Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis (NCT06946550) | Clinical Trial Compass
RecruitingNot Applicable
Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
United States5 participantsStarted 2025-12-09
Plain-language summary
The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults. The study will also investigate the biochemical molecular pathways involved in laser therapy by analyzing hair follicle gene expression before and after laser treatment.
The main questions it aims to answer are:
1. Does a non-ablative laser work to effectively treat scarring alopecia?
2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia?
Participants with scarring alopecia will:
* Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15)
* Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous.
* Fill out questionnaires at each visit
* Keep a diary of any side effects from laser treatments
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia
* Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form
* Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
* Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated throughout the follow-up period.
Exclusion Criteria:
* Subject does not have capacity to consent to the study
* No ethnic or racial group restrictions
* Subject does not have scarring alopecia
* History of intralesional steroid injections to the scalp in the last 12 months
* Pregnant Women
* Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
* Any previous hospitalization or surgical pr…
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.