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

Sponsor

Azidus Brasil (Industry)

Overall Status

Suspended

CT.gov ID

NCT00717652

Collaborator

(none)

110

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The objective of this study is evaluating the clinical activity of the association (tretinoin

arbutin + triamcinolone) in the treatment of epidermal melasma.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: arbutin, tretinoin, triamcinolone Drug: Triluma	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 arbutin, tretinoin, triamcinolone	Drug: arbutin, tretinoin, triamcinolone arbutin, tretinoin, triamcinolone
Active Comparator: 2 Triluma	Drug: Triluma Hydroquinone, Fluoncinolone, Tretinoin

Arm

Intervention/Treatment

Experimental: 1

arbutin, tretinoin, triamcinolone

Drug: arbutin, tretinoin, triamcinolone

arbutin, tretinoin, triamcinolone

Active Comparator: 2

Triluma

Drug: Triluma

Hydroquinone, Fluoncinolone, Tretinoin

Outcome Measures

Primary Outcome Measures

evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma. [arbutin triamcinolone tretinoin]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	S	Brazil	13270000

Sponsors and Collaborators

Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00717652

Other Study ID Numbers:

ATTGLE0508

First Posted:

Jul 17, 2008

Last Update Posted:

Oct 25, 2010

Last Verified:

Jul 1, 2008

Additional relevant MeSH terms:

Melanosis

Triamcinolone

Tretinoin

Study Results

No Results Posted as of Oct 25, 2010