Safety and Efficacy of HST 001 in Male Pattern Hair Loss

NCT04435847 | Completed Phase 1 FDA Drug

• 1 other identifier: HST 001-AES-003-HG
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Male Pattern Hair Loss

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  26 Weeks

• Adverse Events

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

  26 Weeks

• Serum collection for Anti-Drug Antibodies

  Serum collection for testing for Anti-Drug Antibodies

  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).

  18 Weeks

Secondary Outcomes (7)

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

  18 Weeks

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

  26 Weeks

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

  26 Weeks

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

  26 Weeks

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

  26 Weeks

Study Arms (2)

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.

Biological: HST 001

Placebo - Phosphate Buffered Saline

PLACEBO COMPARATOR

Phosphate Buffered Saline

Other: Phosphate Buffered Saline

Interventions

HST 001 BIOLOGICAL

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).

HST 001

Phosphate Buffered Saline OTHER

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).

Placebo - Phosphate Buffered Saline

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Histogen: lead

Study Sites (1)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 17, 2020
• Study Start: May 26, 2020
• Primary Completion: November 11, 2020
• Study Completion: January 20, 2021
• Last Updated: March 19, 2021

Record last verified: 2020-08

Locations

US (1)