Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011 on Solar Lentigines by Harmonic Generation Microscopy

Conditions
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Solar Lentigines

Intervention / Treatment
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* Other: skin whitening cosmetic product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40-65 years old Asian women (skin types III to IV) With ≥10 solar lentigines on the forearms or dorsum of hands With at least one to three lesions ≥4 mm on the left or right forearm/ dorsum of hand, respectively, which are flat and are at the same pigmentation degree according to the color chart. Exclusion Criteria: Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electrosurgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study Past history of allergy to whitening cosmetic products Past history of atopic dermatitis Habit of going to the tanning salon or frequent sun exposure longer than 4 hours per day

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Product application: twice a day in the morning and before sleep for 8 weeks; from D1 to D55, but no application on D27 at night/ D28 in the morning and D55 at night/ D56 in the morning before visit. The product is applied on one side of the hand. | Other: skin whitening cosmetic product<br>* Product application: twice a day in the morning and before sleep for 8 weeks; from D1 to D55, but no application on D27 at night/ D28 in the morning and D55 at night/ D56 in the morning before visit. The product is applied on one side of the hand<br>* Other names: BEX-2011;|
| Experimental: Skin whitening cosmetic product<br>Product application: twice a day in the morning and before sleep for 8 weeks; from D1 to D55, but no application on D27 at night/ D28 in the morning and D55 at night/ D56 in the morning before visit. The product is applied on one side of the hand. | Other: skin whitening cosmetic product<br>* Product application: twice a day in the morning and before sleep for 8 weeks; from D1 to D55, but no application on D27 at night/ D28 in the morning and D55 at night/ D56 in the morning before visit. The product is applied on one side of the hand<br>* Other names: BEX-2011;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean reduction of darkness from baseline in target area after treatment |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference of darkness between the treated spots and the control spots |  | 8 weeks |