Status:
COMPLETED
Safety and Efficacy of HST 001 in Male Pattern Hair Loss
Lead Sponsor:
Histogen
Conditions:
Male Pattern Hair Loss
Eligibility:
MALE
25-55 years
Phase:
PHASE1
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 conce...
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 partic...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04435847
Start Date
May 26 2020
End Date
January 20 2021
Last Update
March 19 2021
Active Locations (1)
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1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024