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

NCT ID: NCT00717652

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-07-31

Brief Summary

The objective of this study is 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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

arbutin, tretinoin, triamcinolone

Group Type: EXPERIMENTAL

arbutin, tretinoin, triamcinolone

Intervention Type: DRUG

arbutin, tretinoin, triamcinolone

2

Triluma

Group Type: ACTIVE_COMPARATOR

Triluma

Intervention Type: DRUG

Hydroquinone, Fluoncinolone, Tretinoin

Interventions

arbutin, tretinoin, triamcinolone

arbutin, tretinoin, triamcinolone

Intervention Type: DRUG

Triluma

Hydroquinone, Fluoncinolone, Tretinoin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Azidus Brasil

Principal Investigator Dr. Alexandre Frederico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, S, Brazil

Countries

Brazil

Other Identifiers

ATTGLE0508

Identifier Type: -

Identifier Source: org_study_id