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

NCT06980961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-20

No results posted yet for this study

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)

Conditions

  • Stasis Dermatitis

Interventions

PROCEDURE

short-pulse ND: YAG 1064 laser

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).

PROCEDURE

ultra-short-pulse ND: YAG 1064 laser

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).

DRUG

cold cream

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.

Sponsors & Collaborators

  • Science Valley Research Institute

    lead OTHER

Principal Investigators

  • Eduardo Ramacciotti, MD, Ph.D, livre docente · Science Valley Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2026-10-01
Completion
2026-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06980961 on ClinicalTrials.gov