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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00848458
First received: February 19, 2009
Last updated: July 14, 2010
Last verified: July 2010

February 19, 2009
July 14, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Recruiting
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
Female
18 Years and older
No
Contact: Oliver Schanab, MD 004340400 ext 5441 oliver.schanab@meduniwien.ac.at
Austria
 
NCT00848458
AAI, Eudra-CT Number:2008-003792-52
Yes
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