative with one of the above
  15. 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
  16. Known allergy to rice
  17. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: HST 001
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
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
26 Weeks
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
26 Weeks
Serum collection for Anti-Drug Antibodies
Time Frame: 26 Weeks
Serum collection for testing for Anti-Drug Antibodies
26 Weeks
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).
18 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
18 Weeks
Absolute change from baseline total TAHC in the vertex and right temporal areas.
Time Frame: 26 Weeks
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).
26 Weeks
Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.
Time Frame: 26 Weeks
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.
26 Weeks
Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.
Time Frame: 26 Weeks
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.
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
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.
26 Weeks
Participant global assessment of hair growth.
Time Frame: 26 Weeks
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.
26 Weeks
Evaluating investigator global assessment of hair growth.
Time Frame: 26 Weeks
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.
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Histogen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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