NCT00848458

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

July 15, 2010

Status Verified

July 1, 2010

Enrollment Period

1.9 years

First QC Date

February 19, 2009

Last Update Submit

July 14, 2010

Conditions

Melasma

Keywords

Azelaic AcidIontophoresis

Outcome Measures

Primary Outcomes (1)

  • Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment

    3 month

Secondary Outcomes (1)

  • Physician Global Assessment, Patient Global Assessment, Overall Response Assessment

    3 month

Study Arms (2)

Azelaic Acid Iontophoresis

EXPERIMENTAL
Other: Iontophoresis

Azelaic acid topical

ACTIVE COMPARATOR
Other: Azelaic acid cream

Interventions

IontophoresisOTHER

iontophoresis with 15% azelaic acid gel twice weekly

Azelaic Acid Iontophoresis
Azelaic acid creamOTHER

topical treatment with 20% azelaic acid cream twice daily

Azelaic acid topical

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman
  • MASI - Score over 6
  • Age: over 18 years
  • Skin Type: III, IV, V

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna / Depatment of Dermatology

Vienna, 1180, Austria

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

Iontophoresis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative Techniques

Study Officials

  • JB Schmidt, MD

    MUV

    PRINCIPAL INVESTIGATOR

  • Oliver Schanab, MD

    MUV

    STUDY DIRECTOR

Central Study Contacts

Oliver Schanab, MD

CONTACT

004340400oliver.schanab@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Last Updated

July 15, 2010

Record last verified: 2010-07

Locations

AU(1)