Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-02-03 @ 1:34 AM
Study NCT ID:
NCT06980961
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
Sponsor:
Science Valley Research Institute
Organization:
Study Overview
Official Title:
Short-pulse and Ultra-Short Pulse ND: YAG 1064 Lasers for Stasis Dermatitis Secondary to Chronic Venous Hypertension Treatment: the SUPERSTAR Trial
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPERSTAR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: