Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma (AAI)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 19, 2009 | ||||||||
| Last Updated Date | July 14, 2010 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment [ Time Frame: 3 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00848458 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Physician Global Assessment, Patient Global Assessment, Overall Response Assessment [ Time Frame: 3 month ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma | ||||||||
| Official Title ICMJE | Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Patients will be randomized and allocated in concealed manner to one of the two treatment arms: AAI or topical azelaic acid cream. Azelaic acid iontophoresis treatment schedule: Patients randomized to the AAI group will receive iontophoresis with 15% azelaic acid twice weekly over a period of 12 weeks. Azelaic acid topical treatment schedule: Patients randomized to the topical treatment group will receive topical treatment with 20% azelaic acid cream twice daily over a period of 12 weeks. Besides emollients no additional specific treatments will be allowed during the study. The use of broad spectrum (UVA+UVB) sunscreen is recommended over the entire study period (9 month). Follow-up period: After 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 |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Melasma | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00848458 | ||||||||
| Other Study ID Numbers ICMJE | AAI, Eudra-CT Number:2008-003792-52 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Schmidt.JB.MD, Department of Dermatology / MUV | ||||||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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