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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014