Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis

• Status: Enrolling by invitation
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Tretinoin

Criteria

Inclusion criteria

Subjects who meet the following inclusion criteria will be included in the study:

• Male or female older than 18 at the screening visit;

• The subject is healthy, as determined by the investigator based on a medical evaluation including medical history;

• The subject has clinical diagnosis of CCCA;

• The subject's CCCA is of grades 2, 3 or 4, as assessed at the time of the screening visit.

• The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule, concomitant therapy and hair processing prohibitions, subject instructions, and biopsy procedures;

• The subject is willing to comply with the month long washout period if deemed necessary;

• The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure Exclusion criteria

Any subject who is meeting one or more of the following exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:

• The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk

• The subject presents with any disease known or described to potentially interfere with a normal wound healing process

• The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period (by self report)

• The subject has a past history of coagulation trouble

• The subject has a past history of abnormal healing (hypertrophic scars/keloids within the past 10 years)

• The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations

• The subject has scars, sunburn, either damaged or broken (cuts or abrasions) skin or other blemishes, or tattoos on the scalp in the treatment area

• The subject is unwilling or unable to refrain from specific types of chemical hair styling and processing, including perms, straighteners, relaxers, dyes, weaves

• The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. lidocaine) or a local antiseptic planned to be used for the laser and/or biopsy procedures

• The subject is in an exclusion period from a previous study or is participating in another clinical trial

• The subject is an adult under guardianship or is hospitalized in a public or private institution, or is deprived of freedom

• The subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function