Recruiting

Thulium Laser

Sponsor:

Johns Hopkins University

Code:

NCT07078461

Conditions

Keratosis Pilaris (KP)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

1927-nm Thulium Laser therapy

Study Details

Brief 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.

Conditions

Keratosis Pilaris (KP)

Study ID

NCT07078461

Start date

Oct 23, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

1927-nm Thulium Laser therapy

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.

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 and Locations

Central contacts

Youkyung S Roh, MD

410-502-7546yroh2@jhmi.edu

Ruizhi Wang

410-502-7546rwang@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Ruizhi Wang

410-502-7546rwang@jhmi.edu

Principal Investigator:

Sarah Hsu, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • keratosis pilaris
  • thulium
  • laser

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-26.