Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris

Conditions

• Keratosis Pilaris (KP)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• 1927-nm Thulium Laser therapy — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 23, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1927-nm Thulium Laser therapy (right arm)
  Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the right arm.
• Active Comparator: 1927-nm Thulium Laser therapy (left arm)
  Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the left arm.

Primary Outcome Measure

Disease Severity as assessed by the Investigator's Global Assessment (IGA) [ Time Frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months ]

Central Contacts

• Youkyung S Roh, MD
  410-502-7546
  [email protected]
• Ruizhi Wang
  410-502-7546
  [email protected]

Locations (1)

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