Solar Lentigines Clinical Trial
Official title:
Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011 on Solar Lentigines by Harmonic Generation Microscopy
Background: Solar lentigines are a common dermatologic condition that manifest as
circumscribed single or multiple brownish macules usually located on sun-exposed skin such
as face, hands or forearms. An effective, safe, daily-use, homecare whitening product may
alleviate the cosmetic concerns for the general population. The efficacy and safety of the
previous generation BEX-2009 (Blanc Expert Spot Eraser, L'Oreal, France), a whitening
cosmetic product containing ellagic acid, salicylic acid, licorice root extract, etc., has
been established in Caucasian and Asian populations with facial solar lentigines.
Objective: The purpose of this placebo-controlled, single-center study is 1) to evaluate the
efficacy of the new generation whitening cosmetic product BEX-2011 (Ultimate Whitening Spot
Eraser, L'Oreal, France) in the improvement of solar lentigines on the dorsum of hands or
forearms, and 2) to evaluate the efficacy of BEX-2011 by harmonic generation microscopy to
obtain information of the epidermal melanin continuum, compared to other standard tools for
melanin measurement.
Method: 40 subjects, who are non-gravid women between 45 to 65 years old and need to have ≥10 solar lentigines on the forearms/hands, will be recruited. One to three flat lesions which are larger than 4 mm and with the same pigmentation intensity on the left or right forearm/hand, respectively, are designated the target lesions. However, all lesions on the randomly selected side will be treated with BEX-2011 twice a day. The opposite site will be treated with vehicle and is served as the control. Evaluation will be performed at week 0, 4 and 8. At each visit, treated and control spots as well as their surrounding spotless skin will be evaluated using Pigmentation Index Scores, VISIA-CR, SIAscope, Dermascore, and harmonic generation microscopy. Evaluation of the efficacy of whitening will be compared to the baseline and to the control area between week 0 and week 8. Safety will be assessed using clinical monitoring and adverse event reporting. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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