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Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma (AAI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Medical University of Vienna.
Recruitment status was:  Recruiting
Information provided by:
Medical University of Vienna Identifier:
First received: February 19, 2009
Last updated: July 14, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Other: Iontophoresis
Other: Azelaic acid cream
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment [ Time Frame: 3 month ]

Secondary Outcome Measures:
  • Physician Global Assessment, Patient Global Assessment, Overall Response Assessment [ Time Frame: 3 month ]

Estimated Enrollment: 70
Study Start Date: January 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azelaic Acid Iontophoresis Other: 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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00848458

Medical University Vienna / Depatment of Dermatology
Vienna, Austria, 1180
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: JB Schmidt, MD MUV
Study Director: Oliver Schanab, MD MUV
  More Information

Responsible Party: Schmidt.JB.MD, Department of Dermatology / MUV Identifier: NCT00848458     History of Changes
Other Study ID Numbers: AAI  Eudra-CT Number:2008-003792-52 
Study First Received: February 19, 2009
Last Updated: July 14, 2010

Keywords provided by Medical University of Vienna:
Azelaic Acid

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents processed this record on February 17, 2017