Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 7:29 PM
Study NCT ID:
NCT04806594
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2020-11-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D002921', 'term': 'Cicatrix'}], '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': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sdipalma@relifecompany.it', 'phone': '055 56809345', 'title': 'Clinical Trial Coordinator', 'organization': 'Relife Srl'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All subjects enrolled were treated with PAPIX ACNE SCARS for 8 weeks', 'description': 'Only one adverse event was registered during the study. The event was not related to the study treatment (mild foot contusion).', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Population)', 'description': 'To evaluate the local and general tolerability of PAPIX ACNE SCAR. Adverse events and adverse reactions were recorded and evaluated.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 1, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild foot contusion).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2.6'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype', 'description': 'Papix acne scar gel for 8 consecutive weeks, 2 times per day\n\nPapix acne scar: PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'four weeks of treatment', 'description': 'The primary endpoint will be the proportion of subjects with acne scars and marks improved with respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment (treatment success). The improvement of acne scars and marks will be assessed as the change of at least one grade in the qualitative Scar Global Assessment (SGA) by Goodman and Baron between baseline and Week 4. The number of new acne scars will be assessed by count and comparison with baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS population: Per-Protocol analysis set (PPAS): all patients of the FAS who also meet all inclusion/exclusion criteria and who do not have any major protocol deviation (i.e. wrong inclusion, use of forbidden concomitant medications, etc.).'}, {'type': 'SECONDARY', 'title': 'Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Proportion of Subjects With Improved Acne Scars and Marks at Week 2 and 8 of Treatment', 'description': 'To evaluate the performance of PAPIX ACNE SCAR in the prevention and improvement of acne scars after 2 and 8 weeks of treatment. This endpoint will be assessed as the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) between baseline and Week 2 and 8. The number of acne scars, to identify any new scars, will be assessed through the scars count and comparison with baseline.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'two weeks of treatment and 8 weeks of treatment, week 8 reported', 'description': 'Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol analysis set (PPAS): all patients of the FAS who also meet all inclusion/exclusion criteria and who do not have any major protocol deviation (i.e. wrong inclusion, use of forbidden concomitant medications, etc.).'}, {'type': 'SECONDARY', 'title': 'Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Facial Acne Lesions With Respect to Baseline at Week 2, 4 and 8 of Treatment', 'description': 'To evaluate the performance of PAPIX ACNE SCAR in the prevention of acne lesions after 2, 4 and 8 weeks of treatment. The number of acne lesions, to identify any new lesions, will be assessed through the lesions count and comparison with baseline.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assested at two weeks, 4 weeks and 8 weeks, week 8 reported', 'description': 'Proportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acne Investigator Global Assessment (IGA) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change From Baseline (Visit 1) to Each Time Point (Visit 2, 3 and 4) in the Acne Severity', 'description': 'To evaluate the improvement in acne severity after 2 weeks (visit 2), 4weeks (visit 3) and 8 weeks (visit 4) of treatment, through the Investigator Global Assessment, ranging from 0 (clear; clear skin with no lesions) to 4 (severe; many inflammatory and non- inflammatory lesions).'}], 'classes': [{'title': 'Change of IGA from baseline to Visit 2 (2 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Change of IGA from baseline to Visit 3 (4 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Change of IGA from baseline to Visit 4 (8 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)', 'description': 'To evaluate acne severity after 2 weeks (visit 2), 4weeks (visit 3) and 8 weeks (visit 4) of treatment, through the Investigator Global Assessment.\n\nAcne Investigator Global Assessment (IGA). Five different grades were used to define the acne severity: 0 Clear, 1 Almost Clear, 2 Mild, 3 Moderate, 4 Severe;', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to protocol deviation some subjects were not included in all outcome'}, {'type': 'SECONDARY', 'title': 'Change of Skin Roughness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change From Baseline (Visit 1) to Each Following Time Point in the Skin Roughness', 'description': 'To evaluate the improvement of the skin roughness on a 4-point scale from 0 (none; very smooth) to 3 (severe; very rough) after 2, 4 and 8 weeks of treatment.'}], 'classes': [{'title': 'Change of skin roughness assessment from baseline to Visit 2 (2 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Change of skin roughness assessment from baseline to Visit 3 (4 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Change of skin roughness assessment from baseline to Visit 4 ( 8 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)', 'description': 'To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment Acne Investigator Global Assessment (IGA)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to protocol deviation some subjects were not included in all outcome'}, {'type': 'SECONDARY', 'title': 'Number of Partecipants With Skin Texture Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change From Baseline (Visit 1) to Each Time Point (Visit 2, 3 and 4) in the Skin Texture', 'description': 'Change from baseline (Visit 1) to each time point (Visit 2, 3 and 4) in the skin texture on a 6-point scale from 0 (worse) to 5 (complete improvement).'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assested at two weeks, 4 weeks and 8 weeks, week 8 reported', 'description': 'To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Partecipants Compliant to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Subject's Adherence to Treatment", 'description': 'The number of applications will be self-reported by the subject to assess adherence to treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': "To evaluate the subject's adherence to treatment by the product accountability.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject and Investigator Global Evaluation of Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Subject's and Investigator's Global Evaluation of Satisfaction", 'description': "Subject's and Investigator's global evaluation on performance of the study product at the end of the study (Visit 4) by means of a 7-items scale."}], 'classes': [{'title': "Subject's global evaluation of performance", 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Minimally improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': "Investigator's global evaluation of performance", 'categories': [{'title': 'Very much improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Minimally improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks of treatment ( visit 4)', 'description': "To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Subject's Overall Acceptability of the Treatment,", 'description': "Subject's overall acceptability of the treatment at the end of the study (Visit 4) by means of a 5-item scale."}], 'classes': [{'categories': [{'title': 'Very much satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Satisfied', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very much dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks of treatment ( visit 4)', 'description': "To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Partecipants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adverce Events', 'description': 'To evaluate the local and general tolerability of PAPIX ACNE SCAR. Adverse events and adverse reactions will be recorded and evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'two weeks, 4 weeks and 8 weeks of treatment', 'description': 'To evaluate the local and general tolerability of PAPIX ACNE SCAR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.', 'description': 'Papix acne scar gel for 8 consecutive weeks, 2 times per day\n\nPAPIX ACNE SCAR was topically applied twice a day for 8 weeks, 2 FTU (finger-tip units) in the morning and in 2 FTU the evening before bedtime, on the face, and massaged gently into the skin until absorbed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Did never apply the study product and did not attend following visits.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.', 'description': 'Patients will be instructed to use PAPIX ACNE SCAR applied twice a day, in the morning and in the evening before bedtime, and massaged gently into the skin until absorbed. PAPIX ACNE SCAR shall be applied only on the lesions, where possible. The treatment duration will be of 8 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%).', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The clinical investigation involved two clinical sites, the coordinating site (site 01) IRCCS San Martino - Genova - P.I. Prof. Aurora Parodi and the satellite site (site 02) IRCCS Gaslini - Genova - P.I. Prof. Corrado Ocella. Both clinical sites were allocated in Liguria (Italy)', 'unitOfMeasure': 'Participants'}, {'title': 'Subjects had clinical diagnosis of mild to moderate acne vulgaris on the face', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '(IGA score 2 or 3)', 'unitOfMeasure': 'Participants'}], 'populationDescription': '39 partecipants are the FAS'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-02', 'size': 939588, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-17T02:38', 'hasProtocol': True}, {'date': '2021-11-09', 'size': 620430, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-20T05:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2020-11-13', 'resultsFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-20', 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Partecipants With Adverse Events', 'timeFrame': 'two weeks, 4 weeks and 8 weeks of treatment', 'description': 'To evaluate the local and general tolerability of PAPIX ACNE SCAR.'}], 'primaryOutcomes': [{'measure': 'Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks', 'timeFrame': 'four weeks of treatment', 'description': 'The primary endpoint will be the proportion of subjects with acne scars and marks improved with respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment (treatment success). The improvement of acne scars and marks will be assessed as the change of at least one grade in the qualitative Scar Global Assessment (SGA) by Goodman and Baron between baseline and Week 4. The number of new acne scars will be assessed by count and comparison with baseline.'}], 'secondaryOutcomes': [{'measure': 'Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment', 'timeFrame': 'two weeks of treatment and 8 weeks of treatment, week 8 reported', 'description': 'Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire'}, {'measure': 'Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment', 'timeFrame': 'assested at two weeks, 4 weeks and 8 weeks, week 8 reported', 'description': 'Proportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).'}, {'measure': 'Acne Investigator Global Assessment (IGA) Scores', 'timeFrame': 'assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)', 'description': 'To evaluate acne severity after 2 weeks (visit 2), 4weeks (visit 3) and 8 weeks (visit 4) of treatment, through the Investigator Global Assessment.\n\nAcne Investigator Global Assessment (IGA). Five different grades were used to define the acne severity: 0 Clear, 1 Almost Clear, 2 Mild, 3 Moderate, 4 Severe;'}, {'measure': 'Change of Skin Roughness', 'timeFrame': 'assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)', 'description': 'To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment Acne Investigator Global Assessment (IGA)'}, {'measure': 'Number of Partecipants With Skin Texture Improvement', 'timeFrame': 'assested at two weeks, 4 weeks and 8 weeks, week 8 reported', 'description': 'To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA).'}, {'measure': 'Number of Partecipants Compliant to Treatment', 'timeFrame': '8 weeks', 'description': "To evaluate the subject's adherence to treatment by the product accountability."}, {'measure': 'Subject and Investigator Global Evaluation of Performance', 'timeFrame': '8 weeks of treatment ( visit 4)', 'description': "To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire."}, {'measure': 'Treatment Acceptability', 'timeFrame': '8 weeks of treatment ( visit 4)', 'description': "To evaluate the subject's overall acceptability of the treatment through a specific questionnaire."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cream', 'mild moderate acne', 'Papix', 'Papix acne scar', 'acne treatment'], 'conditions': ['Acne', 'Scars']}, 'descriptionModule': {'briefSummary': 'The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks and 3 clinical follow up visits will be performed.', 'detailedDescription': 'The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks, 2 times per day into the face.\n\nThe dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;\n2. Male or female subjects aged ≥ 12 years of any race;\n3. Subjects with any Fitzpatrick skin phototype;\n4. Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;\n5. Presence of acne scars (all types included), of grade mild or moderate according to SGA;\n6. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.\n\nExclusion Criteria:\n\n1. Pregnant women\n2. Severe acne at inclusion or any acne requiring systemic treatment;\n3. Presence of facial warts or fungal infections;\n4. Active dermatitis on the face, rosacea, active herpes simplex;\n5. Keloids presence in the area to be treated or keloids development during the treatment period;\n6. History of radiation or skin tumors in the/close to the area to be treated in the past 5 years;\n7. Laser ablative procedures within the last month;\n8. Chemical peels within the last 6 months;\n9. Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks;\n10. Use of topical retinoids within 4 weeks;\n11. Use of systemic corticosteroids or antibiotics in the previous 30 days;\n12. Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months;\n13. Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months;\n14. Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start;\n15. Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;\n16. Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;\n17. Concomitant or previous participation in other interventional clinical study in the past 3 months;\n18. Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study. In case of sun exposure this shall be limited and a protection cream (SPF 50+) shall be applied."}, 'identificationModule': {'nctId': 'NCT04806594', 'briefTitle': 'Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relife S.r.l.'}, 'officialTitle': 'Open Label, Uncontrolled Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar in the Prevention and Improvement of Scars and Lesions Associated With Acne', 'orgStudyIdInfo': {'id': 'ReGl/19/PAS-Acn/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Papix acne scar', 'description': 'Papix acne scar gel for 8 consecutive weeks, 2 times per day', 'interventionNames': ['Device: Papix acne scar']}], 'interventions': [{'name': 'Papix acne scar', 'type': 'DEVICE', 'description': 'PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration', 'armGroupLabels': ['Papix acne scar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'overallOfficials': [{'name': 'Aurora Parodi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Policlinico San Martino'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relife S.r.l.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}