Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02095756
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2014-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Alexandrite Laser and Topical Therapy vs Topical Therapy Alone for Treatment of 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': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-21', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melasma clearance', 'timeFrame': 'up to 3 months post last treatment', 'description': 'Evaluate the efficacy of a combination of non-hydroquinone topical therapy and a 755-nm alexandrite laser compared to topical therapy alone in the treatment of melasma .'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of a combination of non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone for the treatment of facial melasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female Subjects aged 18-74 years of age;\n* Fitzpatrick Skin Types I-IV;\n* Female subjects of childbearing potential must have a negative urine pregnancy test at the beginning of the study, and agree to practice appropriate birth-control to prevent pregnancy during the study. The type and dose of birth control must have been stable for at least 3 months prior to study entry and it is not expected to change during the study; acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active.\n* Subjects diagnosed with moderate to severe melasma on both sides of the face\n* For subjects using medication to treat a concurrent medical condition, type and dose must have been stable for at least 3 months prior to study entry and it is not expected to change during the study (except any medications specifically outlined in the exclusion criteria section)\n* Subjects able to avoid prolonged sun exposure on the face for the duration of the study and willing to use appropriate sun avoidance techniques.\n* Subjects able to follow study instructions and likely to complete all required visits;\n* Subjects/Representative able and willing to sign the Informed Consent (which includes a photography release) prior to any study procedures.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, nursing or planning a pregnancy during the course of the study;\n* Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject's participation in the study, such as: the use of a concomitant medication that can interfere with the study or worsen any condition when used during the study, the use of medications known to induce photosensitivity;\n* Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study regimen (e.g. eczema, psoriasis, severe sun-damage, dermatitis) and/or have scarring or infection of the area to be treated;\n* Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma, etc.) in the areas to be treated;\n* Subject unwilling to avoid any other treatment for melasma during the study (total duration of 30 weeks);\n* Subjects with a wash-out period of less than 14 days for melasma treatments at the time of study entry or under current treatment;\n* Subjects with prior facial resurfacing, deep or chemical peels within 6 months of the date of study entry;\n* Subject unwilling to refrain from any facial cosmetic procedures during the study period (e.g., chemical peels, resurfacing, microdermabrasion, etc.);\n* Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study;\n* Subject has participated in a clinical research study within the last 30 days prior to enrollment;\n* Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or other reasons;\n* Subject is unable to meet the study attendance requirements."}, 'identificationModule': {'nctId': 'NCT02095756', 'briefTitle': 'Combination Alexandrite Laser and Topical Therapy vs Topical Therapy Alone for Treatment of Melasma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cynosure, Inc.'}, 'officialTitle': 'A Randomized, Split-Face, Double-Blind Clinical Pilot Study of Combination Picosecond Alexandrite Laser and Non-Hydroquinone Topical Therapy Versus Topical Therapy Alone for the Treatment of Facial Melasma', 'orgStudyIdInfo': {'id': 'PICO-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '755nm Alexandrite laser', 'description': '755nm Alexandrite laser for the treatment of melasma', 'interventionNames': ['Other: 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)', 'Other: Lytera Skin Brightening System (Non-hydroquinone topical therapy)']}], 'interventions': [{'name': '755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)', 'type': 'OTHER', 'armGroupLabels': ['755nm Alexandrite laser']}, {'name': 'Lytera Skin Brightening System (Non-hydroquinone topical therapy)', 'type': 'OTHER', 'armGroupLabels': ['755nm Alexandrite laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynosure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}