Recruiting
Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
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)
ClinicalTrials.gov IDNCT06980961
PhaseNA
Enrollment20
SponsorScience Valley Research Institute
AgeNo minimum reported
SexALL
Conditions studied
Stasis Dermatitis
About this study
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)
Interventions
- Procedure: short-pulse ND: YAG 1064 laser — 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).
- Procedure: ultra-short-pulse ND: YAG 1064 laser — 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).
- Drug: cold cream — 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.
Primary outcomes
- Colorimetry (6 months)
Eligibility information
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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Study locations
- Clinica Ramacciotti, Santo André, São Paulo 09090401 Brazil
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.