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Safety and Efficacy of HST 001 in Male Pattern Hair Loss

Primary Purpose

Male Pattern Hair Loss

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HST 001

Phosphate Buffered Saline

About this trial

This is an interventional treatment trial for Male Pattern Hair Loss

Eligibility Criteria

25 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

California Dermatology & Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HST 001

Placebo - Phosphate Buffered Saline

Arm Description

Phosphate Buffered Saline

Outcomes

Primary Outcome Measures

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.

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.

Adverse Events

Safety and tolerability of HST 001 by comparing adverse events to baseline

Serum collection for Anti-Drug Antibodies

Serum collection for testing for Anti-Drug Antibodies

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).

Secondary Outcome Measures

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).

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).

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04435847

First Posted

May 26, 2020

Last Updated

March 17, 2021

Sponsor

Histogen

1. Study Identification

Unique Protocol Identification Number

NCT04435847

Brief Title

Safety and Efficacy of HST 001 in Male Pattern Hair Loss

Official Title

Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With Male Pattern Hair Loss

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

May 26, 2020 (Actual)

Primary Completion Date

November 11, 2020 (Actual)

Study Completion Date

January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Histogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Male Pattern Hair Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HST 001

Arm Type

Experimental

Arm Description

Arm Title

Placebo - Phosphate Buffered Saline

Arm Type

Placebo Comparator

Arm Description

Phosphate Buffered Saline

Intervention Type

Biological

Intervention Name(s)

HST 001

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Phosphate Buffered Saline

Intervention Description

Primary Outcome Measure Information:

Title

Participant assessment of procedural pain.

Description

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.

Time Frame

26 Weeks

Title

Participant assessment of pain or other treatment site responses.

Description

Time Frame

26 Weeks

Title

Adverse Events

Description

Safety and tolerability of HST 001 by comparing adverse events to baseline

Time Frame

26 Weeks

Title

Serum collection for Anti-Drug Antibodies

Description

Serum collection for testing for Anti-Drug Antibodies

Time Frame

26 Weeks

Title

Absolute change from baseline total hairs in the target area (TAHC) of the vertex.

Description

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).

Time Frame

18 Weeks

Secondary Outcome Measure Information:

Title

Absolute change from baseline total TAHC of the right temporal region.

Description

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).

Time Frame

18 Weeks

Title

Absolute change from baseline total TAHC in the vertex and right temporal areas.

Description

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).

Time Frame

26 Weeks

Title

Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.

Description

Time Frame

26 Weeks

Title

Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.

Description

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.

Time Frame

26 Weeks

Title

Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.

Description

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.

Time Frame

26 Weeks

Title

Participant global assessment of hair growth.

Description

Time Frame

26 Weeks

Title

Evaluating investigator global assessment of hair growth.

Description

Time Frame

26 Weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

California Dermatology & Clinical Research Institute

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

12. IPD Sharing Statement

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Safety and Efficacy of HST 001 in Male Pattern Hair Loss

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