Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial

Conditions
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Melasma

Intervention / Treatment
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* Other: Iontophoresis
* Other: Azelaic acid cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman MASI - Score over 6 Age: over 18 years Skin Type: III, IV, V Exclusion Criteria: Skin Type: I, II, VI 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic Acid Iontophoresis<br> | Other: Iontophoresis<br>* iontophoresis with 15% azelaic acid gel twice weekly<br>|
| Active Comparator: Azelaic acid topical<br> | Other: Azelaic acid cream<br>* topical treatment with 20% azelaic acid cream twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment, Patient Global Assessment, Overall Response Assessment |  | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azelaic Acid, Iontophoresis