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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00848458

Acronym

AAI

Enrollment

Registered

2009-02-20

Start date

2009-01-31

Completion date

Unknown

Last updated

2010-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

Azelaic Acid, Iontophoresis

Brief 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.

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

Interventions

OTHERIontophoresis

iontophoresis with 15% azelaic acid gel twice weekly

OTHERAzelaic acid cream

topical treatment with 20% azelaic acid cream twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Physician Global Assessment, Patient Global Assessment, Overall Response Assessment	3 month

Countries

Austria

Contacts

Primary ContactOliver Schanab, MD

oliver.schanab@meduniwien.ac.at004340400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026