Bradley Pharmaceuticals Solaraze And TX Systems B-Lift Featured At European Dermatology Conference
FAIRFIELD, NJ - Bradley Pharmaceuticals, Inc. announced recently that two brands marketed by the Company's Doak Dermatologics subsidiary were presented recently at the 16th European Academy of Dermatology and Venerology (EADV) Conference in Vienna, Austria.
TX Systems B-Lift, licensed from Drs. Albert and Douglas Kligman, is a cosmetic formulation of salicylic acid that is used for epidermal skin peeling to improve appearance. The product was presented in a scientific session conducted by Dr. Aleksandar Krunic, Clinical Assistant Professor of Dermatology, University of Illinois College of Medicine. His study entitled, "Salicylic Acid Peels for Dyschromia, Photoaging and Acne-Related Conditions -- Our Experience," assessed the effect of salicylic acid peels in patients with darker skin types and conditions including acne, rosacea, postinflammatory hyperpigmentation, melasma, enlarged pores and photoaging.
Thirty-six adult patients participated voluntarily in the study. All other systemic and topical treatments were prohibited. The patients had undergone facial peels with 20-30% salicylic acid in a hydroethanolic solution bi-weekly for three months. They were pre-treated for two weeks with hydroquinone 4% prior to undergoing a series of five salicylic acid chemical peels. Two investigators independently evaluated patients by physical examination and comparison of pre-treatment and post-treatment photos. Paired comparisons revealed moderate to significant improvement in 80.6% of the patients, and it was concluded that salicylic acid peels are beneficial in improving the appearance of acne, dyschromia rosacea and photoaging in patients with darker skin tones.
Solaraze Gel (diclofenac sodium - 3%), indicated for the topical treatment of actinic keratosis, was featured in a scientific poster exhibit. Dr. Boni E. Elewski, professor and Director of Clinical Research, Department of Dermatology, at the University of Alabama at Birmingham and past president of the American Academy of Dermatology, presented a poster entitled, "Disseminated Superficial Actinic Porokeratosis (DSAP) Treated with Diclofenac Sodium 3% Gel." DSAP is a hereditary disorder of keratinization causing numerous dry patches on sun-exposed areas of the arms and legs.
An open-label, multi-center pilot study was initiated with 15 adult patients enrolled across four sites. Diclofenac sodium 3% gel was applied to the left or right forearm, twice daily and patients were followed monthly for 12 weeks. If lesions were still present, patients continued medication for an additional 12 weeks. Target area lesion counts were performed at each visit to objectively measure efficacy. The primary endpoint was a decrease in the number of DSAP lesions from baseline. Preliminary data from the study indicates treatment with diclofenac sodium 3% gel lead to a stable or reduced number of DSAP lesions in 5 out of 9 patients at 12 weeks. The study is still ongoing and not all patients have completed 24 weeks.
"We at Bradley are fully committed to supporting our brands with data from clinical studies," stated Daniel Glassman, President and CEO of Bradley Pharmaceuticals. "Currently there are four additional dermatology studies in progress and we look forward to the results because such studies further validate the benefits of our products and support the importance of the specialty markets we serve."
Important Product Safety Information About Solaraze Gel:
SUN AVOIDANCE IS INDICATED DURING SOLARAZE GEL THERAPY. As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. In clinical trials, the most common adverse reactions involved the skin and included contact dermatitis, rash, dry skin and exfoliation. The majority of these reactions were mild to moderate, and resolved upon discontinuation of therapy. SOLARAZE Gel should not be applied to open skin wounds, infections, or exfoliative dermatitis.
For additional important information about Solaraze Gel, you can visit: http://www.bradpharm.com.
SOURCE: Bradley Pharmaceuticals, Inc.