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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848458
First Posted: February 20, 2009
Last Update Posted: July 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
February 19, 2009
February 20, 2009
July 15, 2010
January 2009
December 2010   (Final data collection date for primary outcome measure)
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment [ Time Frame: 3 month ]
Same as current
Complete list of historical versions of study NCT00848458 on ClinicalTrials.gov Archive Site
Physician Global Assessment, Patient Global Assessment, Overall Response Assessment [ Time Frame: 3 month ]
Same as current
Not Provided
Not Provided
 
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial
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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Melasma
  • Other: Iontophoresis
    iontophoresis with 15% azelaic acid gel twice weekly
  • Other: Azelaic acid cream
    topical treatment with 20% azelaic acid cream twice daily
  • Experimental: Azelaic Acid Iontophoresis
    Intervention: Other: Iontophoresis
  • Active Comparator: Azelaic acid topical
    Intervention: Other: Azelaic acid cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
Not Provided
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00848458
AAI
Eudra-CT Number:2008-003792-52
Yes
Not Provided
Not Provided
Schmidt.JB.MD, Department of Dermatology / MUV
Medical University of Vienna
Not Provided
Principal Investigator: JB Schmidt, MD MUV
Study Director: Oliver Schanab, MD MUV
Medical University of Vienna
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP