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

NCT ID: NCT00848458

Last Updated: 2010-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Azelaic Acid Iontophoresis

Group Type EXPERIMENTAL

Iontophoresis

Intervention Type OTHER

iontophoresis with 15% azelaic acid gel twice weekly

Azelaic acid topical

Group Type ACTIVE_COMPARATOR

Azelaic acid cream

Intervention Type OTHER

topical treatment with 20% azelaic acid cream twice daily

Interventions

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Iontophoresis

iontophoresis with 15% azelaic acid gel twice weekly

Intervention Type OTHER

Azelaic acid cream

topical treatment with 20% azelaic acid cream twice daily

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Department of Dermatology / MUV

Principal Investigators

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JB Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

MUV

Oliver Schanab, MD

Role: STUDY_DIRECTOR

MUV

Locations

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Medical University Vienna / Depatment of Dermatology

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Oliver Schanab, MD

Role: CONTACT

004340400 ext. 5441

Facility Contacts

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Oliver Schanab, MD

Role: primary

004340400 ext. 5441

Other Identifiers

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Eudra-CT Number:2008-003792-52

Identifier Type: -

Identifier Source: secondary_id

AAI

Identifier Type: -

Identifier Source: org_study_id

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