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

November 25, 2010 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Yi-Hua Liao, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: 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
Other Names:
  • BEX-2011
Experimental: 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.
Other: 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
Other Names:
  • BEX-2011

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
the difference of darkness between the treated spots and the control spots
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

L'Oreal

Investigators

  • Principal Investigator: Yi-Hua Liao, MD, PhD, Department of Dermatology, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

November 25, 2010

First Submitted That Met QC Criteria

November 25, 2010

First Posted (Estimate)

November 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 29, 2010

Last Update Submitted That Met QC Criteria

November 25, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201003024M
  • NTUH201003024M (Registry Identifier: NTUH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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