Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-30 @ 9:32 PM
Study NCT ID:
NCT05327361
Status:
TERMINATED
Last Update Posted:
2024-04-03
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013473', 'term': 'Sunscreening Agents'}], 'ancestors': [{'id': 'D011837', 'term': 'Radiation-Protective Agents'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003879', 'term': 'Dermatologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'exb743@med.miami.edu', 'phone': '3052434472', 'title': 'Enzo Berardesca', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Liftactiv B3', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post Inflammatory Hyperpigmentation (PIHP) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.'}, {'id': 'OG001', 'title': 'Liftactiv B3', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.25', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '6.56', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '6.44', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '6.44', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '6', 'spread': '0', 'groupId': 'OG000'}, {'value': '6', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Post Inflammatory Hyperpigmentation (PIHP) will be evaluated using the post acne hyperpigmentation scale.\n\nThe total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales are added together to form the total score. Higher values indicate worse hyperpigmentation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants completed the the follow up (1 month, 2 month, and 3 month) visit assessments.'}, {'type': 'SECONDARY', 'title': 'Change in the Investigators Global Assessment (IGA) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.'}, {'id': 'OG001', 'title': 'Liftactiv B3', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Pigmentation will also be evaluated clinically using the Physician global assessment IGA defined as clear is 0, almost clear is 1, mild is 2, moderate is 3, severe is 4, and every severe is 5 within the treatment area.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 12 participants completed the follow up (1 month, 2 month, and 3 month) visit assessments.'}, {'type': 'SECONDARY', 'title': 'Change in Skin Condition Evaluation Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.'}, {'id': 'OG001', 'title': 'Liftactiv B3', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.33', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': "Clinical evaluation of skin condition on subject's face which includes deep wrinkles, fine lines, skin tone, skin texture, radiance and skin elasticity will be evaluated using a 10 point Likert Scale. Each of these conditions will use the same Likert Scale from 0 to 9 with the higher score indicating more severe/worse symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.'}, {'type': 'SECONDARY', 'title': 'Change in Global Efficacy Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.\n\nParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 2 months, and 3 months', 'description': 'Global efficacy of the treatment evaluated at each visit by the patient.\n\nThe measure of the global efficacy will be realized according to the Global efficacy scale which ranges from nil to excellent which will be measured from 0 (equals nil) to 4 (equals excellent).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.'}, {'type': 'SECONDARY', 'title': 'Change in Global Tolerance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.\n\nParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 2 months, and 3 months', 'description': 'Clinical tolerance global score will be assessed, on the treated area, at each visit using first a 4-point skin reaction scale which ranges from 0 which indicates no evidence of local intolerance and 4 indicates very severe signs or symptoms of intolerance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.'}, {'type': 'SECONDARY', 'title': 'Change in Cosmeticity Questionnaire and Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.\n\nParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.39', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 2 months, and 3 months', 'description': 'Subjects will be questioned about their perceived effects of the investigational product on their skin.\n\nThe cosmeticity questionnaire is a 5 point scale (1-fully disagree; 2-disagree partly; 3-no opinion; 4-agree partly; 5-fully agree).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 9 participants completed the the follow up (to 3 month) visit assessments. Oversight of translation from protocol to CRF caused this data to not be collected at 1month and 2 month time points.'}, {'type': 'SECONDARY', 'title': 'Exposome Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.\n\nParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.'}], 'classes': [{'title': '3 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 3 months', 'description': 'Subjects will be questioned about environmental influences. Count of participants completing questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Exposome questionnaire only consists of descriptive questions (used for data collection only), so reported here as number of participants that completed questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.\n\nParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '26', 'numSubjects': '13'}]}, {'type': 'Liftactiv B3', 'achievements': [{'groupId': 'FG000', 'numUnits': '26', 'numSubjects': '13'}]}, {'type': 'Control Group', 'achievements': [{'groupId': 'FG000', 'numUnits': '26', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Half face', 'preAssignmentDetails': 'Every participant enrolled (total 13) received each arm of the study with treatment arm on one side of the face, and the control arm on the other side of the face (which equates to 26 "participants" total for the arms/groups).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Liftactiv B3 and Control Group', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.\n\nLiftactiv B3: Participants will apply a dime size amount of the serum to 1 side of the face.\n\nSunscreen: Participants will apply a dime size amount of sunscreen to cover the other half of the face.\n\nParticipant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.will apply a dime size amount of sunscreen to cover the other half of the face.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-14', 'size': 357338, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-17T17:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Enrollment timeline ended', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2022-03-14', 'resultsFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-05', 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Inflammatory Hyperpigmentation (PIHP) Change', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Post Inflammatory Hyperpigmentation (PIHP) will be evaluated using the post acne hyperpigmentation scale.\n\nThe total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales are added together to form the total score. Higher values indicate worse hyperpigmentation.'}], 'secondaryOutcomes': [{'measure': 'Change in the Investigators Global Assessment (IGA) Scale', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Pigmentation will also be evaluated clinically using the Physician global assessment IGA defined as clear is 0, almost clear is 1, mild is 2, moderate is 3, severe is 4, and every severe is 5 within the treatment area.'}, {'measure': 'Change in Skin Condition Evaluation Scores', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': "Clinical evaluation of skin condition on subject's face which includes deep wrinkles, fine lines, skin tone, skin texture, radiance and skin elasticity will be evaluated using a 10 point Likert Scale. Each of these conditions will use the same Likert Scale from 0 to 9 with the higher score indicating more severe/worse symptoms."}, {'measure': 'Change in Global Efficacy Assessment', 'timeFrame': '1 month, 2 months, and 3 months', 'description': 'Global efficacy of the treatment evaluated at each visit by the patient.\n\nThe measure of the global efficacy will be realized according to the Global efficacy scale which ranges from nil to excellent which will be measured from 0 (equals nil) to 4 (equals excellent).'}, {'measure': 'Change in Global Tolerance Score', 'timeFrame': '1 month, 2 months, and 3 months', 'description': 'Clinical tolerance global score will be assessed, on the treated area, at each visit using first a 4-point skin reaction scale which ranges from 0 which indicates no evidence of local intolerance and 4 indicates very severe signs or symptoms of intolerance.'}, {'measure': 'Change in Cosmeticity Questionnaire and Acceptability', 'timeFrame': '1 month, 2 months, and 3 months', 'description': 'Subjects will be questioned about their perceived effects of the investigational product on their skin.\n\nThe cosmeticity questionnaire is a 5 point scale (1-fully disagree; 2-disagree partly; 3-no opinion; 4-agree partly; 5-fully agree).'}, {'measure': 'Exposome Questionnaire', 'timeFrame': 'Baseline and 3 months', 'description': 'Subjects will be questioned about environmental influences. Count of participants completing questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne', 'Post Inflammatory Hyperpigmentation']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiethnic subjects\n* 18 to 50 YO\n* Phototype III-VI\n* All skin types\n* 50% with sensitive skin (declarative)\n* Symmetrical mild to moderate facial post-acne PIHP lesions with IGA scale\n* Mild active acne (less than 10 retention and 5 inflammatory lesions)\n* Agreeing not to change their lifestyle during the study period.\n* Capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations.\n* Available to follow the study\n* Agreeing to participate and having signed the informed consent\n\nExclusion Criteria:\n\n* Moderate to severe active acne\n* Patients under topical or systemic retinoids\n* Patients under systemic immunosuppressants\n* Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months\n* Patients treated with facial procedures within the last 3 months\n* Pregnancy\n* Patient with a recent change in contraception (since less than 6 months)\n* Known allergy to any component of tested product\n* Not presenting with the conditions needed to comply with the protocol.\n* Unable to give their informed consent\n* Not available to follow the study in its entirety'}, 'identificationModule': {'nctId': 'NCT05327361', 'briefTitle': 'LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months', 'orgStudyIdInfo': {'id': '20211099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participant will receive sunscreen in the morning and at the beginning of the afternoon for 3 months.', 'interventionNames': ['Other: Sunscreen']}, {'type': 'EXPERIMENTAL', 'label': 'Liftactiv B3', 'description': 'Participants will undergo a wash out phase of two weeks where they regularly apply a moisturizer (Hydreane Legere) in the morning and a sunscreen in the morning and at the beginning of the afternoon. On the 3rd week, participants will apply Liftactiv B3 serum daily in the morning before sunscreen and in the evening (two applications daily) on half face for 3 months.', 'interventionNames': ['Drug: Liftactiv B3']}], 'interventions': [{'name': 'Liftactiv B3', 'type': 'DRUG', 'description': 'Participants will apply a dime size amount of the serum to 1 side of the face.', 'armGroupLabels': ['Liftactiv B3']}, {'name': 'Sunscreen', 'type': 'OTHER', 'description': 'Participants will apply a dime size amount of sunscreen to cover the other half of the face.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vichy Laboratoires', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Leigh Nattkemper', 'investigatorAffiliation': 'University of Miami'}}}}