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

Condition(s) targeted: Melasma

Intervention: arbutin, tretinoin, triamcinolone (Drug); Triluma (Drug)

Phase: Phase 2/Phase 3

Status: Suspended

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

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

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).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Lal Clinica Pesquisa E Desenvolvimento Ltda, Valinhos, S 13270000, Brazil

Starting date: July 2008
Last updated: October 22, 2010