1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia (NCT05460611) | Clinical Trial Compass
RecruitingNot Applicable
1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
United States10 participantsStarted 2023-12-07
Plain-language summary
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.
Who can participate
Age range
18 Years – 99 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:
* Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss
* Subject must voluntarily sign and date an IRB approved informed consent form
* Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
* Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months
* Able to read, understand and voluntarily provide written informed consent
* Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regimen 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 through the follow-up period
Exclusion Criteria:
* Subject does not have the capacity to consent to the study
* Subject has other types of alopecia of the scalp like alopecia areata
* 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 surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months
* Allergy or history of prior reaction to lidocaine
* History of immunosuppress…
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.
Timeframe: Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)
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Hair Counts
Timeframe: Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)