1927-nm Thulium laser for keratosis pilaris on the upper arms
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser for Soft Tissue Coagulation in Keratosis Pilaris
We will test if the 1927-nm Thulium laser can reduce bumps, roughness, redness, and pigment from keratosis pilaris on the upper arms in adults aged 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07078461 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study will deliver non-ablative fractional 1927-nm Thulium laser (LaseMD ULTRA) treatments to the bilateral upper arms of adults with clinically diagnosed keratosis pilaris. Participants will be photographed and followed for safety and skin response after treatment, with protocol-defined visits and documentation. The device is FDA‑cleared for other dermatologic uses but is not approved specifically for keratosis pilaris, and prior laser exposure to the arms or active arm skin disease are exclusion criteria. The trial is single‑site at Johns Hopkins and is designed to generate initial safety and efficacy signals for this indication.
Who should consider this trial
Good fit: Adults aged 18–65 in good general health with clinically diagnosed keratosis pilaris on both upper arms, willing to attend in‑person visits and have photos taken, are ideal candidates.
Not a fit: People with active skin disease on the arms, a history of keloids or poor wound healing, recent arm laser or radiation treatment, or recent participation in other device/drug trials may be excluded or unlikely to benefit.
Why it matters
Potential benefit: If successful, the treatment could offer a new option to improve the cosmetic appearance and texture of keratosis pilaris on the upper arms beyond current topical therapies.
How similar studies have performed: Other laser approaches for keratosis pilaris have shown mixed results, and while the 1927-nm Thulium laser has been used successfully for other skin conditions, its effect on KP remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Hsu, MD — Johns Hopkins University
- Study coordinator: Youkyung S Roh, MD
- Email: yroh2@jhmi.edu
- Phone: 410-502-7546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.