Azelaic acid iontophoresis versus topical azelaic acid cream in the treatment of melasma – An open randomized, controlled, prospective, single blinded clinical trial
- Conditions
- clinical diagnosis of melasma
- Registration Number
- EUCTR2008-003792-52-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik fuer Dermatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with clinical diagnosis Melasma and a total MASI- score of at least at 6
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Skintyp I, II, VI
Man
Pregnancy and breast-feeding period
Children and adolescents under 18 years
Other Diseases topical therapies in the last 6 months
EpilepticsPatients with pacemakers or metal implants
Severe reduction in the general state of health
Mental incapacity to understand the protocol
Known allergic reactions to one of the substances used
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to compare the effect of iontophoresis with azelaic azid versus topical treatment with azelaic azid on MASI score and coloimetry in patients with melasma.;Secondary Objective: to compare the effect of iontophoresis with azelaic azid versus topical treatment with azelaic azid on Physician Global Assessment, Patient Global Assessment and Overall Response Assessment in patients with melasma.<br>;Primary end point(s): The difference in the colrimetrie or MASI-score measurement between baseline and 12-week value
- Secondary Outcome Measures
Name Time Method