Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 2:02 PM
Study NCT ID:
NCT04597203
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial
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': 'C031927', 'term': 'hydroquinone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified melasma area and severity index score(mMASI) - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone', 'timeFrame': '6 months', 'description': 'score range 0-24'}, {'measure': 'Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma', 'timeFrame': '6 months', 'description': 'measuring in au'}, {'measure': 'Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma', 'timeFrame': '6 months', 'description': 'measuring in au'}, {'measure': 'Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma', 'timeFrame': '6 months', 'description': 'score 0 -100%'}, {'measure': 'Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma', 'timeFrame': '6 months', 'description': 'score 0 -100%'}], 'secondaryOutcomes': [{'measure': 'Safety of using combination of 755-nm picosecond alexandrite laser', 'timeFrame': '6 months', 'description': 'Monitor side effect from picesecond alexandrite laser'}, {'measure': 'Safety of using 2% hydroquinone', 'timeFrame': '6 months', 'description': 'side effect of topical 2%Hydroquinone use'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melasma']}, 'referencesModule': {'references': [{'pmid': '36345697', 'type': 'DERIVED', 'citation': 'Manuskiatti W, Yan C, Gulfan MCB, Techapichetvanich T, Wanitphakdeedecha R. Combination of a 755-nm picosecond laser and hydroquinone 2% cream versus hydroquinone 2% cream alone for the treatment of melasma: A randomized, split-face, and controlled trial. Lasers Surg Med. 2022 Dec;54(10):1245-1250. doi: 10.1002/lsm.23615. Epub 2022 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the efficacy and safety of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone compared with 2% hydroquinone alone for the treatment of melasma: A randomized split-face controlled trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female age 18-60 years\n* Melasma on both cheeks - epidermal or mixed type\n* Fitzpatrick Skin type III-V\n\nExclusion Criteria:\n\n* History of retinoid or other keratolytic drugs used within 6 months before enrolled\n* History of keloid\n* photosensitivity\n* Immunocompromised host'}, 'identificationModule': {'nctId': 'NCT04597203', 'briefTitle': 'Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial', 'orgStudyIdInfo': {'id': 'si 082/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'split face - left side', 'interventionNames': ['Device: 755-nm picosecond alexandrite laser with topical 2% hydroquinone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'split face - right side', 'interventionNames': ['Drug: topical 2% hydroquinone']}], 'interventions': [{'name': '755-nm picosecond alexandrite laser with topical 2% hydroquinone', 'type': 'DEVICE', 'description': 'treatment one side of the face with 755-nm picosecond alexandrite laser with topical 2% hydroquinone', 'armGroupLabels': ['split face - left side']}, {'name': 'topical 2% hydroquinone', 'type': 'DRUG', 'description': 'treatment one side of the face with topical 2% hydroquinone', 'armGroupLabels': ['split face - right side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Woraphong Manuskiatti, M.D.', 'role': 'CONTACT', 'email': 'doctolaser@gmail.com', 'phone': '02-419-1000'}, {'name': 'Woraphong Manuskiatti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rungsima Wanitphakdeedacha, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chadakan Yan, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Dermatology, Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'woraphong Manuskiatti, M.D.', 'role': 'CONTACT', 'email': 'doctorlaser@gmail.com', 'phone': '02-419-1000'}, {'name': 'Chadakan Yan, M.D.', 'role': 'CONTACT', 'email': 'chadakanyan4090@gmail.com', 'phone': '66882334090'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woraphong Manuskiatti, M.D.', 'investigatorAffiliation': 'Mahidol University'}}}}