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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00717652
Recruitment Status : Suspended
First Posted : July 17, 2008
Last Update Posted : October 25, 2010
Sponsor:
Information provided by:
Azidus Brasil

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2008
Estimated Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma. [ Time Frame: arbutin triamcinolone tretinoin ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717652


Locations
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Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, S, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
More Information
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Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00717652     History of Changes
Other Study ID Numbers: ATTGLE0508
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: July 2008
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Tretinoin
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents