Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser for Soft Tissue Coagulation in Keratosis Pilaris
Johns Hopkins University
25 participants
Oct 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria15
- 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
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Interventions
The investigators will use the LaseMD LEO Laser System (1927-nm Thulium laser) to create controlled, localized microscopic treatment zones (MTZs) of thermal injury to treatment area (unilateral upper arm). The investigators will utilize the random mode using the C1 tip (spot size 200 micrometers), which involves irradiation of the entire upper arm until diffuse erythema and edema appear. Additionally, the investigators may use the C5 tip (350 micrometers spot size) for focused treatment, up to five passes, until coagulation becomes evident. The maximum fluence for all C1 tip is 3-60 J/cm2 and 1-20 J/cm2 for C5 tips. The maximum pulse energy is 20 J with a pulse duration of 20 ms.
Locations(1)
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NCT07078461