NCT01249469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 29, 2010

Status Verified

April 1, 2010

Enrollment Period

6 months

First QC Date

November 25, 2010

Last Update Submit

November 25, 2010

Conditions

Solar Lentigines

Outcome Measures

Primary Outcomes (1)

  • the mean reduction of darkness from baseline in target area after treatment

    8 weeks

Secondary Outcomes (1)

  • the difference of darkness between the treated spots and the control spots

    8 weeks

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

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

Skin whitening cosmetic product

EXPERIMENTAL

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

Interventions

skin whitening cosmetic productOTHER

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

Also known as: BEX-2011
Skin whitening cosmetic productVehicle

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

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

    PMID: 15552596BACKGROUND

Related Links

Study Officials

  • Yi-Hua Liao, MD, PhD

    Department of Dermatology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Hua Liao Liao, M.D PhD

CONTACT

886-2-23562141yihualiao@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2010

First Posted

November 29, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

November 29, 2010

Record last verified: 2010-04

Locations

TW(1)