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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: arbutin, tretinoin, triamcinolone
  • arbutin, tretinoin, triamcinolone
• Drug: Triluma
  • Hydroquinone, Fluoncinolone, Tretinoin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • arbutin, tretinoin, triamcinolone
• Active Comparator: 2
  • Triluma

Primary Measures

• evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma.
  • Time Frame: arbutin triamcinolone tretinoin
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Overall Clinical Trial Officials and Contacts

Overall Contact: alexandre frederico, doctor 55 19 3829-3822 dr.alexandre@alclinica.com.br

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00717652

Study ID Number: ATTGLE0508

ClinicalTrials.gov Identifier: NCT00717652

Health Authority: Brazil: National Health Surveillance Agency