MelanosisPhase 4NCT00927771
Azelaic Acid Versus Hydroquinone in Melasma
A Phase 4 study testing azelaic acid gel and hydroquinone cream in people with Melanosis, run by Callender Center for Clinical Research at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Melanosis
- What is being tested?
- azelaic acid gel and hydroquinone cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 4
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have stable moderate-severe epidermal or mixed melasma involving the face
- all races
- males and females
- persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months
Who cannot join
- if the person has only dermal melasma
- pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant
- a known allergy or sensitivity ot azelaic acid or hydroquinone
- the use of photosensitizing medications (ex. tetracycline) within 3 months of the study.
- starting or stopping hormonal medication within 3 months
- chemical peels, microdermabrasion, or laser treatment within 6 months
- worsening or improving melasma
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Callender Center for Clinical Research
Mitchellville, Maryland, 20721
Tracy Brooks, 301-249-0970, clinicalresearch@callenderskin.com
Valerie D Callender, MD
About this study
Official title: Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.
Read the detailed description
Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.
- Conditions
- Melanosis
- Being tested
- azelaic acid gel, hydroquinone cream
- Keywords
- melanosis, melasma, azelaic acid, hydroquinone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azelaic acid gelDrug
Also called Finacea Gel
azelaic acid 15% gel twice a day for 6 months
hydroquinone creamDrug
Also called Claripel, Lustra
hydroquinone 4% cream twice a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Azelaic Acid | Experimental | Not described Receives: Drug: azelaic acid gel |
| Hydroquinone | Active comparator | Not described Receives: Drug: hydroquinone cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of melasma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Callender Center for Clinical Research
- Sponsor type
- University, hospital or other
- Investigators
- Valerie D Callender, MD, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927771
- Sponsor's protocol ID
- 09-01-01
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT00927771
- Acronym / sponsor ID
- 09-01-01
- Conditions
- Melanosis
- Keywords
- melanosis, melasma, azelaic acid, hydroquinone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Callender Center for Clinical ResearchUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Jun 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 study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.
Detailed description
Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelaic Acid | Experimental | Drug: azelaic acid gel |
| Hydroquinone | Active comparator | Drug: hydroquinone cream |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must have stable moderate-severe epidermal or mixed melasma involving the face
- all races
- males and females
- persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months
Key exclusion criteria (7 listed)
- if the person has only dermal melasma
- pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant
- a known allergy or sensitivity ot azelaic acid or hydroquinone
- the use of photosensitizing medications (ex. tetracycline) within 3 months of the study.
- starting or stopping hormonal medication within 3 months
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 |
|---|---|---|
| azelaic acid gelAlso: Finacea Gelazelaic acid 15% gel twice a day for 6 months | Drug | Azelaic Acid |
| hydroquinone creamAlso: Claripel, Lustrahydroquinone 4% cream twice a day for 6 months | Drug | Hydroquinone |
Primary outcome
Improvement of melasma
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
- Home page to the Callender Skin \& Laser Center that includes the link "Research Studies" to the research pageLink provided by the sponsor.
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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.
Valerie D Callender, MD principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing azelaic acid gel and hydroquinone cream in people with Melanosis, run by Callender Center for Clinical Research at 1 site in United States.
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 7 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 25 Jun 2009. 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Tracy Brooks (301.249.0970, clinicalresearch@callenderskin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of melasma (time frame: 6 months). 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 25 Jun 2009.