Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT03049059
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized split face'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified MASI score', 'timeFrame': 'The mean change from the baseline to week-12 visit'}, {'measure': 'Proportion of subjects with at least 50% MASI score improvement', 'timeFrame': 'from baseline to 12-week visit'}], 'secondaryOutcomes': [{'measure': 'Mexameter Melanin index', 'timeFrame': 'baseline, week 4, week 8 and week 12'}, {'measure': 'Global satisfaction score by Quartile rating scale', 'timeFrame': 'week 4, week 8 and week 12'}, {'measure': 'Quality of life by DLQI', 'timeFrame': 'at week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Picoseconds Laser', 'Melasma']}, 'referencesModule': {'references': [{'pmid': '7496671', 'type': 'BACKGROUND', 'citation': 'Ho C, Nguyen Q, Lowe NJ, Griffin ME, Lask G. Laser resurfacing in pigmented skin. Dermatol Surg. 1995 Dec;21(12):1035-7. doi: 10.1111/j.1524-4725.1995.tb00554.x.'}, {'type': 'BACKGROUND', 'citation': 'Weiss M, Weiss R, Lorden F, Trageser M, Beasley K. Picosecond laser for reduction of wrinkles: Long term results. Lasers Surg Med 2015; 47(S26): 24 (Abstract #68).'}]}, 'descriptionModule': {'briefSummary': 'A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma', 'detailedDescription': "Primary Objective:\n\n* To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary objectives\n* To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for pigmentation, quality of life by Dermatology Life Quality Index and patient's satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female with melasma lesion on bilateral sides\n* Age between 18-65 years\n* Dermal or mixed type melasma, confirming by Wood's lamp test\n* Willing to participant in this study and signed in informed consent form\n\nExclusion Criteria:\n\n* Pregnancy / lactation\n* Having an activity or working outside the building or unable to avoid heavy UV light\n* Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months\n* Treatment with Skin Lighting medication / food supplements within 4 weeks\n* Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks\n* Use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks\n* Uncontrolled medical illness include non-skin cancers, coagulopathy\n* Intra-cardiac device - pacemaker\n* Photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis\n* Currently taking anticoagulant such as warfarin\n* Active skin infection or acute dermatitis at testes skin sites\n* Unable to follow and comply to the study protocol"}, 'identificationModule': {'nctId': 'NCT03049059', 'briefTitle': 'A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma', 'organization': {'class': 'OTHER', 'fullName': 'Mae Fah Luang University Hospital'}, 'officialTitle': 'A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma', 'orgStudyIdInfo': {'id': '087/2559'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream', 'interventionNames': ['Device: Fractional Picosecond 1,064 nm laser', 'Drug: 4% hydroquinone cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4% hydroquinone cream alone', 'interventionNames': ['Drug: 4% hydroquinone cream']}], 'interventions': [{'name': 'Fractional Picosecond 1,064 nm laser', 'type': 'DEVICE', 'description': 'Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream', 'armGroupLabels': ['Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream']}, {'name': '4% hydroquinone cream', 'type': 'DRUG', 'armGroupLabels': ['4% hydroquinone cream alone', 'Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mae Fah Luang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Thep Chalermchai', 'investigatorAffiliation': 'Mae Fah Luang University Hospital'}}}}