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

Melasma Clinical Trial

— AAI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00848458
• Other study ID #: AAI
• Secondary ID: Eudra-CT Number:
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 19, 2009
• Last updated: July 14, 2010
• Start date: January 2009

Study information

• Verified date: July 2010
• Source: Medical University of Vienna
• Contact: Oliver Schanab, MD
• Phone: 004340400
• Email: oliver.schanab[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Melasma

Intervention

Other:
• Iontophoresis
iontophoresis with 15% azelaic acid gel twice weekly
• Azelaic acid cream
topical treatment with 20% azelaic acid cream twice daily

Locations

Country	Name	City	State
Austria	Medical University Vienna / Depatment of Dermatology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment		3 month	No
Secondary	Physician Global Assessment, Patient Global Assessment, Overall Response Assessment		3 month	No