Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT07036302
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-25
First Post:
2025-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistics staff'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-15', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-reported pain', 'timeFrame': 'Days 0, 30 and 60.', 'description': 'Evaluation by a 10 point Visual Analogue Scale. Higher values indicate worse pain experience.'}, {'measure': 'Adverse Events', 'timeFrame': 'Baseline versus 12 months after treatment', 'description': 'Self-reported and diagnosed adverse events'}], 'primaryOutcomes': [{'measure': 'Glogau scale', 'timeFrame': 'Baseline versus 3 months', 'description': 'Changes in Glogau scale (I to IV) for rejuvenation group. Higher values indicate worse aging conditions.'}, {'measure': 'Melasma index', 'timeFrame': 'baseline versus 3 months after treatment', 'description': 'Changes in 1 to 6 scores of modified Melasma Area and Severity Index (mMASI). Higher values indicate worse melasma conditions.'}, {'measure': 'Acne Scars Index', 'timeFrame': 'Baseline versus 3 months after treatment', 'description': 'Changes in Global 1 to 5 Scale for Acne Scar Severity (SCAR-S). Higher values indicate worse acne scars conditions.'}], 'secondaryOutcomes': [{'measure': 'Treatment impact on Quality of life', 'timeFrame': 'Baseline versus immediate post-treatment', 'description': 'SKINDEX-16 scores (0 to 100) after treatment. Higher values indicate worse quality of life.'}, {'measure': "Patient's satisfaction", 'timeFrame': 'Immediate post-treatment', 'description': "Evaluation of Patient Global Assessment (PtGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best patient's satisfaction."}, {'measure': "Professional's satisfaction", 'timeFrame': '3 months after treatment', 'description': "Evaluation of Physician Global Assessment (PGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best professional's satisfaction."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chemical peel', 'Er-YAG', 'ND-YAG', 'fractional laser', 'home care'], 'conditions': ['Melasma', 'Acne Scars - Mixed Atrophic and Hypertrophic', 'Resurfacing', 'Rejuvenation']}, 'descriptionModule': {'briefSummary': 'More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This study will evaluate the effects of chemical peels with 35% TCA (trichloroacetic acid) and two types of fractional laser in orofacial harmonization procedures. A sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40) will be recruited to underwent 3 consecutive treatment sections every 30 days. Besides clinical improvements, global satisfaction scale of the professional and the patient will be measured in addition to the impact of the treatment on the quality of life of the participants and the sensory experience in relation to pain. Pre- and pos-peeling home care will be provided to measure whether they influence results or not. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.', 'detailedDescription': 'More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This randomized clinical trial will evaluate the effects of chemical peel with 35% TCA (trichloroacetic acid)associated with croton oil. And to compare the results with its isolated formulation containing only 35% TCA and with two types of fractional laser (2940nm Er-YAG and 1640nm Nd-YAG) in orofacial harmonization procedures. This study will be based on a sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40). The experimental times will be day -15 (pre-treatment), day 0 (1st treatment session), day 30 (2nd treatment session), day 60 (3rd treatment session), day 70 (immediate post-treatment) and day 120 (mediate post-treatment). The primary outcomes will be the difference (pre- versus post-peeling) in the scores of Melasma (mMASI), acne scars (SCAR-S) or facial wrinkles (Glogau index), in the respective groups according to the main complaints. As secondary outcomes, the global satisfaction scale of the professional (PGA) and the patient (PtGA) will be measured; the impact of the treatment on the quality of life of the participants (SKINDEX-16) and the sensory experience in relation to pain (EVA 1 to 10). All participants, under local anesthesia (button anesthesia), will be randomized into one of three treatment groups: 35% TCA associated with croton oil (test), 35% TCA alone, Er-Yag or Nd-YAG laser (comparators). Intra- and inter-group differences will be considered statistically significant when p \\< 0.05. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women\n* aged 18 or over\n* acne scars, melasma or clear signs of photoaging and evident wrinkles\n* participants with acne scars or melasma will be included if they have never undergone treatment or if previous treatment has been ineffective.\n\nExclusion Criteria:\n\n* phototype VI\n* autoimmune and dermatological diseases\n* known allergies to the components of the formulations\n* patients who prefer other treatment options\n* history of keloids\n* pregnant women\n* breastfeeding women\n* women of childbearing age who do not adopt a valid method of contraception'}, 'identificationModule': {'nctId': 'NCT07036302', 'briefTitle': 'Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser', 'organization': {'class': 'OTHER', 'fullName': 'University of Taubate'}, 'officialTitle': 'Clinical Evaluation of Trichloroacetic Chemical Peel And Fractional Laser: Comparative Analysis Of Quantitative And Qualitative Parameters', 'orgStudyIdInfo': {'id': 'CAAE 84943324.1.0000.5501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melasma TCA associated with croton oil peel', 'description': '3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation', 'interventionNames': ['Procedure: 35% TCA combined with croton oil peel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Melasma isolate TCA peel', 'description': '3 sections every 30 days of a chemical peel containing only 35% TCA', 'interventionNames': ['Procedure: Isolate 35% TCA peel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Melasma Laser ND-YAG laser', 'description': '3 sections every 30 days of Neodymium: yttrium-aluminum-garnet (ND-YAG) laser', 'interventionNames': ['Radiation: Neodymium -YAG laser Q-switched']}, {'type': 'EXPERIMENTAL', 'label': 'Acne scars TCA associated with croton oil peel', 'description': '3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation', 'interventionNames': ['Procedure: 35% TCA combined with croton oil peel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acne scars isolate TCA peel', 'description': '3 sections every 30 days of a chemical peel containing only 35% TCA', 'interventionNames': ['Procedure: Isolate 35% TCA peel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acne scars Er-YAG laser', 'description': '3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser', 'interventionNames': ['Radiation: Erbium-YAG laser']}, {'type': 'EXPERIMENTAL', 'label': 'Facial rejuvenation TCA associated with croton oil peel', 'description': '3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation', 'interventionNames': ['Procedure: 35% TCA combined with croton oil peel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Facial rejuvenation isolate 35% TCA peel', 'description': '3 sections every 30 days of a chemical peel containing only 35% TCA', 'interventionNames': ['Procedure: Isolate 35% TCA peel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Facial wrinkles Er-YAG laser', 'description': '3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser', 'interventionNames': ['Radiation: Erbium-YAG laser']}], 'interventions': [{'name': '35% TCA combined with croton oil peel', 'type': 'PROCEDURE', 'description': '3 sections every 30 days of 35% TCA combined with croton oil peel', 'armGroupLabels': ['Acne scars TCA associated with croton oil peel', 'Facial rejuvenation TCA associated with croton oil peel', 'Melasma TCA associated with croton oil peel']}, {'name': 'Isolate 35% TCA peel', 'type': 'PROCEDURE', 'description': '3 sections every 30 days of isolate 35% TCA peel', 'armGroupLabels': ['Acne scars isolate TCA peel', 'Facial rejuvenation isolate 35% TCA peel', 'Melasma isolate TCA peel']}, {'name': 'Erbium-YAG laser', 'type': 'RADIATION', 'description': '3 sections every 30 days of Er-YAG laser', 'armGroupLabels': ['Acne scars Er-YAG laser', 'Facial wrinkles Er-YAG laser']}, {'name': 'Neodymium -YAG laser Q-switched', 'type': 'RADIATION', 'description': '3 sections every 30 days of ND-YAG laser', 'armGroupLabels': ['Melasma Laser ND-YAG laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12010-700', 'city': 'Taubaté', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Cavalca & Cortelli Research Center', 'geoPoint': {'lat': -23.02639, 'lon': -45.55528}}, {'zip': '12020-330', 'city': 'Taubaté', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Taubate Dental School', 'geoPoint': {'lat': -23.02639, 'lon': -45.55528}}], 'overallOfficials': [{'name': 'Sheila C Cortelli, Doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Taubate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only not identified data will be shared within research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Roberto Cortelli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cavalca & Cortelli private research center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Doctorate', 'investigatorFullName': 'Jose Roberto Cortelli', 'investigatorAffiliation': 'University of Taubate'}}}}