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

NCT07078461 | Recruiting DMC FDA Device

• 1 other identifier: IRB00461291
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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)

Keywords

keratosis pilaris; thulium; laser

Outcome Measures

Primary Outcomes (1)

• Disease Severity as assessed by the Investigator's Global Assessment (IGA)

  IGA score will be assessed by two blinded dermatologists for each arm based for two categories (erythema and texture/skin roughness) from standardized digital photographs. Scale ranges from 0 (clear) - 3 (severe). Lower score better.

  6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months

Secondary Outcomes (2)

• Global Improvement Scale (GIS)

  24 weeks, 2 follow up visits up to 3 months

• Participant Satisfaction

  24 weeks, 2 follow up visits up to 3 months

Study Arms (2)

1927-nm Thulium Laser therapy (right arm)

ACTIVE COMPARATOR

Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the right arm.

Device: 1927-nm Thulium Laser therapy

1927-nm Thulium Laser therapy (left arm)

ACTIVE COMPARATOR

Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the left arm.

Device: 1927-nm Thulium Laser therapy

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.

1927-nm Thulium Laser therapy (left arm); 1927-nm Thulium Laser therapy (right arm)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (4)

• Weiss ET, Brauer JA, Anolik R, Reddy KK, Karen JK, Hale EK, Brightman LA, Bernstein L, Geronemus RG. 1927-nm fractional resurfacing of facial actinic keratoses: a promising new therapeutic option. J Am Acad Dermatol. 2013 Jan;68(1):98-102. doi: 10.1016/j.jaad.2012.05.033. Epub 2012 Oct 2.

  PMID: 23041112 BACKGROUND

• Hassan AS, Abdel Aziz M, Saadi DG. Clinical and Dermoscopic Evaluation of Trichloroacetic Acid 20% Versus Long-Pulsed 1064-nm Nd-YAG Laser in the Treatment of Keratosis Pilaris. Dermatol Surg. 2022 Aug 1;48(8):838-842. doi: 10.1097/DSS.0000000000003488. Epub 2022 Jun 15.

  PMID: 35917264 BACKGROUND

• Wong PC, Wang MA, Ng TJ, Akbarialiabad H, Murrell DF. Keratosis pilaris treatment paradigms: assessing effectiveness across modalities. Clin Exp Dermatol. 2024 Sep 18;49(10):1105-1117. doi: 10.1093/ced/llae066.

  PMID: 38447098 BACKGROUND

• Wang MA, Wilson A, Murrell DF. A Review of the Scoring and Assessment of Keratosis Pilaris. Skin Appendage Disord. 2023 Aug;9(4):241-251. doi: 10.1159/000529487. Epub 2023 Apr 20.

  PMID: 37564689 BACKGROUND

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Study Officials

• Sarah Hsu, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Myriam Gonzalez, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youkyung S Roh, MD

CONTACT

410-502-7546; yroh2@jhmi.edu

Ruizhi Wang

CONTACT

410-502-7546; rwang@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort, open-label, split-body, randomized, single-blinded study

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 22, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)