Q-switched and ultra-short-pulse Nd:YAG 1064 nm laser treatment for stasis dermatitis secondary to chronic venous hypertension: Rationale and design of the SUPERSTAR trial

BackgroundStasis dermatitis with hyperpigmented skin lesions is a distressing condition for patients with chronic venous hypertension. There are no randomized studies evaluating lasers for the treatment of these patients. Lasers can be an attractive option for treating hyperpigmentation associated with stasis dermatitis.MethodsThis 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 Q-switched Nd: YAG 1064 nm short-pulse nanoseconds, Nd: YAG 1064 nm ultra-short-pulse picoseconds, or cold cream vehicle control. All treatments are scheduled for six visits with pre-defined dates, with a final follow-up visit at 28- to 35-days intervals. Primary outcomes include colorimetry analysis, secondary outcomes pre- and post-photographic analysis, and DLQI quality-of-life assessment.ConclusionsThe results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.