Background: In a recent randomized, double-blind, placebo-controlled clinical study, the efficacy of a combination consisting of 0.25% alpha-glucosyl-rutin, 1% vitamin E and a broad-spectrum, highly UVA-protective sunscreen (sun protector factor 15 - persistent pigmentation darkening 6) regarding prevention of polymorphous light eruption was well demonstrated. We evaluated this combination under real solar exposure conditions.
Patients and methods: Patients with three previous typical polymorphous light eruptions (including one in the last year) were included in an open prospective multicenter study. The preparation was applied every two hours after the first summer exposure. No topical or systemic treatments presumed to be effective against polymorphous light eruption were given concomitantly. Evaluation was performed after the summer by a dermatologist.
Results: Two of the 54 patients dropped out of the study, one for an adverse effect (contact dermatitis). At the end of the study following application of the test preparation, no eruption was seen for 35 patients (67%), with minor eruption for 10 patients (19%) and an marked eruption for 7 patients (13%). Pruritus (present in all patients the year before) was not seen in 36 patients (69%), was considered bearable for 36 patients and unbearable for only 3 patients compared to 27 before inclusion. For the dermatologists, efficacy was excellent for 35 patients and good for 7 patients, giving global efficacy of around 80%, with inadequate results in 10% of cases (5 patients). Concerning protection against erythema, the test product reduced sunburn by 60% compared with the previous year.
Discussion: Because of the high clinical efficacy of the product noted after UVA challenge tests and verified by this clinical study under actual conditions of exposure, it may be proposed as a new prophylactic treatment for polymorphous light eruption.