Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
NCT ID: NCT00848458
Last Updated: 2010-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2009-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Azelaic Acid Iontophoresis
Iontophoresis
iontophoresis with 15% azelaic acid gel twice weekly
Azelaic acid topical
Azelaic acid cream
topical treatment with 20% azelaic acid cream twice daily
Interventions
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Iontophoresis
iontophoresis with 15% azelaic acid gel twice weekly
Azelaic acid cream
topical treatment with 20% azelaic acid cream twice daily
Eligibility Criteria
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Inclusion Criteria
* MASI - Score over 6
* Age: over 18 years
* Skin Type: III, IV, V
Exclusion Criteria
* Pregnant or lactating women
* Local therapy of intent-to-treat area within the last 6 month
* Patient with a pacemaker or metal implant
* Epileptic
* Mental incompetence to understand the protocol
* Known allergic reactions to one of used substances
* Serious encroachment on physical condition
18 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Department of Dermatology / MUV
Principal Investigators
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JB Schmidt, MD
Role: PRINCIPAL_INVESTIGATOR
MUV
Oliver Schanab, MD
Role: STUDY_DIRECTOR
MUV
Locations
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Medical University Vienna / Depatment of Dermatology
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Eudra-CT Number:2008-003792-52
Identifier Type: -
Identifier Source: secondary_id
AAI
Identifier Type: -
Identifier Source: org_study_id
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