Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
Recruiting · NCT06980961 · Interventional (participants receive a specific treatment) · Lead sponsor: Science Valley Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
cold creamshort-pulse ND: YAG 1064 laserultra-short-pulse ND: YAG 1064 laser
What this trial is about
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)
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Clinica Ramacciotti - Santo André, São Paulo, Brazil