An interventional study of short-pulse ND: YAG 1064 laser and ultra-short-pulse ND: YAG 1064 laser in Stasis Dermatitis, sponsored by Science Valley Research Institute. Recruiting at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Science Valley Research Institute · Not applicable, Interventional, and Treatment
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)
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 is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Laser treatment
Procedure: short-pulse ND: YAG 1064 laser
Laser treatment
Procedure: ultra-short-pulse ND: YAG 1064 laser
Control vehicle (cold cream)
Drug: cold cream
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).
Also known as: Arm 1
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).
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.
Colorimetry
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.
Time frame: 6 months
Photographic analysis
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.
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by clinical evaluation.
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.
Time frame: 6 months
DLQI - quality-of-life
The DLQI will be applied in the baseline and final visits and includes 10 questions: 1. Symptoms: How itchy, sore, painful, or stinging the skin has been. 2. Embarrassment: How embarrassed or self-conscious one has been due to their skin. 3. Daily Activities: How much has the skin condition interfered with shopping, home care, or gardening? 4. Clothing: How much has the skin condition influenced the clothes worn? 5. Social/Leisure: How much has the skin condition affected social or leisure activities? 6. Sport: How much the skin condition has made it difficult to do sports. 7. Work/Study: Whether the skin condition has prevented working or studying, and if not, how much it has been a problem. 8. Personal Relationships: How much the skin condition has created problems with close relationships. 9. Sex: How much the skin condition has caused sexual difficulties. 10. Treatment: How much the treatment for the skin condition has been a problem, considering factors like time or mess.
Time frame: 6 months
Plan to share: Yes — Anonymized participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed based on scientific merit. After a proposal is approved, data can be shared through a secure online platform upon signing a data access agreement.
Supporting information: Study protocol, Informed consent form
Time frame: 2 years
Access criteria: Anonymised participant data can be made available upon requests directed to the corresponding author. Proposals will be reviewed on the basis of scientific merit. After approval of a proposal, data can be shared through a secure online platform after signing a data access agreement.
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