Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma (AAI)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial|
- Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- Physician Global Assessment, Patient Global Assessment, Overall Response Assessment [ Time Frame: 3 month ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: Azelaic Acid Iontophoresis||
iontophoresis with 15% azelaic acid gel twice weekly
|Active Comparator: Azelaic acid topical||
Other: Azelaic acid cream
topical treatment with 20% azelaic acid cream twice daily
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).
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848458
|Contact: Oliver Schanab, MD||004340400 ext firstname.lastname@example.org|
|Medical University Vienna / Depatment of Dermatology||Recruiting|
|Vienna, Austria, 1180|
|Contact: Oliver Schanab, MD 004340400 ext 5441 email@example.com|
|Principal Investigator: JB Schmidt, MD|
|Sub-Investigator: Oliver Schanab, MD|
|Sub-Investigator: Anna Pinkowicz, MD|
|Principal Investigator:||JB Schmidt, MD||MUV|
|Study Director:||Oliver Schanab, MD||MUV|