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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
L'Oreal
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01249469
First received: November 25, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Solar Lentigines
 Other: skin whitening cosmetic product

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011 on Solar Lentigines by Harmonic Generation Microscopy

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics Rashes
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the mean reduction of darkness from baseline in target area after treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the difference of darkness between the treated spots and the control spots [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BEX-2011

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249469

Contacts
Contact: Yi-Hua Liao Liao, M.D PhD 886-2-23562141 yihualiao@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yi-Hua Liao, MD, PhD     886-2-23562141     yihualiao@ntu.edu.tw    
Principal Investigator: Yi-Hua Liao, MD, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
L'Oreal
Investigators
Principal Investigator: Yi-Hua Liao, MD, PhD Department of Dermatology, National Taiwan University Hospital
  More Information

Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Laurent GILBERT, Loreal
ClinicalTrials.gov Identifier: NCT01249469     History of Changes
Other Study ID Numbers: 201003024M, NTUH201003024M
Study First Received: November 25, 2010
Last Updated: November 25, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Lentigo
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013