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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00717652
First received: July 15, 2008
Last updated: October 22, 2010
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Melasma
Drug: arbutin, tretinoin, triamcinolone
Drug: Triluma
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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).

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma. [ Time Frame: arbutin triamcinolone tretinoin ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
arbutin, tretinoin, triamcinolone
Drug: arbutin, tretinoin, triamcinolone
arbutin, tretinoin, triamcinolone
Active Comparator: 2
Triluma
Drug: Triluma
Hydroquinone, Fluoncinolone, Tretinoin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717652

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, S, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00717652     History of Changes
Other Study ID Numbers: ATTGLE0508
Study First Received: July 15, 2008
Last Updated: October 22, 2010
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Tretinoin
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014