Using lasers to treat skin lesions from stasis dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

   \-

Where it's running

• Clinica Ramacciotti
  Santo André, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Valéria Aguiar, MD
• Email: val.aguiarvasc@gmail.com
• Phone: +5511950212099

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brazilian Registry of Menopausal Health

  This study tests how health, knowledge, and quality of life during menopause vary by region and socioeconomic factors in people aged 35 to 65 who are in the menopausal transition or postmenopause.

  Recruiting Science Valley Research Institute · São Paulo, São Paulo · NCT07005648

• Absorbable oxandrolone implant to help recovery after ACL reconstruction

  This test will see if a bioabsorbable oxandrolone pellet placed under the skin helps men and women recover muscle mass, strength, and knee function after ACL reconstruction.

  Recruiting at 6 sites Phase 2 Science Valley Research Institute · Fortaleza, Ceará and 5 other locations · NCT06974526

• Comparing Pulsed Electromagnetic Field Therapy and Pneumatic Compression for Preventing Blood Clots in ICU Patients

  This study is testing whether Pulsed Electromagnetic Field Therapy works better than pneumatic compression to prevent blood clots in ICU patients who can't take medication for it.

  Recruiting Phase 4 Science Valley Research Institute · Belo Horizonte, BH · NCT06958588

• Evaluating VTE Prevention with Rivaroxaban and Aspirin After Lower Limb Surgery

  This study is testing if taking a combination of rivaroxaban and aspirin after lower limb surgery can help prevent blood clots better than just taking aspirin alone.

  Recruiting Phase 4 Science Valley Research Institute · Pernambuco, Pernambuco · NCT06873321

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.