MelasmaPhase 3NCT01001624
Melanil in the Treatment of Melasma
A Phase 3 study testing Melanil facial cream and Hydroquinone 2% cream in people with Melasma, run by Catalysis SL at 1 site in Cuba.
Trial summary
The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melasma
- What is being tested?
- Melanil facial cream and Hydroquinone 2% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCuba
- Study dates
- Oct 2009to Nov 2010
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Melasma
- Fitzpatrick's skin types I to IV
- Signed informed consent
- Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).
Who cannot join
- Fitzpatrick's skin types V and VI
- Treatment with steroids within the duration of the clinical trial.
- Oral contraception within the duration of the clinical trial
- Usage of other cosmetics within the duration of the clinical trial
- Treatment with Clofazimine within the duration of the clinical trial
Trial locations and contacts
1 site in 1 country.
Cuba1 site
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana, La Habana, 10400
About this study
Official title: Efficacy of Melanil in the Treatment of Melasma
The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.
- Conditions
- Melasma
- Being tested
- Melanil facial cream, Hydroquinone 2% cream
- Keywords
- Cosmetic, Facial cream, Melasma, Melanil
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanil facial creamOther
Dosage commensurate with surface to be treated, Melanil facial cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Melanil facial cream.
Hydroquinone 2% creamOther
Dosage commensurate with surface to be treated, Hydroquinone 2% cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Hydroquinone 2% cream.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Melanil facial cream Receives: Other: Melanil facial cream |
| B | Active comparator | Hydroquinone 2% cream Receives: Other: Hydroquinone 2% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
Measured: 52 weeks
Secondary outcomes (2)
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
Measured: 52 weeks
Photographs, at the beginning of the study and at weeks 8, 12 and 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionNov 2010
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfredo Abreu Daniel, PhD, Principal investigator, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001624
- Sponsor's protocol ID
- CAT-0914-CU
- Status last verified
- May 2012
- First submitted
- 23 Oct 2009
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Melanil in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT01001624
- Acronym / sponsor ID
- CAT-0914-CU
- Conditions
- Melasma
- Keywords
- Cosmetic, Facial cream, Melasma, Melanil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Oct 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 the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Melanil facial creamMelanil facial cream |
| B | Active comparator | Other: Hydroquinone 2% creamHydroquinone 2% cream |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Melasma
- Fitzpatrick's skin types I to IV
- Signed informed consent
- Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).
Key exclusion criteria (5 listed)
- Fitzpatrick's skin types V and VI
- Treatment with steroids within the duration of the clinical trial.
- Oral contraception within the duration of the clinical trial
- Usage of other cosmetics within the duration of the clinical trial
- Treatment with Clofazimine within the duration of the clinical trial
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 |
|---|---|---|
| Melanil facial creamDosage commensurate with surface to be treated, Melanil facial cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Melanil facial cream. | Other | A |
| Hydroquinone 2% creamDosage commensurate with surface to be treated, Hydroquinone 2% cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Hydroquinone 2% cream. | Other | B |
Primary outcome
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
Time frame: 52 weeks
2 secondary outcomes
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
Time frame: 52 weeks
Photographs, at the beginning of the study and at weeks 8, 12 and 52.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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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.
Alfredo Abreu Daniel, PhD principal investigator
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melanil facial cream and Hydroquinone 2% cream in people with Melasma, run by Catalysis SL at 1 site in Cuba.
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 5 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: finished, as of the sponsor's last update on 4 May 2012. 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 Cuba. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52. (time frame: 52 weeks). 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 4 May 2012.