Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis

Официальное название

Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial

Обзор

This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis)

Подробное описание

Background: Stasis dermatitis with hyperpigmented skin lesions is a serious health problem for patients with chronic venous hypertension. Although no randomized studies have evaluated lasers for this treatment, lasers can be an attractive option.

Methods: This prospective, randomized, 3-arm, open-label, vehicle-controlled study will enroll patients scheduled to undergo treatment for stasis dermatitis with hyperpigmented skin lesions. Patients will be allocated to either Nd: YAG 1064 nm short pulse laser-nanoseconds (group 1), or Nd: YAG 1064 nm ultra-short-pulse laser-picoseconds (group 2), or cold cream vehicle control (group 3). All treatments are scheduled for 6 visits with pre-defined dates, with a final follow-up visit at intervals of 28 to 35 days. Primary outcomes include colorimetry analysis, secondary outcomes pre- and post-photographic analysis, and DLQI quality-of-life assessment.

Conclusions: The results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.

Вмешательства

• Процедура short-pulse ND: YAG 1064 laser
  Nd: YAG 1064 nm short pulse laser (5 nanoseconds), 4 mm spot size, from 100 to 1000 mJ total energy, treatment scheduled for six visits with pre-defined dates, with intervals of 28 to 35 days. The device will be Omer Smart, a Q-Switch Laser produced by Medical San (Lajeado, RS, Brazil).
• Процедура ultra-short-pulse ND: YAG 1064 laser
  Nd: YAG1064 nm ultra-short pulse laser (400 picoseconds), 2 to 10 mm spot size, from 100 to 1000 mJ total energy, treatment scheduled for 6 visits with pre-defined dates, with intervals of 28 to 35 days. The device will be Omer Premium, a picolaser produced by Medical San (Lajeado, RS, Brazil).
• Препарат cold cream
  The control vehicle is a cold cream, supplied by HERVA'S manipulation pharmacy. The composition of cold cream will be beeswax, acetyl palmitate, BHA, cetearyl alcohol, propylparaben, and water. This topical agent will be applied to patients daily throughout the treatment period. It is scheduled for six visits with pre-defined dates, with intervals of 28 to 35 days.

Первичные конечные точки

• Colorimetry [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Photographic analysis [Срок оценки: 6 months]
• Number of participants with treatment-related adverse events as assessed by clinical evaluation. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
• Agreement with the terms of the survey and signing of the informed consent form
• Availability to make the necessary appointments for treatment and follow-up
• Provide consent to avoid pregnancy during treatment
• Have primary venous hypertension already treated (treatment of varicose veins of the lower limbs) by any of the available techniques

Критерии исключения

• Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
• Peripheral arterial disease.
• History of known allergy to the drugs used in this study
• Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.
• Presence of comorbidities (such as diabetes mellitus, heart failure, respiratory failure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history of DVT, known hypercoagulable states or thrombophilia, asthma, and migraine.
• Anyone who does not agree with any of the search terms.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Clinica Ramacciotti — Santo André

Публикации

• Vyas J, Johns JR, Ali FM, Ingram JR, Salek S, Finlay AY. A Systematic Review of 207 Studies Describing Validation Aspects of the Dermatology Life Quality Index. Acta Derm Venereol. 2024 Nov 7;104:adv41120. doi: 10.2340/actadv.v104.41120. PMID 39508500
• Liu C, Huang HY, Chang YY, Sun CK, Chia SH, Liao YH. Optical Effects of Focused Fractional Nanosecond 1064-nm Nd:YAG Laser: Techniques of Application on Human Skin. Lasers Surg Med. 2024 Aug;56(6):557-563. doi: 10.1002/lsm.23812. Epub 2024 Jun 18. PMID 38890780
• Ma S, Zhu H, Chen J, Chen F, Wu Y, He S, Li Y, Gong Y, Zhu H. Analysis of efficacy of picosecond laser treatment for nevus of Ota. Lasers Med Sci. 2025 Feb 6;40(1):72. doi: 10.1007/s10103-025-04322-0. PMID 39913065
• Silverberg JI, Kirsner RS, Margolis DJ, Tharp M, Myers DE, Annis K, Graham D, Zang C, Vlahos BL, Sanders P. Efficacy and safety of crisaborole ointment, 2%, in participants aged >/=45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study. J Am Acad Dermatol. 2024 May;90(5):945-952. doi: 10.1016/j.jaad.2023.12.048. Epub 2024 Feb 8. PMID 38340127
• Shriver MD, Parra EJ. Comparison of narrow-band reflectance spectroscopy and tristimulus colorimetry for measurements of skin and hair color in persons of different biological ancestry. Am J Phys Anthropol. 2000 May;112(1):17-27. doi: 10.1002/(SICI)1096-8644(200005)112:13.0.CO;2-D. PMID 10766940
• Basra MK, Chowdhury MM, Smith EV, Freemantle N, Piguet V. A review of the use of the dermatology life quality index as a criterion in clinical guidelines and health technology assessments in psoriasis and chronic hand eczema. Dermatol Clin. 2012 Apr;30(2):237-44, viii. doi: 10.1016/j.det.2011.11.002. Epub 2011 Dec 21. PMID 22284138
• Weatherall IL, Coombs BD. Skin color measurements in terms of CIELAB color space values. J Invest Dermatol. 1992 Oct;99(4):468-73. doi: 10.1111/1523-1747.ep12616156. PMID 1402005
• Ly BCK, Dyer EB, Feig JL, Chien AL, Del Bino S. Research Techniques Made Simple: Cutaneous Colorimetry: A Reliable Technique for Objective Skin Color Measurement. J Invest Dermatol. 2020 Jan;140(1):3-12.e1. doi: 10.1016/j.jid.2019.11.003. PMID 31864431

Идентификаторы

NCT: NCT06980961 · SUPERSTAR trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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