Cutaneous Lupus Erythematosus Clinical Trial
Official title:
Single Blind, Controlled, Single-Center Study of Laser Treatment in Cutaneous Lupus Erythematosus
The purpose of using the 595 nm Vbeam Perfectaâ„¢ flashlamp-excited, pulsed dye laser in this study is to help improve study patients' skin disease. Cutaneous lupus erythematosus (CLE) often presents with disfiguring vascular lesions which are frequently difficult to treat with the available therapeutic measures, such as photoprotection, topical steroids, and antimalarials. Laser therapy provides an alternative treatment option for CLE patients. Although there has been documented experience with laser treatment in CLE patients, no study comparing treated lesions to the natural course of the disease has been conducted.
The Candela Vbeam PerfectaTM is an FDA approved 595nm Flashlamp Pulsed Dye Laser (PDL) that
is being used for the treatment of benign skin lesions. The purpose of using the PDL in this
study is to help improve study patients' skin disease. Cutaneous Lupus Erythematosus often
starts with damaging skin lesions which are frequently difficult to treat with the available
therapeutic measures. This study will use a flashlamp PDL to compare treated cutaneous
lesions and non-treated lesions. We will look at factors such as the degree of erythema
(redness of the skin), scale and hypertrophy (increase in size of skin), scarring and
dyspigmentation (abnormality in the formation or distribution of skin coloration) and make a
summary score of these factors.
It is important to note that this device currently is being used to treat patients with skin
lesions in the Department of Dermatology at the University of Pennsylvania, where this study
will be done. Although the PDL has been used to treat other patients, its use in this study
is experimental.
The PDL is considered to be the laser of choice for vascular lesions, because at wavelengths
of 585-595 nm, the laser is known to produce excellent clinical results at minimal risk to
patients. The laser has been used successfully in the treatment of port-wine stains in
children as young as 1 month of age. The PDL is designed to deliver an intense but gentle
burst of laser light to the skin. The light is absorbed by the blood vessels in the vascular
lesion, while leaving the surrounding tissue undamaged. The PDL has been used clinically for
the treatment of cutaneous lesions in childhood port-wine stains, childhood proliferative
angiomas, facial telangiectasias, poikiloderma of Civatte, nevus flammeus, capillary
hemangiomas, scars, verrucae, and lupus erythematosus. Several studies are known to have
used the 585-595nm PDL to treat cutaneous lupus erythematosus lesions.
During a period of 5 months, study patients will receive 3-5 treatments to one skin lesion
with the pulsed dye laser. Clinical follow-up examinations include photographs, clinical
assessments by a blinded physician, and pain and itch scales by the study patient. The study
requires a total of one year commitment per study patient.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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