Clinical trial NCT06980961: Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
Official title: Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stasis Dermatitis
Keywords: laser
stasis dermatitis
hyperchromic skin lesions
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arms parallel study
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: Colorimetry
timeFrame: 6 months
Secondary outcomes:
measure: Photographic analysis
timeFrame: 6 months
measure: Number of participants with treatment-related adverse events as assessed by clinical evaluation.
timeFrame: 6 months
Other outcomes:
measure: DLQI - quality-of-life
timeFrame: 6 months
Locations:
city: Santo Andre
country: Brazil
facility: Clinica Ramacciotti
state: SP
Study officials:
affiliation: Science Valley Research Institute
name: Eduardo Ramacciotti, MD, Ph.D, livre docente
role: STUDY_CHAIR
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