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

NCT ID: NCT01249469

Last Updated: 2010-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

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.

Conditions

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Solar Lentigines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vehicle

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.

Group Type PLACEBO_COMPARATOR

skin whitening cosmetic product

Intervention Type OTHER

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

Skin whitening cosmetic product

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.

Group Type EXPERIMENTAL

skin whitening cosmetic product

Intervention Type OTHER

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

Interventions

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skin whitening cosmetic product

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

Intervention Type OTHER

Other Intervention Names

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BEX-2011

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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L'Oreal

INDUSTRY

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Loreal

Principal Investigators

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Yi-Hua Liao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Hua Liao Liao, M.D PhD

Role: CONTACT

Phone: 886-2-23562141

Email: [email protected]

Facility Contacts

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Yi-Hua Liao, MD, PhD

Role: primary

References

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Farris PK. Combination therapy for solar lentigines. J Drugs Dermatol. 2004 Sep-Oct;3(5 Suppl):S23-6.

Reference Type BACKGROUND
PMID: 15552596 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed

PubMed

Other Identifiers

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NTUH201003024M

Identifier Type: REGISTRY

Identifier Source: secondary_id

201003024M

Identifier Type: -

Identifier Source: org_study_id