RECRUITING

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

Conditions

Keratosis Pilaris (KP)keratosis pilaris thulium laser

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating the Safety and Efficacy of the 1927-nm Thulium Laser for Soft Tissue Coagulation in Keratosis Pilaris

Quick Facts

Study Start:2025-08

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07078461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Youkyung S Roh, MD

CONTACT

410-502-7546

yroh2@jhmi.edu

Ruizhi Wang

CONTACT

410-502-7546

rwang@jhmi.edu

Principal Investigator

Sarah Hsu, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Myriam Gonzalez, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Sarah Hsu, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
Myriam Gonzalez, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-08

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

keratosis pilaris
thulium
laser

Additional Relevant MeSH Terms

Keratosis Pilaris (KP)