Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT00848458
Status:
UNKNOWN
Last Update Posted:
2010-07-15
First Post:
2009-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007478', 'term': 'Iontophoresis'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'lastUpdateSubmitDate': '2010-07-14', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment', 'timeFrame': '3 month'}], 'secondaryOutcomes': [{'measure': 'Physician Global Assessment, Patient Global Assessment, Overall Response Assessment', 'timeFrame': '3 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Azelaic Acid', 'Iontophoresis'], 'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus topical treatment with azelaic acid cream in female patients with melasma.', 'detailedDescription': 'Patients will be randomized and allocated in concealed manner to one of the two treatment arms: AAI or topical azelaic acid cream.\n\nAzelaic acid iontophoresis treatment schedule:\n\nPatients randomized to the AAI group will receive iontophoresis with 15% azelaic acid twice weekly over a period of 12 weeks.\n\nAzelaic acid topical treatment schedule:\n\nPatients randomized to the topical treatment group will receive topical treatment with 20% azelaic acid cream twice daily over a period of 12 weeks.\n\nBesides emollients no additional specific treatments will be allowed during the study.\n\nThe use of broad spectrum (UVA+UVB) sunscreen is recommended over the entire study period (9 month).\n\nFollow-up period:\n\nAfter completion of the active study period (3 month in both treatment groups), maintenance and efficacy of both treatment schedules will be followed up quarterly over 6 month'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman\n* MASI - Score over 6\n* Age: over 18 years\n* Skin Type: III, IV, V\n\nExclusion Criteria:\n\n* Skin Type: I, II, VI\n* Pregnant or lactating women\n* Local therapy of intent-to-treat area within the last 6 month\n* Patient with a pacemaker or metal implant\n* Epileptic\n* Mental incompetence to understand the protocol\n* Known allergic reactions to one of used substances\n* Serious encroachment on physical condition'}, 'identificationModule': {'nctId': 'NCT00848458', 'acronym': 'AAI', 'briefTitle': 'Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'AAI'}, 'secondaryIdInfos': [{'id': 'Eudra-CT Number:2008-003792-52'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azelaic Acid Iontophoresis', 'interventionNames': ['Other: Iontophoresis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azelaic acid topical', 'interventionNames': ['Other: Azelaic acid cream']}], 'interventions': [{'name': 'Iontophoresis', 'type': 'OTHER', 'description': 'iontophoresis with 15% azelaic acid gel twice weekly', 'armGroupLabels': ['Azelaic Acid Iontophoresis']}, {'name': 'Azelaic acid cream', 'type': 'OTHER', 'description': 'topical treatment with 20% azelaic acid cream twice daily', 'armGroupLabels': ['Azelaic acid topical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1180', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Oliver Schanab, MD', 'role': 'CONTACT', 'email': 'oliver.schanab@meduniwien.ac.at', 'phone': '004340400', 'phoneExt': '5441'}, {'name': 'JB Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oliver Schanab, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Pinkowicz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University Vienna / Depatment of Dermatology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Oliver Schanab, MD', 'role': 'CONTACT', 'email': 'oliver.schanab@meduniwien.ac.at', 'phone': '004340400', 'phoneExt': '5441'}], 'overallOfficials': [{'name': 'JB Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUV'}, {'name': 'Oliver Schanab, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MUV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Schmidt.JB.MD', 'oldOrganization': 'Department of Dermatology / MUV'}}}}