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NCT Number: NCT06980961

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)

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Key information

Conditions

Stasis Dermatitis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 (treatment of varicose veins of the lower limbs) by any of the available techniques

Exclusion criteria

  • 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.

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Treatment and study plan

short-pulse ND: YAG 1064 laser

Procedure

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).

Other names: Arm 1

ultra-short-pulse ND: YAG 1064 laser

Procedure

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).

cold cream

Drug

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

  1. Colorimetry

    Time frame: 6 months

    The skin tone dissimilarity (expressed as ΔE) at treated and adjacent areas measured with digital calorimetry. The ΔE value derives from the differences in the International Commission on Illumination L*a*b* (CIELAB) color space. It is a structured approach to quantifying color differences, with specific intervals indicating varying levels of perceptibility with different intensities of pigmentation:

    • 0 < ∆E < 1 - the difference is unnoticeable
    • 1 < ∆E< 2 - the difference is only noticed by an experienced observer (mild),
    • 2 < ∆E < 3.5 - the difference is also noticed by an inexperienced observer (light),
    • 3.5 < ∆E < 5 - the difference is noticeable (moderate),
    • 5 < ∆E - gives the impression that these are two different colors (intense) In all sessions, patients will be submitted to colorimetric analysis. The ∆E is the skin color difference between the treated and adjacent areas.

Secondary outcomes

  1. Photographic analysis

    Time frame: 6 months

    The co-primary outcome will be the incidence of post-procedure skin hyperpigmentation improvement after six treatment sessions, evaluated through before-and-after photo documentation analysis by three experienced, independent, and blind observers.

    All the evaluators will have access to high-definition before-and-after pictures of the patient's legs that were designated for them. Then, according to their expertise, they will answer the question, "Do you think there's post-treatment improvement in hyperpigmentation in the treated areas of this limb, yes or no?" for the affected limb. The answers chosen by most of the evaluators will be considered for data analysis.

  2. Number of participants with treatment-related adverse events as assessed by clinical evaluation.

    Time frame: 6 months

    Safety analysis will be carried out by clinical evaluation in all pre-scheduled visits. It includes clinical analysis of potential skin alterations such as abnormal redness, swelling, temporary changes in skin pigmentation (hyper- or hypopigmentation), petechia, scarring, or burns. It will be reported as the number of participants with treatment-related adverse events.

Other outcomes

  1. DLQI - quality-of-life

    Time frame: 6 months

    The DLQI will be applied in the baseline and final visits and includes 10 questions:

    • Symptoms: How itchy, sore, painful, or stinging the skin has been.
    • Embarrassment: How embarrassed or self-conscious one has been due to their skin.
    • Daily Activities: How much has the skin condition interfered with shopping, home care, or gardening?
    • Clothing: How much has the skin condition influenced the clothes worn?
    • Social/Leisure: How much has the skin condition affected social or leisure activities?
    • Sport: How much the skin condition has made it difficult to do sports.
    • Work/Study: Whether the skin condition has prevented working or studying, and if not, how much it has been a problem.
    • Personal Relationships: How much the skin condition has created problems with close relationships.
    • Sex: How much the skin condition has caused sexual difficulties.
    • Treatment: How much the treatment for the skin condition has been a problem, considering factors like time or mess.

Study contacts

Contact information is provided by the study sponsor or research team.

Valéria Aguiar, MD

CONTACT

[email protected]

+5511950212099

Sponsors and collaborators

Lead sponsor

Science Valley Research Institute

Other

Registry information

Official study title

Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial

Acronym: SUPERSTAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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