Last updated 42 days ago

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

20 patients around the world
Available in Brazil
Background: Stasis dermatitis with hyperpigmented skin lesions is a serious health problem for patients with chronic venous hypertension. Although no randomized studies have evaluated lasers for this treatment, lasers can be an attractive option. Methods: This prospective, randomized, 3-arm, open-label, vehicle-controlled study will enroll patients scheduled to undergo treatment for stasis dermatitis with hyperpigmented skin lesions. Patients will be allocated to either Nd: YAG 1064 nm short pulse laser-nanoseconds (group 1), or Nd: YAG 1064 nm ultra-short-pulse laser-picoseconds (group 2), or cold cream vehicle control (group 3). All treatments are scheduled for 6 visits with pre-defined dates, with a final follow-up visit at intervals of 28 to 35 days. Primary outcomes include colorimetry analysis, secondary outcomes pre- and post-photographic analysis, and DLQI quality-of-life assessment. Conclusions: The results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.
Science Valley Research Institute
1Research sites
20Patients around the world

This study is for people with

Dermatitis
Stasis Dermatitis

Requirements for the patient

All Gender

Medical requirements

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 by any of the available techniques.
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.

Sites

Clínica Ramacciotti
Recruiting
R. Catequese, 725 - Vila Guiomar, Santo André - SP, 09090-401, Brazil
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