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

Johns Hopkins University25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Keratosis Pilaris (KP)

Interventions

1927-nm Thulium Laser therapyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Global Improvement Scale (GIS)

Global Improvement Scale (GIS) as rated by patients at last study visit and at follow-up visit(s). Scale range 0 (no improvement) - 4 (excellent improvement). Higher score better.

Time frame: 24 weeks, 2 follow up visits up to 3 months

Participant Satisfaction

Participant satisfaction rated from 0 (unsatisfied) - 3 (satisfied). Higher score more satisfaction.