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

NCT06980961 | Recruiting

• 1 other identifier: SUPERSTAR trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Stasis Dermatitis

Keywords

laser; stasis dermatitis; hyperchromic skin lesions

Outcome Measures

Primary Outcomes (1)

• Colorimetry

  The skin tone dissimilarity (expressed as ΔE) at treated and adjacent areas measured with digital calorimetry. The ΔE value derives from the differences in the International Commission on Illumination L\*a\*b\* (CIELAB) color space. It is a structured approach to quantifying color differences, with specific intervals indicating varying levels of perceptibility with different intensities of pigmentation: * 0 \< ∆E \< 1 - the difference is unnoticeable * 1 \< ∆E\< 2 - the difference is only noticed by an experienced observer (mild), * 2 \< ∆E \< 3.5 - the difference is also noticed by an inexperienced observer (light), * 3.5 \< ∆E \< 5 - the difference is noticeable (moderate), * 5 \< ∆E - gives the impression that these are two different colors (intense) In all sessions, patients will be submitted to colorimetric analysis. The ∆E is the skin color difference between the treated and adjacent areas.

  6 months

Secondary Outcomes (2)

• Photographic analysis

  6 months

• Number of participants with treatment-related adverse events as assessed by clinical evaluation.

  6 months

Other Outcomes (1)

• DLQI - quality-of-life

  6 months

Study Arms (3)

Arm 1: ND YAG laser: 1064 nm short pulse (nanoseconds) - Omer Smart

EXPERIMENTAL

Laser treatment

Procedure: short-pulse ND: YAG 1064 laser

Arm 2: ND YAG laser: 1064 nm ultra- short pulse (picoseconds) - omer Premium

EXPERIMENTAL

Laser treatment

Procedure: ultra-short-pulse ND: YAG 1064 laser

Arm 3

PLACEBO COMPARATOR

Control vehicle (cold cream)

Drug: cold cream

Interventions

short-pulse ND: YAG 1064 laser PROCEDURE

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).

Also known as: Arm 1

Arm 1: ND YAG laser: 1064 nm short pulse (nanoseconds) - Omer Smart

ultra-short-pulse ND: YAG 1064 laser PROCEDURE

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).

Arm 2: ND YAG laser: 1064 nm ultra- short pulse (picoseconds) - omer Premium

cold cream DRUG

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.

Arm 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Science Valley Research Institute: lead

Study Sites (1)

Clinica Ramacciotti

Santo André, São Paulo, 09090401, Brazil

RECRUITING

Related Publications (16)

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  PMID: 39508500 BACKGROUND

• 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.

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• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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  PMID: 1402005 BACKGROUND

• 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 BACKGROUND

• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

  PMID: 8033378 BACKGROUND

• Liu J, Han C, Feng X, Liang J, Qu Y. Effective Picosecond Nd:YAG laser on seborrheic dermatitis and its mechanism. J Cosmet Dermatol. 2022 Jun;21(6):2449-2457. doi: 10.1111/jocd.14414. Epub 2021 Sep 8.

  PMID: 34496116 BACKGROUND

• Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.

  PMID: 24813302 BACKGROUND

• Dissemond J, Knab J, Lehnen M, Franckson T, Goos M. Successful treatment of stasis dermatitis with topical tacrolimus. Vasa. 2004 Nov;33(4):260-2. doi: 10.1024/0301-1526.33.4.260.

  PMID: 15623206 BACKGROUND

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  PMID: 34748058 BACKGROUND

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  PMID: 28063094 BACKGROUND

• Abbade LP, Lastoria S, Rollo Hde A. Venous ulcer: clinical characteristics and risk factors. Int J Dermatol. 2011 Apr;50(4):405-11. doi: 10.1111/j.1365-4632.2010.04654.x.

  PMID: 21413949 BACKGROUND

• Bergan JJ, Schmid-Schonbein GW, Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. N Engl J Med. 2006 Aug 3;355(5):488-98. doi: 10.1056/NEJMra055289. No abstract available.

  PMID: 16885552 BACKGROUND

Study Officials

• Eduardo Ramacciotti, MD, Ph.D, livre docente

  Science Valley Research Institute

  STUDY CHAIR

Central Study Contacts

Valéria Aguiar, MD

CONTACT

+5511950212099; val.aguiarvasc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior investigator

Model Details: 3 arms parallel study

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 20, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2 years
• Access Criteria: Anonymised participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement.

Locations

BR (1)