Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
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
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Conditions
Melasma
Intervention
Iontophoresis, Azelaic acid cream
Location
Medical University Vienna / Depatment of Dermatology
Vienna
Austria
1180
Status
Recruiting
Source
Medical University of Vienna
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00848458
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Ice Cream
A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.
Iontophoresis
Therapeutic introduction of ions of soluble salts into tissues by means of electric current. In medical literature it is commonly used to indicate the process of increasing the penetration of drugs into surface tissues by the application of electric current. It has nothing to do with ION EXCHANGE; AIR IONIZATION nor PHONOPHORESIS, none of which requires current.
Dienestrol
A synthetic, non-steroidal estrogen structurally related to stilbestrol. It is used, usually as the cream, in the treatment of menopausal and postmenopausal symptoms.
Flurandrenolone
A corticosteroid used topically in the treatment of various skin disorders. It is usually employed as a cream or an ointment, and is also used as a polyethylene tape with an adhesive. (From Martindale, The Extra Pharmacopoeia, 30th ed, p733)
Drimys
A plant genus of the family WINTERACEAE. They have leathery, elliptic-shaped leaves; red-tinged shoots; and jasmine-scented, cream-colored, 8- to 12-petaled, 2.5-centimeter (1-inch) flowers in clusters.
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