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Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma

Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melasma

Intervention: Iontophoresis (Other); Azelaic acid cream (Other)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
JB Schmidt, MD, Principal Investigator, Affiliation: MUV
Oliver Schanab, MD, Study Director, Affiliation: MUV

Overall contact:
Oliver Schanab, MD, Phone: 004340400, Ext: 5441, Email: oliver.schanab@meduniwien.ac.at

Summary

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.

Clinical Details

Official title: Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment

Secondary outcome: Physician Global Assessment, Patient Global Assessment, Overall Response Assessment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Oliver Schanab, MD, Phone: 004340400, Ext: 5441, Email: oliver.schanab@meduniwien.ac.at

Medical University Vienna / Depatment of Dermatology, Vienna 1180, Austria; Recruiting
Oliver Schanab, MD, Phone: 004340400, Ext: 5441, Email: oliver.schanab@meduniwien.ac.at
JB Schmidt, MD, Principal Investigator
Oliver Schanab, MD, Sub-Investigator
Anna Pinkowicz, MD, Sub-Investigator
Additional Information

Starting date: January 2009
Last updated: July 14, 2010

Page last updated: February 07, 2013

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