SOURCE: Barrier Therapeutics, Inc.

January 12, 2007 16:08 ET

Recent Study Shows Favorable Results of Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution for the Treatment of Solar Lentigines in Dark Skin Types

Over 80% of Subjects Showed Significant Response to Treatment

PRINCETON, NJ -- (MARKET WIRE) -- January 12, 2007 -- Currently, Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution is the only combination product approved in the United States for the treatment of solar lentigines, commonly known as "age spots," that contains two active ingredients, mequinol and tretinoin. Solar lentigines are localized, pigmented, macular lesions of the skin on the areas of the body that have been chronically exposed to sunlight and are a common dermatologic condition that affects all skin types. Often referred to as "age," "sun" or "liver" spots, solar lentigines commonly appear as medium to dark brown spots in areas on the face, hands, forearms and chest of many people in middle age and older.

Until recently, most of the therapeutic research for treating solar lentigines has focused on Caucasian patient populations due to the epidemiological data on the disease. While there have been multiple studies demonstrating that the combination of mequinol 2%, tretinoin 0.01% provides clinically significant improvement in Caucasian patients, little research has been done to evaluate its efficacy in ethnic populations or in those with darker phototypes. Now, a recent Phase 4 study has demonstrated favorable results on the efficacy, safety and tolerability of the combination solution of Solagé Topical Solution for the treatment of solar lentigines in darker skin types.

In a poster describing the Phase 4 study, the findings on the safety and tolerability of Solagé Topical Solution in darker phototypes demonstrated a favorable benefit-to-risk ratio in the treatment of solar lentigines in African American, Asian and Latin/Hispanic subjects. Over 80% of treated subjects achieved a significant response to therapy for facial and arm lesions. Additionally, the majority of subjects maintained clinical benefit during a 4-week post treatment period. These results are consistent with efficacy findings previously reported for Caucasian individuals and provide new evidence supporting the use of Solagé Topical Solution specifically in ethnic and dark-skinned populations.

The combined solution of mequinol 2%, tretinoin 0.01% found in Solagé Topical Solution provides physicians and patients with an option for treating solar lentigines that does not contain hydroquinone. Solagé Topical Solution, marketed by Barrier Therapeutics, is available by prescription only.

About Solagé

Barrier Therapeutics currently markets Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution in the United States where it is indicated for the treatment of solar lentigines and markets the product in Canada where the indication also includes use for related hyperpigmented lesions. Currently, Solagé Topical Solution is the only combination product approved for the treatment of solar lentigines. More importantly, Solagé Topical Solution has been approved as a safe and effective treatment of solar lentigines as part of a comprehensive skin care and sun avoidance program. After numerous clinical trials, Solagé Topical Solution was deemed safe for use in humans.

For more information on Solagé, contact Michael Laferrera, Vice President of Marketing and Commercial Planning at Barrier Therapeutics, at (609) 945-1242 or visit the Solagé website at

Additional data from the Phase 4 study can be found in a poster entitled "Phase 4 Trial Findings On The Safety And Tolerability of Combination Solution of Mequinol 2%/Tretinoin 0.01% In Dark Skin Types," on Barrier Therapeutics' website at The URL for the specific web page containing the poster is:

About Barrier Therapeutics

Barrier Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of products in the field of dermatology. Barrier Therapeutics currently markets three pharmaceutical products in the United States: Xolegel™ (ketoconazole, USP) Gel, 2%, for seborrheic dermatitis; Vusion™ (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment, for diaper dermatitis complicated by candidiasis; and Solagé® (mequinol 2.0%, tretinoin 0.01%) Topical Solution, for solar lentigines. Barrier Therapeutics has other product candidates in various stages of clinical development for the treatment of a range of dermatological conditions, including acne, psoriasis, onychomycosis and other fungal infections such as tinea versicolor. The company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada. More information about Barrier Therapeutics can be found on its corporate website at:

Xolegel, Vusion and Solagé are trademarks of Barrier Therapeutics, Inc.

Safe Harbor Statement

In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Barrier's current expectations or forecasts of future events. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to the marketplace acceptance of Barrier's products, Barrier's ability to execute its commercial and clinical strategy, the decisions of regulatory authorities, the results of clinical trials and strategic decisions regarding its pipeline, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in the company's Quarter Report on Form 10-Q for the quarterly period ended September 30, 2006 which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.

In addition, please note that success in earlier clinical trials does not mean that subsequent trials will confirm earlier findings. No assessment of the efficacy or safety of any product candidate can be considered definitive until all clinical trials needed to support a submission for marketing approval are complete.

Contact Information

  • Contact:
    Barrier Therapeutics, Inc.
    Tracy Henrikson
    (609) 945-2610