Melasma Clinical Trial - Efficiency And Safety Of Association Arbutin,

Status Suspended

Clinical Trial Summary

The objective of this study is evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone) in the treatment of epidermal melasma.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00717652
Study type	Interventional
Source	Azidus Brasil
Contact
Status	Suspended
Phase	Phase 2/Phase 3
Start date	July 2008
Completion date	July 2008

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma — melasma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms