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

Launched by SCIENCE VALLEY RESEARCH INSTITUTE · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of two types of lasers, called ND YAG 1064 short and ultra-short pulses, to treat a skin condition known as stasis dermatitis. This condition often occurs when blood flow in the veins is poor, leading to dark patches on the skin. The trial aims to see how effective these lasers are in helping patients with these skin changes related to venous hypertension, which is a condition caused by problems with blood flow in the legs.

To participate in this study, candidates must be adults aged 18 to 89 who have been diagnosed with stasis dermatitis due to venous hypertension and have already received treatment for their vein issues. Participants will need to be available for treatments and follow-up appointments, and they must agree to avoid pregnancy during the study. However, people with certain medical conditions, allergies, or other types of dermatitis will not be eligible. If chosen for the trial, participants can expect to receive laser treatments and regular check-ins with the study team to monitor their progress.

Gender

ALL

Eligibility criteria

• 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.
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