Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris (NCT07078461) | Clinical Trial Compass
RecruitingNot Applicable
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
United States25 participantsStarted 2025-10-23
Plain-language summary
Keratosis pilaris (KP) is a very common skin condition that affects up to 80% of adolescents and 40% of adults. Clinically, KP causes rough dry patches and tiny spiny bumps around the hair follicles, as well as redness and pigmentation changes, most often on the upper arms, thighs, cheeks, or buttocks. While KP is benign, it can be cosmetically very bothersome. Currently, treatment options for KP are limited, and consist of topical moisturizers and keratolytic agents, but often leads to suboptimal improvements. In literature, many laser treatment modalities for KP have been studied, with varying results. The primary aim of this pilot study is to investigate how KP, a predominantly follicular disorder, responds to treatment with the 1927-nm Thulium laser.
Who can participate
Age range
18 Years – 65 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:
* Female or male, in good health, ages 18-65
* Voluntarily signed informed consent form
* Any Fitzpatrick skin type (I-VI)
* Clinically diagnosed keratosis pilaris of bilateral upper arms
* Willing to have photographs taken and agree to the use of photographs for regulatory, presentation, or marketing purposes
* Willing and able to follow protocol procedures and requirements
Exclusion Criteria:
* History of receiving any laser therapy to the bilateral arms in the 12 months before recruitment
* History of or concurrent use of radiation to the bilateral arms in the 12 months before recruitment
* Participation of other device or drug clinical trials within 1 month before recruitment
* Concurrent diagnosis of active skin condition in the arms
* Presence of an active systemic or local skin disease that may affect wound healing
* History of forming keloids, collagen vascular disease, chronic drug or alcohol use
* History of malignant tumors in the upper arms
* Presence of open ulcers or infections any skin site
* Presence of a tan or sunburn over the upper arms in the month before recruitment
* Use of topical or oral photosensitizing medications
* Excessive body hair or tattoo in target area
* Pregnant and/or breastfeeding
* Presence of any medical conditions that interfere with subject's participation
* History of diagnosed pigmentary disorders in the target area
* Current smoker or history of smoking within 5 years
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
Disease Severity as assessed by the Investigator's Global Assessment (IGA)
Timeframe: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months