Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
NCT03491267 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-07-03
Summary
The investigators have extensive evidence in mouse that wounding leads to the generation of new hair follicles in the skin. This can be an important new therapy for patients with scarring, but especially those with alopecia.
The question is whether gentle wounding in human subjects can cause the generation of a new hair follicle.
The plan is to first carefully map a small area of the scalp without hair follicles. Investigators will then try various modalities of gentle wounding (including fractionated Carbon Dioxide (CO2) laser, mild curetting) of the surface epithelium in the presence and absence of FDA approved topical medications (including retinoids). Investigators will then prospectively monitor the area for hair growth both by noninvasive visual monitoring (including photographs and dermoscopy) and biopsies.
The outcomes of this study hopefully will allow new therapies for especially scarring alopecia conditions where hair follicles are completely lost and there are no current therapies.
Conditions
- Central Centrifugal Cicatricial Alopecia (CCCA)
Interventions
- DRUG
-
Retinoic acid
The study team will treat skin with topical retinoic acid
- DEVICE
-
Laser
The study team treat skin with a surface laser.
- DRUG
-
Sham treatment
No drug will be given
- DEVICE
-
Sham treatment
No laser treatment will be given
Sponsors & Collaborators
-
National Institute Of Arthritis & Musculoskeletal & Skin Diseases
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Luis Garza, MD/PhD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-01
- Primary Completion
- 2024-11-01
- Completion
- 2024-11-01
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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