Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
Study NCT ID:
NCT03546166
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486592', 'term': '3-ingenyl angelate'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical', 'timeFrame': '3 months'}, {'measure': 'To evaluate the efficacy, in terms of complete remission, of 2 cycles (for patients who did not respond to the first cycle) of a topical treatment with picato 0.05% gel topical', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'determine the tolerance of the treatment: complete remission after 1 cycle', 'timeFrame': '3 months', 'description': 'For patients in complete remission after 1 cycle'}, {'measure': 'determine the tolerance of the treatment: complete remission after 2 cycle', 'timeFrame': '3 months and 6 months', 'description': 'For patients in complete remission after 2 cycle'}, {'measure': 'Evaluate the tumor response according to clinical criteria', 'timeFrame': '3 months'}, {'measure': 'Evaluate the tumor response according dermoscopic,', 'timeFrame': '3 months'}, {'measure': 'Evaluate the tumor response according Optical Coherence Tomography', 'timeFrame': '3 months'}, {'measure': 'Evaluate the tumor response according ultrasound', 'timeFrame': '3 months'}, {'measure': 'Evaluate the tumor response according histology', 'timeFrame': '3 months'}, {'measure': 'Evaluate the tumor response according to clinical criteria', 'timeFrame': '6 months', 'description': 'For patients in complete remission after 2 cycle'}, {'measure': 'Evaluate the tumor response according to dermoscopic', 'timeFrame': '6 months', 'description': 'For patients in complete remission after 2 cycle'}, {'measure': 'Evaluate the tumor response according to Optical Coherence Tomography', 'timeFrame': '6 months', 'description': 'For patients in complete remission after 2 cycle'}, {'measure': 'Evaluate the tumor response according to ultrasound', 'timeFrame': '6 months', 'description': 'For patients in complete remission after 2 cycle'}, {'measure': 'Evaluate the tumor response according histology', 'timeFrame': '6 months', 'description': 'For patients in complete remission after 2 cycle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['basal cell carcinoma'], 'conditions': ['Carcinoma']}, 'referencesModule': {'references': [{'pmid': '21375515', 'type': 'BACKGROUND', 'citation': 'Ramsay JR, Suhrbier A, Aylward JH, Ogbourne S, Cozzi SJ, Poulsen MG, Baumann KC, Welburn P, Redlich GL, Parsons PG. The sap from Euphorbia peplus is effective against human nonmelanoma skin cancers. Br J Dermatol. 2011 Mar;164(3):633-6. doi: 10.1111/j.1365-2133.2010.10184.x. Epub 2011 Jan 27.'}, {'pmid': '23627639', 'type': 'BACKGROUND', 'citation': 'McKay KM, Sambrano BL, Fox PS, Bassett RL, Chon S, Prieto VG. Thickness of superficial basal cell carcinoma (sBCC) predicts imiquimod efficacy: a proposal for a thickness-based definition of sBCC. Br J Dermatol. 2013 Sep;169(3):549-54. doi: 10.1111/bjd.12402.'}, {'pmid': '19183171', 'type': 'BACKGROUND', 'citation': 'Mogensen M, Nurnberg BM, Forman JL, Thomsen JB, Thrane L, Jemec GB. In vivo thickness measurement of basal cell carcinoma and actinic keratosis with optical coherence tomography and 20-MHz ultrasound. Br J Dermatol. 2009 May;160(5):1026-33. doi: 10.1111/j.1365-2133.2008.09003.x. Epub 2009 Jan 12.'}, {'pmid': '26239203', 'type': 'RESULT', 'citation': 'Prieto-Granada C, Rodriguez-Waitkus P. Basal cell carcinoma: Epidemiology, clinical and histologic features, and basic science overview. Curr Probl Cancer. 2015 Jul-Aug;39(4):198-205. doi: 10.1016/j.currproblcancer.2015.07.004. Epub 2015 Jul 8. No abstract available.'}, {'pmid': '27932240', 'type': 'RESULT', 'citation': 'Williams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5.'}, {'pmid': '15087400', 'type': 'RESULT', 'citation': 'Ogbourne SM, Suhrbier A, Jones B, Cozzi SJ, Boyle GM, Morris M, McAlpine D, Johns J, Scott TM, Sutherland KP, Gardner JM, Le TT, Lenarczyk A, Aylward JH, Parsons PG. Antitumor activity of 3-ingenyl angelate: plasma membrane and mitochondrial disruption and necrotic cell death. Cancer Res. 2004 Apr 15;64(8):2833-9. doi: 10.1158/0008-5472.can-03-2837.'}, {'pmid': '22055282', 'type': 'RESULT', 'citation': 'Rosen RH, Gupta AK, Tyring SK. Dual mechanism of action of ingenol mebutate gel for topical treatment of actinic keratoses: rapid lesion necrosis followed by lesion-specific immune response. J Am Acad Dermatol. 2012 Mar;66(3):486-93. doi: 10.1016/j.jaad.2010.12.038. Epub 2011 Nov 4.'}, {'pmid': '22417254', 'type': 'RESULT', 'citation': 'Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.'}, {'pmid': '20546215', 'type': 'RESULT', 'citation': 'Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. Australas J Dermatol. 2010 May;51(2):99-105. doi: 10.1111/j.1440-0960.2010.00626.x.'}]}, 'descriptionModule': {'briefSummary': 'Basal cell carcinomas (BCCs) are the most common form of cancer. The treatment of BCC can be surgical or topical for the low-risk subtypes. Topical treatments used for BCC are imiquimod and photodynamic therapy (PDT). Ingenol mebutate could provide a fast and easy topical therapy for BCC. Data regarding the treatment of BCC with ingenol mebutate are still limited. The investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular BCC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Histologically confi rmed, primary, previously untreated, nodular or superfi cial basal-cell carcinoma not arising on the face or scalp, measuring 1 to 4 cm (large axis)\n\nExclusion Criteria:\n\n* Basal cell carcinomas of the scalp\n* Basal cell carcinomas recurrent, sclerodermiform, infiltrant, metatypic\n* Allergic patient to treatment products\n* Patient treated with immunosuppressants, immunomodulators, systemic cytotoxic agents or local corticosteroids applied in the CBC area during the 4 weeks prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT03546166', 'acronym': 'PICABAS', 'briefTitle': 'Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Open, Prospective, Single-center Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma', 'orgStudyIdInfo': {'id': '17-PP-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TREATMENT', 'interventionNames': ['Drug: Picato 0.05% Topical Gel']}], 'interventions': [{'name': 'Picato 0.05% Topical Gel', 'type': 'DRUG', 'description': 'apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 2 consecutive days. In case of treatment failure after 3 months, apply again on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 2 consecutive days.', 'armGroupLabels': ['TREATMENT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'University Hospital of Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Philippe BAHADORAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}