Clinical trial
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).
Name
ATTGLE0508
Description
The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma.
Trial arms
Trial start
2008-07-01
Estimated PCD
2008-07-01
Trial end
2008-07-01
Phase
Early phase I
Treatment
arbutin, tretinoin, triamcinolone
arbutin, tretinoin, triamcinolone
Arms:
1
Triluma
Hydroquinone, Fluoncinolone, Tretinoin
Arms:
2
Size
110
Primary endpoint
evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma.
arbutin triamcinolone tretinoin
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2022-11-03
1 organization
2 products
1 indication
Product
ArbutinIndication
MelasmaProduct
TrilumaOrganization
Azidus Brasil