Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-21 @ 7:52 PM
Study NCT ID:
NCT01249469
Status:
UNKNOWN
Last Update Posted:
2010-11-29
First Post:
2010-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-25', 'studyFirstSubmitDate': '2010-11-25', 'studyFirstSubmitQcDate': '2010-11-25', 'lastUpdatePostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the mean reduction of darkness from baseline in target area after treatment', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'the difference of darkness between the treated spots and the control spots', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Solar Lentigines']}, 'referencesModule': {'references': [{'pmid': '15552596', 'type': 'BACKGROUND', 'citation': 'Farris PK. Combination therapy for solar lentigines. J Drugs Dermatol. 2004 Sep-Oct;3(5 Suppl):S23-6.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'PubMed'}]}, 'descriptionModule': {'briefSummary': "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.\n\nObjective: 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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40-65 years old Asian women (skin types III to IV)\n* With ≥10 solar lentigines on the forearms or dorsum of hands\n* 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.\n\nExclusion Criteria:\n\n* 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\n* Past history of allergy to whitening cosmetic products\n* Past history of atopic dermatitis\n* Habit of going to the tanning salon or frequent sun exposure longer than 4 hours per day'}, 'identificationModule': {'nctId': 'NCT01249469', 'briefTitle': 'Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Evaluate the Lightening Effect of the Whitening Cosmetic Product BEX-2011 on Solar Lentigines by Harmonic Generation Microscopy', 'orgStudyIdInfo': {'id': '201003024M'}, 'secondaryIdInfos': [{'id': 'NTUH201003024M', 'type': 'REGISTRY', 'domain': 'NTUH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': '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.', 'interventionNames': ['Other: skin whitening cosmetic product']}, {'type': 'EXPERIMENTAL', 'label': 'Skin whitening cosmetic product', 'description': '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.', 'interventionNames': ['Other: skin whitening cosmetic product']}], 'interventions': [{'name': 'skin whitening cosmetic product', 'type': 'OTHER', 'otherNames': ['BEX-2011'], 'description': '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', 'armGroupLabels': ['Skin whitening cosmetic product', 'Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yi-Hua Liao, MD, PhD', 'role': 'CONTACT', 'email': 'yihualiao@ntu.edu.tw', 'phone': '886-2-23562141'}, {'name': 'Yi-Hua Liao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yi-Hua Liao Liao, M.D PhD', 'role': 'CONTACT', 'email': 'yihualiao@ntu.edu.tw', 'phone': '886-2-23562141'}], 'overallOfficials': [{'name': 'Yi-Hua Liao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "L'Oreal", 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Laurent GILBERT', 'oldOrganization': 'Loreal'}}}}