Clinical trial NCT01249469: Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011
Official title: Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011 on Solar Lentigines by Harmonic Generation Microscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solar Lentigines
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: L'Oreal
First posted: 2010-11-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the mean reduction of darkness from baseline in target area after treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: the difference of darkness between the treated spots and the control spots
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Dermatology, National Taiwan University Hospital
name: Yi-Hua Liao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farris PK. Combination therapy for solar lentigines. J Drugs Dermatol. 2004 Sep-Oct;3(5 Suppl):S23-6.