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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 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
History of Changes
  Purpose

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
Melasma
 Other: Iontophoresis
Other: Azelaic acid cream
 Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician Global Assessment, Patient Global Assessment, Overall Response Assessment [ Time Frame: 3 month ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848458

Contacts
Contact: Oliver Schanab, MD 004340400 ext 5441 oliver.schanab@meduniwien.ac.at

Locations
Austria
Medical University Vienna / Depatment of Dermatology Recruiting
Vienna, Austria, 1180
Contact: Oliver Schanab, MD     004340400 ext 5441     oliver.schanab@meduniwien.ac.at    
Principal Investigator: JB Schmidt, MD            
Sub-Investigator: Oliver Schanab, MD            
Sub-Investigator: Anna Pinkowicz, MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: JB Schmidt, MD MUV
Study Director: Oliver Schanab, MD MUV
  More Information

No publications provided

Responsible Party: Schmidt.JB.MD, Department of Dermatology / MUV
ClinicalTrials.gov 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
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Azelaic Acid
Iontophoresis

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Azelaic acid
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013