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

NCT ID: NCT07078461

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-23
• Study Completion Date: 2026-12-31

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.

Detailed Description

The non-ablative fractional 1927nm Thulium laser (LaseMD ULTRA) is approved by the Food and Drug Administration (FDA) for use in dermatological procedures requiring soft-tissue coagulation, such as treatment of actinic keratosis (pre-cancerous spots), and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles). It is not approved for use for soft-tissue coagulation in keratosis pilaris.

It has been used in previous studies to treat conditions including acne scarring, skin rejuvenation, enlarged sebaceous glands, dyschromia, rosacea, and actinic keratoses. Its role as a potential treatment option for KP, remains unexplored.

Conditions

Keratosis Pilaris (KP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1927-nm Thulium Laser therapy (right arm)

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

Group Type: ACTIVE_COMPARATOR

1927-nm Thulium Laser therapy

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

1927-nm Thulium Laser therapy

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Myriam Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Youkyung S Roh, MD

Role: CONTACT

yroh2@jhmi.edu

410-502-7546

Ruizhi Wang

Role: CONTACT

rwang@jhmi.edu

410-502-7546

Facility Contacts

Ruizhi Wang

Role: primary

rwang@jhmi.edu

410-502-7546

References

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.

Reference Type: BACKGROUND

PMID: 23041112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35917264 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38447098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37564689 (View on PubMed)

Other Identifiers

IRB00461291

Identifier Type: -

Identifier Source: org_study_id