Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains

Status Not yet recruiting

Clinical Trial Summary

Port-wine stain (PWS) is a congenital capillary malformation with an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.

Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.

In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment.

Clinical Trial Description

Port-wine stain (PWS) is a congenital capillary malformation characterized by ectatic capillaries and postcapillary venules located predominantly in the papillary and mid-reticular layers of the dermis. It has an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.

Pulsed dye laser (PDL) of 585 and 595 nm is considered to be the gold standard for treating PWS. Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. This ratio therefore represents a relatively large number of patients who may benefit from an alternative treatment modality.

Vascular-targeted photodynamic therapy (PDT) has been used to treat PWS since the 1990s. In 1990, Orenstein et al. used a chicken comb model to show that PDT can treat hypervascular dermal lesions while leaving the normal overlying epidermis completely intact. The use of vascular-targeted PDT for treating PWS was first described in 1991. PDT can theoretically target ectatic capillaries of all diameters and, in contrast to PDL, can induce vascular damage deeper in the dermis, with a considerably reduced risk of epidermal necrosis due to its vascular-selective characteristics. Previous studies have also demonstrated that PDT is an effective and safe means of improving the appearance of PWS.

Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.Therefore, the choice of early treatment for PWS is very important . The effect of PDL therapy on the follow-up photodynamic treatment of PWS unknown.

In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment. Our objectis to explore whether the previous PDL treatment will affect the efficacy of the follow-up PDT on PWS, so as to provide early treatment options for children with PWS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04536740
Study type	Interventional
Source	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact	Gang Ma
Phone	021-23271699
Email	docmagang@126.com
Status	Not yet recruiting
Phase	N/A
Start date	October 1, 2020
Completion date	September 30, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.