Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 10:00 AM
Study NCT ID:
NCT00848458
Status:
UNKNOWN
Last Update Posted:
2010-07-15
First Post:
2009-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAI
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Eudra-CT Number:2008-003792-52 | None | None | View |