Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-11 @ 11:41 AM
Study NCT ID:
NCT06214559
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2023-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014860', 'term': 'Warts'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manon.laune@cpt.eurofinseu.com', 'phone': '+33 (0)4 72 82 36 56', 'title': 'Project Manager', 'organization': 'Eurofins Dermscan Pharmascan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '35 days', 'description': 'No adverse event occured during the study. All adverse evnet were monitored during the study', 'eventGroups': [{'id': 'EG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diameter of the Wart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 35', 'description': 'Clinical examination performed by the investigator to evaluate the diameter of the wart at D0 and 35 days after treatment.\n\nThe effect of the product on clinical parameters will be evaluated by comparing the mean diameter before and after treatment.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'On ITT population'}, {'type': 'SECONDARY', 'title': 'Global Improvement of the Wart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'title': 'Beginning of improvement', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Significant improvement', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Total recovery', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 35', 'description': 'The global improvement of the wart will be assessed by the investigator after 35 days of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'On per protocol population'}, {'type': 'SECONDARY', 'title': 'Roughness of the Wart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 35', 'description': 'The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. This outcome was measured using a scale from 0 (No roughness) to 5 (very severe roughness).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'On per protocol population'}, {'type': 'SECONDARY', 'title': 'Thickness of the Wart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 35', 'description': 'The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. This outcome was measured using a scale form 0 (no tickness) to 4(Very severe)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'On per protocol population'}, {'type': 'SECONDARY', 'title': 'Number of Dermal Papillae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.1', 'spread': '3.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 35', 'description': 'The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.', 'unitOfMeasure': 'number of dermal papillae', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'On per protocol population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Participated in Photography Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, Day 35', 'description': 'Illustration of the effectiveness of Sérum VERRUPRO® on the skin aspect before and after the treatment with photographs. A standardized photographs was taken at D0 an D35 in order to illustrate the effect of the product. No data were measured on these pictures.\n\nNumber of Participants Who Participated in Photography Session', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only photographs for illustration, no data analysed. Number of Participants Who Participated in Photography Session'}, {'type': 'SECONDARY', 'title': 'Patient Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'title': 'totally agree', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'agree', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'neutral', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'disagree', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'totally disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 35', 'description': 'Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'On per protocol population, are you globally statisfied with the product'}, {'type': 'SECONDARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, Day 35', 'description': 'Products safety will be assessed by collection of Adverse Events (AEs) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No adverse event during the study'}, {'type': 'SECONDARY', 'title': 'Product Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Very mild', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, Day 35', 'description': 'Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'on per protocol population, evaluation of local tolerance on redness / edema / Desquamation and dryness. here is presented redness at D35'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment in two private prictise in Tunisia from 19.02.2024 to 16.07.2024', 'preAssignmentDetails': 'Not applicable. No enrolled patient were excluded from the study before groups assignments'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Serum VERRUPRO', 'description': 'To be applied twice a day\n\nSérum VERRUPRO: To be applied twice a day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '36.15', 'spread': '14.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tunisia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-27', 'size': 183967, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-27T09:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2023-12-28', 'resultsFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-27', 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter of the Wart', 'timeFrame': 'Day 0, Day 35', 'description': 'Clinical examination performed by the investigator to evaluate the diameter of the wart at D0 and 35 days after treatment.\n\nThe effect of the product on clinical parameters will be evaluated by comparing the mean diameter before and after treatment.'}], 'secondaryOutcomes': [{'measure': 'Global Improvement of the Wart', 'timeFrame': 'Day 35', 'description': 'The global improvement of the wart will be assessed by the investigator after 35 days of treatment.'}, {'measure': 'Roughness of the Wart', 'timeFrame': 'Day 0, Day 35', 'description': 'The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. This outcome was measured using a scale from 0 (No roughness) to 5 (very severe roughness).'}, {'measure': 'Thickness of the Wart', 'timeFrame': 'Day 0, Day 35', 'description': 'The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment. This outcome was measured using a scale form 0 (no tickness) to 4(Very severe)'}, {'measure': 'Number of Dermal Papillae', 'timeFrame': 'Day 0, Day 35', 'description': 'The effect of the product on these clinical parameters will be evaluated by a comparison before and after treatment.'}, {'measure': 'Number of Participants Who Participated in Photography Session', 'timeFrame': 'Day 0, Day 35', 'description': 'Illustration of the effectiveness of Sérum VERRUPRO® on the skin aspect before and after the treatment with photographs. A standardized photographs was taken at D0 an D35 in order to illustrate the effect of the product. No data were measured on these pictures.\n\nNumber of Participants Who Participated in Photography Session'}, {'measure': 'Patient Evaluation', 'timeFrame': 'Day 35', 'description': 'Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 35 days after treatment.'}, {'measure': 'Adverse Event', 'timeFrame': 'Day 0, Day 35', 'description': 'Products safety will be assessed by collection of Adverse Events (AEs) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics.'}, {'measure': 'Product Tolerance', 'timeFrame': 'Day 0, Day 35', 'description': 'Product tolerance will be assessed by the investigator at D0 (before the product use) and D35 by a clinical examination.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Warts', 'Plantar Wart', 'Common Wart']}, 'descriptionModule': {'briefSummary': 'The principal aim of this study is to evaluate the efficacy and the safety of the tested product on common and plantar wart after 35 days of treatment.\n\nFor this study, 33 patients presenting at least one common wart on the fingers, back on the hand or a plantar wart of a size between 0.1 and 0.5cm and present since less than 6 months will be included to reach this objective', 'detailedDescription': 'Warts are the cutaneous manifestations of human papillomavirus (HPV). (1) Cutaneous warts are benign, spontaneously regressing, epithelial tumors differing in clinical morphology depending on the human papilloma virus HPV-types. (2) Warts may exist in different forms given the epithelial surface and HPV type responsible for the infection. Common warts (Verruca vulgaris), plantar warts (Verruca plantaris), flat or planar warts (Verruca plana), and genital warts (Condyloma acuminata) are some of the clinical manifestations of HPV infection. (1) Warts are most common on your hands, feet, and face. (3)\n\nWarts are common worldwide and affect approximately 10% of the population. In school-aged children, the prevalence is as high as 10% to 20% (4). The range of greatest incidence is between 12 and 16 years of age. (1) It is known that nearly two-thirds of warts spontaneously disappear within 24 months. (4)\n\nThe majority of warts do not cause symptoms. However, they do cause cosmetic disfigurement and, in a rare patient, may cause localized pain. Plantar warts can be painful because of compression and extensive friction that can lead to bleeding. (4) Once the diagnosis is made, the treatment depends on symptoms, patient preferences, and cost. Even though there are many treatments for warts, none is very effective, and recurrences are common with each of them. (4) This is why, developing a product that is effective against warts seems necessary.\n\nPODERM Professional has developed an innovative wart-treatment formula based on biomimetics. The principal aim of this study is to evaluate the efficacy and the safety of the tested product on common and plantar wart after 35 days of treatment. For this study, 33 patients presenting at least one common wart on the fingers, back on the hand or a plantar wart of a size between 0.1 and 0.5cm and present since less than 6 months will be included to reach this objective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient having given freely her/his informed, written consent. Patient having a good general health. Age: more than 18 years. Patient cooperative and aware of the device's modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.\n\nPatient being psychologically able to understand information and to give his/her consent.\n\nPatient presenting at least 1 common wart, present since less than 6 months, on the fingers, back of the hands (60% of patients) and/or at least 1 plantar wart (40% of patients).\n\nPatient presenting wart of a size between 0,1 and 0,5 cm. Women of childbearing potential should use an accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study and during all the study.\n\nExclusion Criteria:\n\nFor plantar wart: wart on the point of support. Wart with keratosis. Wart in mosaic. Pregnant or nursing woman or planning a pregnancy during the investigation. Patient considered by the investigator likely to be non-compliant with the protocol.\n\nPatient enrolled in another clinical trial during the test period. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.\n\nPatient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.\n\nPatient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, immunocompromised patient HIV, psoriasis, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth … Patient with cutaneous pathology on studied zone other than warts."}, 'identificationModule': {'nctId': 'NCT06214559', 'briefTitle': 'Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Swiss Footcare Laboratories - Poderm Professional'}, 'officialTitle': 'Prospective Multicentric, Before After Study to Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.', 'orgStudyIdInfo': {'id': '23E2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serum VERRUPRO', 'description': 'To be applied twice a day', 'interventionNames': ['Device: Sérum VERRUPRO']}], 'interventions': [{'name': 'Sérum VERRUPRO', 'type': 'DEVICE', 'description': 'To be applied twice a day', 'armGroupLabels': ['Serum VERRUPRO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1082', 'city': 'Tunis', 'country': 'Tunisia', 'facility': "L'Activité Privée Complémentaire (APC) Habib Thameur hospital", 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'zip': '2074', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Private practice', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Footcare Laboratories - Poderm Professional', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}