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| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2008 | ||||
| Last Updated Date | July 16, 2008 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma. [ Time Frame: arbutin triamcinolone tretinoin ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00717652 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma | ||||
| Official Title ICMJE | 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). | ||||
| Brief Summary | The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Melasma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 110 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00717652 | ||||
| Responsible Party | Alexandre Frederico, LAL Clinica | ||||
| Study ID Numbers ICMJE | ATTGLE0508 | ||||
| Study Sponsor ICMJE | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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