Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial
Science Valley Research Institute
20 participants
May 20, 2025
INTERVENTIONAL
Conditions
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)
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria7
- 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.
- \-
Interventions
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).
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).
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06980961