Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-02-27 @ 10:37 AM
Study NCT ID:
NCT04606134
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2020-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mara_Weinsteinvelez@URMC.Rochester.edu', 'phone': '(585) 275-7546', 'title': 'Mara Weinstein MD', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'through study completion, approximately 90 days', 'description': 'Adverse event collection did not differ from the clinicaltrials.gov definition.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Melasma', 'notes': 'Melasma, flare after first treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily'}, {'id': 'OG001', 'title': 'Control', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.687', 'spread': '4.461', 'groupId': 'OG000'}, {'value': '5.730', 'spread': '4.461', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to day 34', 'description': 'A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the control group, discontinued prior to Day 30.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Skin Barrier Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily'}, {'id': 'OG001', 'title': 'Control', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily'}], 'classes': [{'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.502', 'spread': '6.650', 'groupId': 'OG000'}, {'value': '21.59', 'spread': '6.650', 'groupId': 'OG001'}]}]}, {'title': 'Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.858', 'spread': '7.233', 'groupId': 'OG000'}, {'value': '39.07', 'spread': '7.233', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to day 34', 'description': 'Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm.', 'unitOfMeasure': 'g/m^2h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the control group discontinued prior to second laser treatment, Day 30.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily'}, {'id': 'OG001', 'title': 'Control', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to day 90', 'description': 'The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the control discontinued prior to Day 90.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily'}, {'id': 'OG001', 'title': 'Control', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.768', 'spread': '4.218', 'groupId': 'OG000'}, {'value': '5.596', 'spread': '4.218', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to day 4', 'description': 'A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in the control group, discontinued prior to Day 30.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Alastin Regenerating Skin Nectar With TriHex Technology', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily'}, {'id': 'FG001', 'title': 'Control: Cetaphil', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Alastin Regenerating Skin Nectar With TriHex Technology', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nAlastin Regenerating Skin Nectar with TriHex Technology: applied twice daily'}, {'id': 'BG001', 'title': 'Control: Cetaphil', 'description': 'Hybrid fractional laser: two treatments given one month apart\n\nCetaphil face cream: applied twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '45'}, {'value': '31.5', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '45'}, {'value': '33.4', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '45'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-03', 'size': 270926, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-17T14:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2020-10-21', 'resultsFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-11', 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Erythema', 'timeFrame': 'baseline to day 34', 'description': 'A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.'}, {'measure': 'Mean Change From Baseline in Erythema', 'timeFrame': 'baseline to day 4', 'description': 'A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Skin Barrier Function', 'timeFrame': 'baseline to day 34', 'description': 'Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm.'}, {'measure': 'Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale', 'timeFrame': 'baseline to day 90', 'description': 'The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acne Scars - Mixed Atrophic and Hypertrophic']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or females\n* age 18 and older\n* with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman \\& Baron qualitative global acne scar grading system\n\nExclusion Criteria:\n\n* treatment to face with any energy device within 6 months\n* tanning within 7 days\n* dermabrasion or chemical peel within 3 months\n* current use of systemic retinoids\n* keloidal scaring in the treatment area\n* use of systemic steroids within 6 months\n* use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days'}, 'identificationModule': {'nctId': 'NCT04606134', 'briefTitle': 'Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars', 'orgStudyIdInfo': {'id': 'STUDY00003126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Device: Hybrid fractional laser', 'Other: Alastin Regenerating Skin Nectar with TriHex Technology']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Device: Hybrid fractional laser', 'Other: Cetaphil face cream']}], 'interventions': [{'name': 'Hybrid fractional laser', 'type': 'DEVICE', 'description': 'two treatments given one month apart', 'armGroupLabels': ['Control', 'Experimental']}, {'name': 'Alastin Regenerating Skin Nectar with TriHex Technology', 'type': 'OTHER', 'description': 'applied twice daily', 'armGroupLabels': ['Experimental']}, {'name': 'Cetaphil face cream', 'type': 'OTHER', 'description': 'applied twice daily', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mara Weinstein Velez, MD', 'investigatorAffiliation': 'University of Rochester'}}}}