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

Recruiting now · Not applicable

Conditions studied: Stasis Dermatitis

In brief

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)

Key facts

Study ID

NCT06980961

Run by

Science Valley Research Institute

People needed

20

Starts

2025-05-20

Expected to finish

2026-12-01

Last updated by the study team

2025-05-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Clinica Ramacciotti — Santo André, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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