NCT06980961Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 20 May 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Science Valley Research Institute
- Diseases
- High blood pressure
- NCT number
- NCT06980961
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 20 May 2025 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.
- Anyone who does not agree with any of the search terms.
- \-
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Ramacciotti Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.