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

July 14, 2010 updated by: Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1180
        • Recruiting
        • Medical University Vienna / Depatment of Dermatology
        • Contact:
        • Principal Investigator:
          • JB Schmidt, MD
        • Sub-Investigator:
          • Oliver Schanab, MD
        • Sub-Investigator:
          • Anna Pinkowicz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician Global Assessment, Patient Global Assessment, Overall Response Assessment
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: JB Schmidt, MD, MUV
  • Study Director: Oliver Schanab, MD, MUV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2010

Last Update Submitted That Met QC Criteria

July 14, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAI
  • Eudra-CT Number:2008-003792-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melasma

Clinical Trials on Iontophoresis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe