Using lasers to treat skin lesions from stasis dermatitis

Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial

This study is testing whether two different types of lasers can effectively treat dark skin spots caused by stasis dermatitis in people with poor blood flow.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sex: All
• Sponsor: Science Valley Research Institute (Academic / other)
• Locations: 1 site (Santo André, São Paulo)
• Trial ID: NCT06980961 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of two types of lasers, short-pulse and ultra-short-pulse Nd:YAG 1064 nm, in treating hyperchromic skin lesions caused by stasis dermatitis due to venous hypertension. It is a prospective, randomized, 3-arm, open-label, vehicle-controlled trial that will enroll patients scheduled for treatment. Participants will be assigned to one of three groups: one receiving the short-pulse laser, another receiving the ultra-short-pulse laser, and a control group receiving a cold cream. The study aims to assess outcomes through colorimetry analysis and quality-of-life assessments over a series of treatment visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 89 with stasis dermatitis secondary to venous hypertension who have previously undergone treatment for varicose veins.

Not a fit: Patients with other types of dermatitis, significant comorbidities, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of skin lesions and quality of life for patients suffering from stasis dermatitis.

How similar studies have performed: While there have been no randomized studies specifically evaluating lasers for this condition, lasers have shown promise in treating similar dermatological issues.

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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Where this trial is running

Santo André, São Paulo

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

Study contacts

• Study coordinator: Valéria Aguiar, MD

Conditions Stasis Dermatitis; laser; stasis dermatitis; hyperchromic skin lesions