Actively Recruiting

Phase Not Applicable
All Genders
NCT06980961

Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis

Led by Science Valley Research Institute · Updated on 2025-05-20

20

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

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)

CONDITIONS

Official Title

Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Women or men aged 18 to 89 years with stasis dermatitis secondary to venous hypertension
  • Agree to the study terms and sign the informed consent form
  • Available to attend all treatment and follow-up visits
  • Agree to avoid pregnancy during the treatment period
  • Have previously treated primary venous hypertension (such as varicose veins in lower limbs) by any available method
Not Eligible

You will not qualify if you...

  • Men and women with CEAP 2 to 6 and low mobility but no stasis dermatitis
  • Peripheral arterial disease
  • Known allergy to study drugs
  • Other types of dermatitis on lower limbs, such as allergic stasis eczema
  • Comorbidities including diabetes, heart failure, respiratory failure, hypertension, thyroid disorders, pregnancy, breastfeeding, pulmonary hypertension, deep vein thrombosis, family history of DVT, hypercoagulable conditions, asthma, or migraine
  • Anyone who does not agree with the study terms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinica Ramacciotti

Santo André, São Paulo, Brazil, 09090401

Actively Recruiting

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Research Team

V

Valéria Aguiar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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