Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01459393
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2011-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between 5-aminolevulinic Acid Photodynamic Therapy Versus Cryotherapy for Actinic Keratosis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-10-23', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rates', 'timeFrame': '0 months (baseline), 3 months and 6 months', 'description': 'Clinical evaluation of treated area.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogic Scale Pain Score', 'timeFrame': '0 months (baseline), 3 months, 6 months', 'description': 'Pain was evaluated with a Visual Analogic Scale (blind) and a graduated scale. It was evaluated at the time 0 and 15 minutes after each intervention (Cryotherapy or PDT): at the first intervention (0 months), and at the second intervention if the residual lesion that indicates a second session (3 months).\n\nAnd at the third interwiew (6 months) there was no intervention, but the patients who was submitted to 2 interventions were requested about what intervention was more painfull (the first or the second one).'}, {'measure': 'Cosmesis analysis', 'timeFrame': '3 months, 6 months', 'description': 'Cosmesis was evaluated subjetively by the patient as one of the possibilities: aesthetic outcome awfull, bad, regular, good, excellent.\n\nCosmesis was evaluated subjetively also by the researcher as one of the possibilities: aesthetic outcome awfull, bad, regular, good, excellent.\n\nAnd there was and objective evaluation of cosmesis by the researcher, the presece or absence of one or more of these criteria: hypochromia, hyperpigmentation,hyperemia, scar.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Actinic keratosis', 'Photodynamic therapy', '5-aminolevulinic acid', 'Cryotherapy'], 'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '17190630', 'type': 'BACKGROUND', 'citation': 'Braathen LR, Szeimies RM, Basset-Seguin N, Bissonnette R, Foley P, Pariser D, Roelandts R, Wennberg AM, Morton CA; International Society for Photodynamic Therapy in Dermatology. Guidelines on the use of photodynamic therapy for nonmelanoma skin cancer: an international consensus. International Society for Photodynamic Therapy in Dermatology, 2005. J Am Acad Dermatol. 2007 Jan;56(1):125-43. doi: 10.1016/j.jaad.2006.06.006.'}, {'pmid': '11303952', 'type': 'BACKGROUND', 'citation': 'De Rosa FS, Bentley MV. Photodynamic therapy of skin cancers: sensitizers, clinical studies and future directives. Pharm Res. 2000 Dec;17(12):1447-55. doi: 10.1023/a:1007612905378.'}, {'pmid': '9612186', 'type': 'BACKGROUND', 'citation': 'Dougherty TJ. A brief history of clinical photodynamic therapy development at Roswell Park Cancer Institute. J Clin Laser Med Surg. 1996 Oct;14(5):219-21. doi: 10.1089/clm.1996.14.219. No abstract available.'}, {'pmid': '9440322', 'type': 'BACKGROUND', 'citation': 'Fink-Puches R, Hofer A, Smolle J, Kerl H, Wolf P. Primary clinical response and long-term follow-up of solar keratoses treated with topically applied 5-aminolevulinic acid and irradiation by different wave bands of light. J Photochem Photobiol B. 1997 Nov;41(1-2):145-51. doi: 10.1016/s1011-1344(97)00096-1.'}, {'pmid': '3377516', 'type': 'BACKGROUND', 'citation': 'Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.'}, {'pmid': '12775317', 'type': 'BACKGROUND', 'citation': 'Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118.'}, {'pmid': '10607353', 'type': 'BACKGROUND', 'citation': 'Glogau RG. The risk of progression to invasive disease. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):23-4. doi: 10.1067/mjd.2000.103339.'}, {'pmid': '9197826', 'type': 'BACKGROUND', 'citation': 'Jeffes EW, McCullough JL, Weinstein GD, Fergin PE, Nelson JS, Shull TF, Simpson KR, Bukaty LM, Hoffman WL, Fong NL. Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. A pilot dose-ranging study. Arch Dermatol. 1997 Jun;133(6):727-32.'}, {'pmid': '18341663', 'type': 'BACKGROUND', 'citation': 'Kaufmann R, Spelman L, Weightman W, Reifenberger J, Szeimies RM, Verhaeghe E, Kerrouche N, Sorba V, Villemagne H, Rhodes LE. Multicentre intraindividual randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities. Br J Dermatol. 2008 May;158(5):994-9. doi: 10.1111/j.1365-2133.2008.08488.x. Epub 2008 Mar 13.'}, {'pmid': '1403373', 'type': 'BACKGROUND', 'citation': 'Kennedy JC, Pottier RH. Endogenous protoporphyrin IX, a clinically useful photosensitizer for photodynamic therapy. J Photochem Photobiol B. 1992 Jul 30;14(4):275-92. doi: 10.1016/1011-1344(92)85108-7.'}, {'pmid': '7623186', 'type': 'BACKGROUND', 'citation': 'Malik Z, Kostenich G, Roitman L, Ehrenberg B, Orenstein A. Topical application of 5-aminolevulinic acid, DMSO and EDTA: protoporphyrin IX accumulation in skin and tumours of mice. J Photochem Photobiol B. 1995 Jun;28(3):213-8. doi: 10.1016/1011-1344(95)07117-k.'}, {'pmid': '17501954', 'type': 'BACKGROUND', 'citation': 'Moloney FJ, Collins P. Randomized, double-blind, prospective study to compare topical 5-aminolaevulinic acid methylester with topical 5-aminolaevulinic acid photodynamic therapy for extensive scalp actinic keratosis. Br J Dermatol. 2007 Jul;157(1):87-91. doi: 10.1111/j.1365-2133.2007.07946.x. Epub 2007 May 14.'}, {'pmid': '10607349', 'type': 'BACKGROUND', 'citation': 'Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):4-7. doi: 10.1067/mjd.2000.103342.'}, {'pmid': '19470041', 'type': 'BACKGROUND', 'citation': 'Sotiriou E, Apalla Z, Maliamani F, Zaparas N, Panagiotidou D, Ioannides D. Intraindividual, right-left comparison of topical 5-aminolevulinic acid photodynamic therapy vs. 5% imiquimod cream for actinic keratoses on the upper extremities. J Eur Acad Dermatol Venereol. 2009 Sep;23(9):1061-5. doi: 10.1111/j.1468-3083.2009.03259.x. Epub 2009 Apr 8.'}, {'pmid': '12140473', 'type': 'BACKGROUND', 'citation': 'Szeimies RM, Karrer S, Radakovic-Fijan S, Tanew A, Calzavara-Pinton PG, Zane C, Sidoroff A, Hempel M, Ulrich J, Proebstle T, Meffert H, Mulder M, Salomon D, Dittmar HC, Bauer JW, Kernland K, Braathen L. Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: A prospective, randomized study. J Am Acad Dermatol. 2002 Aug;47(2):258-62.'}, {'pmid': '17107399', 'type': 'BACKGROUND', 'citation': 'Tschen EH, Wong DS, Pariser DM, Dunlap FE, Houlihan A, Ferdon MB; Phase IV ALA-PDT Actinic Keratosis Study Group. Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J Dermatol. 2006 Dec;155(6):1262-9. doi: 10.1111/j.1365-2133.2006.07520.x.'}, {'pmid': '10188837', 'type': 'BACKGROUND', 'citation': 'Yantsos VA, Conrad N, Zabawski E, Cockerell CJ. Incipient intraepidermal cutaneous squamous cell carcinoma: a proposal for reclassifying and grading solar (actinic) keratoses. Semin Cutan Med Surg. 1999 Mar;18(1):3-14. doi: 10.1016/s1085-5629(99)80003-0.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare in a prospective and randomized way actinic keratosis treatment with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of therapeutic efficacy, pain, and cosmetic results.', 'detailedDescription': "Actinic keratosis is a skin lesion induced by chronic sun exposure with a significant prevalence and malignant potential for squamous cell carcinoma, which makes essential its treatment. Today there are several possible therapies, where cryotherapy is usually applied in our practice. Photodynamic therapy (PDT)is another method also widespread for keratosis which involves the administration of a topical precursor drug which produces endogenous photosensitising substances activated by specific light, selectively destroying the diseased tissue. This study aims to evaluate the use the drug formulation for photodynamic therapy 5-aminolevulinic acid (5-ALA) associated with dimethyl sulfoxide, comparing its efficacy with conventional cryotherapy, and also pain and cosmetic results. This project enrolled 137 outpatients from the Department of Cutaneous Oncology of Barretos Cancer Hospital - Pio XII Foundation, with symmetrical and comparable keratosis in their upper limbs. With the same patient as controls, side arm and therapy to be used were randomized: cryotherapy or photodynamic therapy. For cryotherapy was utilized bottles of liquid nitrogen (Cry-ac, 500ml); and for photodynamic therapy was utilized incoherent red light lamp with a total dosis of 37J/cm² . There was one or two sessions of each therapy , at 0 and 3 months; and three assessments for evaluation were done at 0, 3 and 6 months of onset. The evaluations on efficacy were in terms of area regression, and classified as complete response or no response. Pain was assessed by visual analogue scale, and numerical scale. Cosmesis was evaluated with the presence or not, objectively, of hyper, hypopigmentation or scar retraction. Finally, patient's preference regarding utilized therapeutics was noted by the researcher."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years.\n* Patients with actinic keratoses "symmetrical", ie, comparable in the upper limbs ( with the same grade, I, II or III).\n* Patients in accordance with informed consent.\n\nExclusion Criteria:\n\n* Patients with concomitant skin diseases, congenital or acquired (albinism, vitiligo, xeroderma, Gorlin, etc.)\n* Immunosuppression (HIV, transplanted patients, etc.)\n* Pregnancy or lactation\n* Patients who do not agree with the informed consent initially or during the protocol.\n* Presence of pigmented lesions near the keratoses.\n* Patients with porphyria.\n* Patients who have undergone less than 2 months with some kind of treatment for keratosis in the upper limbs.'}, 'identificationModule': {'nctId': 'NCT01459393', 'briefTitle': 'Comparison Between 5-aminolevulinic Acid Photodynamic Therapy Versus Cryotherapy for Actinic Keratosis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Barretos Cancer Hospital'}, 'officialTitle': 'Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis', 'orgStudyIdInfo': {'id': '5-ALAAK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-ALA Photodynamic Therapy', 'description': 'Topical application of a 2mm of thickness layer of 20% 5-aminolevulinic acid (5-ALA) associated with 20% dimethyl sulfoxide (DMSO) and 3% ethylene diamine acid (EDTA) emulsion, over the actinic keratosis lesion and over a 0,5 cm margin around it. After a 4 hours interval under light protection with plastic film and aluminum foil, the light protection and the emulsion is removed. Then the lesion is lightened with a red (630 nm) incoherent LED lamp AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway) with a total light dose of 37J/cm2.After that dressings are done and kept for 24H, and removed at patient home.', 'interventionNames': ['Drug: 5-ALA Photodynamic Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cryotherapy with liquid nitrogen', 'description': 'Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.', 'interventionNames': ['Drug: Cryotherapy with liquid nitrogen']}], 'interventions': [{'name': '5-ALA Photodynamic Therapy', 'type': 'DRUG', 'otherNames': ['AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway)'], 'armGroupLabels': ['5-ALA Photodynamic Therapy']}, {'name': 'Cryotherapy with liquid nitrogen', 'type': 'DRUG', 'otherNames': ['Cry-ac ®'], 'description': 'Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.', 'armGroupLabels': ['Cryotherapy with liquid nitrogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14.784 - 400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Barretos Cancer Hospital', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}], 'overallOfficials': [{'name': 'Catarina Robert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundação Pio XII - Hospital de Câncer de Barretos'}, {'name': 'René AC Vieira, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundação Pio XII - Hospital de Câncer de Barretos'}, {'name': 'André L Carvalho, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundação Pio XII - Hospital de Câncer de Barretos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barretos Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}