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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 f

Первичные конечные точки

• Disease Severity as assessed by the Investigator's Global Assessment (IGA) [Срок оценки: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months]

Вторичные конечные точки (2)

• Global Improvement Scale (GIS) [Срок оценки: 24 weeks, 2 follow up visits up to 3 months]
• Participant Satisfaction [Срок оценки: 24 weeks, 2 follow up visits up to 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins University — Baltimore

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07078461 · IRB00461291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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