MelasmaPhase 2/3AAINCT00848458
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
A Phase 2/3 study testing Iontophoresis and Azelaic acid cream in people with Melasma, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Melasma
- What is being tested?
- Iontophoresis and Azelaic acid cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman
- MASI - Score over 6
- Age: over 18 years
- Skin Type: III, IV, V
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna / Depatment of Dermatology
Vienna, 1180
Oliver Schanab, MD, 004340400 ext. 5441, oliver.schanab@meduniwien.ac.at
JB Schmidt, MD
About this study
Official title: Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial
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.
Read the 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
- Conditions
- Melasma
- Being tested
- Iontophoresis, Azelaic acid cream
- Keywords
- Azelaic Acid, Iontophoresis
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IontophoresisOther
iontophoresis with 15% azelaic acid gel twice weekly
Azelaic acid creamOther
topical treatment with 20% azelaic acid cream twice daily
| Study group | Role | What they receive |
|---|---|---|
| Azelaic Acid Iontophoresis | Experimental | Not described Receives: Other: Iontophoresis |
| Azelaic acid topical | Active comparator | Not described Receives: Other: Azelaic acid cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment
Measured: 3 month
Secondary outcomes (1)
Physician Global Assessment, Patient Global Assessment, Overall Response Assessment
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- JB Schmidt, MD, Principal investigator, MUVOliver Schanab, MD, Study director, MUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848458
- Sponsor's protocol ID
- AAI
- Other IDs
- Eudra-CT Number:2008-003792-52
- Acronym
- AAI
- Status last verified
- Jul 2010
- First submitted
- 19 Feb 2009
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT00848458
- Acronym / sponsor ID
- AAI / AAI
- Conditions
- Melasma
- Keywords
- Azelaic Acid, Iontophoresis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelaic Acid Iontophoresis | Experimental | Other: Iontophoresis |
| Azelaic acid topical | Active comparator | Other: Azelaic acid cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman
- MASI - Score over 6
- Age: over 18 years
- Skin Type: III, IV, V
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresisiontophoresis with 15% azelaic acid gel twice weekly | Other | Azelaic Acid Iontophoresis |
| Azelaic acid creamtopical treatment with 20% azelaic acid cream twice daily | Other | Azelaic acid topical |
Primary outcome
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment
Time frame: 3 month
1 secondary outcome
Physician Global Assessment, Patient Global Assessment, Overall Response Assessment
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JB Schmidt, MD principal investigator
MUV
Oliver Schanab, MD study director
MUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Iontophoresis and Azelaic acid cream in people with Melasma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Schanab, MD (004340400 ext. 5441, oliver.schanab@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2010.