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

Not Applicable

Recruiting

• Conditions: Stasis Dermatitis
• Interventions: Drug: cold cream

• Registration Number: NCT06980961
• Lead Sponsor: Science Valley Research Institute

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)

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study Start: 2025-05-20
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.

2. Peripheral arterial disease.

3. History of known allergy to the drugs used in this study

4. Presence of other types of dermatitis in the lower extremities, such as allergic stasis eczema.

5. 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.

6. Anyone who does not agree with any of the search terms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	cold cream	Control vehicle (cold cream)

Primary Outcome Measures

Name	Time	Method
Colorimetry	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Photographic analysis	6 months	The co-primary outcome will be the incidence of post-procedure skin hyperpigmentation improvement after six treatment sessions, evaluated through before-and-after photo documentation analysis by three experienced, independent, and blind observers.; All the evaluators will have access to high-definition before-and-after pictures of the patient's legs that were designated for them. Then, according to their expertise, they will answer the question, "Do you think there's post-treatment improvement in hyperpigmentation in the treated areas of this limb, yes or no?" for the affected limb. The answers chosen by most of the evaluators will be considered for data analysis.
Number of participants with treatment-related adverse events as assessed by clinical evaluation.	6 months	Safety analysis will be carried out by clinical evaluation in all pre-scheduled visits. It includes clinical analysis of potential skin alterations such as abnormal redness, swelling, temporary changes in skin pigmentation (hyper- or hypopigmentation), petechia, scarring, or burns. It will be reported as the number of participants with treatment-related adverse events.

Trial Locations

Locations (1)

Clinica Ramacciotti; 🇧🇷 Santo Andre, SP, Brazil