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

Science Valley Research Institute

Status: Enrolling

Conditions: Stasis Dermatitis

Treatments: Drug: cold cream; Procedure: short-pulse ND: YAG 1064 laser; Procedure: ultra-short-pulse ND: YAG 1064 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT06980961

SUPERSTAR trial

Details and patient eligibility

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)

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups, including a placebo group

Arm 1: ND YAG laser: 1064 nm short pulse (nanoseconds) - Omer Smart

Experimental group

Description:

Laser treatment

Treatment:

Procedure: short-pulse ND: YAG 1064 laser

Arm 2: ND YAG laser: 1064 nm ultra- short pulse (picoseconds) - omer Premium

Experimental group

Description:

Laser treatment

Treatment:

Procedure: ultra-short-pulse ND: YAG 1064 laser

Arm 3

Placebo Comparator group

Description:

Control vehicle (cold cream)

Treatment:

Drug: cold cream