Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis (NCT03491267) | Clinical Trial Compass
CompletedEarly Phase 1
Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
United States24 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Number of New Hairs
Timeframe: baseline and 9 weeks post treatment (up to 6 months of treatment)