MelasmaPhase 2/3melasmaNCT00717652
Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma
A Phase 2/3 study testing arbutin, tretinoin, triamcinolone and Triluma in people with Melasma, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal 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?
- arbutin, tretinoin, triamcinolone and Triluma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Jul 2008
- 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
- Women adults aged more than 18 years;
- Patients suffering from melasma Epidermal the face of mild and moderate;
- Patients who have not done any treatment for melasma in the 3 months preceding the study;
- Patients with good mental and physical health;
- Patients who agree with the purposes of the study and sign the TCLE.
Who cannot join
- Patients with skin diseases other than melasma, which interfere in clinical evaluation as hemangiomas and queloides;
- Patients with melasma skin or mixed;
- Patients with sensitivity to agents hipopigmentantes;
- Patients with sensitivity to fotoprotetores;
- Patients who are pregnant or breastfeeding;
- Patients who, at the discretion doctor, are not able to participate in the study;
- Patients who have carried out any treatment for melasma in the 3 months preceding the study
- Patients who do not agree with the terms described in the Statement of Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In The Treatment Of Facial Melasma, Taking As Reference The Product Triluma ® (Hidroquinone, Fluoncinolone And Tretinoin).
The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma.
Read the detailed description
The melasma is a common hipermelanosis, acquired, symmetrical, with irregular occurring in areas such as photo-exposed face, forehead and temples, can affect the eyelids and tion. The facial regions most affected are: zigomatic (82.4%), parotid (64.7%), front (64.7%), mandible (35.3%) and nasal (35.3%). The injuries of melasma is variable increase of epidermal melanin and inflammatory infiltrate of mild to moderate intensity. Treatment with compounds such as hydroquinone and derivatives, tretinoin, corticosteroids moderate or combination of them all have shown good results, diminishing the training, reducing the stability and promoting the destruction of melanocytes. The primary objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) manufactured by Glenmark Laboratory, and as the comparator drug product Triluma ® (hydroquinone + fluocinolone + tretinoin), in the treatment of epidermal melasma through parameters of clinical course of the disease (improves) and its security.
Patients who are included in the study will be randomly and automatically receive one of the treatments (New association or Triluma ®), which should use for 12 weeks. The products should be applied in the regions affected once a day, during night.
The evaluation of clinical improvement, as well as security, will be held on periodic visits, as described below, which will be held the record and supply of medicines to patients.
In each visit, beyond the clinical examination of photographs and large, it filled the Area and Severity Scale (Melasma Area and Severity Index - MASI), which quantifies the melasma and will be the main tool of control of clinical improvement.
At the end of the study, data will be compared, showing no inferiority or inferiority of clinical drug testing in relation to the comparator.
- Conditions
- Melasma
- Being tested
- arbutin, tretinoin, triamcinolone, Triluma
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arbutin, tretinoin, triamcinoloneDrug
arbutin, tretinoin, triamcinolone
TrilumaDrug
Hydroquinone, Fluoncinolone, Tretinoin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | arbutin, tretinoin, triamcinolone Receives: Drug: arbutin, tretinoin, triamcinolone |
| 2 | Active comparator | Triluma Receives: Drug: Triluma |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma.
Measured: arbutin triamcinolone tretinoin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2008
- Study completionJul 2008
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717652
- Sponsor's protocol ID
- ATTGLE0508
- Acronym
- melasma
- Status last verified
- Nov 2022
- First submitted
- 15 Jul 2008
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In The Treatment Of Facial Melasma, Taking As Reference The Product Triluma ® (Hidroquinone, Fluoncinolone And Tretinoin).
- ClinicalTrials.gov ID
- NCT00717652
- Acronym / sponsor ID
- melasma / ATTGLE0508
- Conditions
- Melasma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jul 2008 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008
- First posted
- 17 Jul 2008 (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 objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma.
Detailed description
The melasma is a common hipermelanosis, acquired, symmetrical, with irregular occurring in areas such as photo-exposed face, forehead and temples, can affect the eyelids and tion. The facial regions most affected are: zigomatic (82.4%), parotid (64.7%), front (64.7%), mandible (35.3%) and nasal (35.3%). The injuries of melasma is variable increase of epidermal melanin and inflammatory infiltrate of mild to moderate intensity. Treatment with compounds such as hydroquinone and derivatives, tretinoin, corticosteroids moderate or combination of them all have shown good results, diminishing the training, reducing the stability and promoting the destruction of melanocytes. The primary objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) manufactured by Glenmark Laboratory, and as the comparator drug product Triluma ® (hydroquinone + fluocinolone + tretinoin), in the treatment of epidermal melasma through parameters of clinical course of the disease (improves) and its security.
Patients who are included in the study will be randomly and automatically receive one of the treatments (New association or Triluma ®), which should use for 12 weeks. The products should be applied in the regions affected once a day, during night.
The evaluation of clinical improvement, as well as security, will be held on periodic visits, as described below, which will be held the record and supply of medicines to patients.
In each visit, beyond the clinical examination of photographs and large, it filled the Area and Severity Scale (Melasma Area and Severity Index - MASI), which quantifies the melasma and will be the main tool of control of clinical improvement.
At the end of the study, data will be compared, showing no inferiority or inferiority of clinical drug testing in relation to the comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: arbutin, tretinoin, triamcinolonearbutin, tretinoin, triamcinolone |
| 2 | Active comparator | Drug: TrilumaTriluma |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women adults aged more than 18 years;
- Patients suffering from melasma Epidermal the face of mild and moderate;
- Patients who have not done any treatment for melasma in the 3 months preceding the study;
- Patients with good mental and physical health;
- Patients who agree with the purposes of the study and sign the TCLE.
Key exclusion criteria (8 listed)
- Patients with skin diseases other than melasma, which interfere in clinical evaluation as hemangiomas and queloides;
- Patients with melasma skin or mixed;
- Patients with sensitivity to agents hipopigmentantes;
- Patients with sensitivity to fotoprotetores;
- Patients who are pregnant or breastfeeding;
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 |
|---|---|---|
| arbutin, tretinoin, triamcinolonearbutin, tretinoin, triamcinolone | Drug | 1 |
| TrilumaHydroquinone, Fluoncinolone, Tretinoin | Drug | 2 |
Primary outcome
evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma.
Time frame: arbutin triamcinolone tretinoin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 arbutin, tretinoin, triamcinolone and Triluma in people with Melasma, run by Azidus Brasil at 1 site in Brazil.
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 5 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: paused, as of the sponsor's last update on 3 Nov 2022. 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 Brazil. 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?
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?
evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma. (time frame: arbutin triamcinolone tretinoin). 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 3 Nov 2022.