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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

Tracking Information
First Submitted Date  ICMJE July 15, 2008
First Posted Date  ICMJE July 17, 2008
Last Update Posted Date October 25, 2010
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
evaluating the clinical activity of the association (tretinoin + arbutin + triamcinolone)in the treatment of epidermal melasma. [ Time Frame: arbutin triamcinolone tretinoin ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00717652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of Melasma
Official Title  ICMJE 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Melasma
Intervention  ICMJE
  • Drug: arbutin, tretinoin, triamcinolone
    arbutin, tretinoin, triamcinolone
  • Drug: Triluma
    Hydroquinone, Fluoncinolone, Tretinoin
Study Arms  ICMJE
  • Experimental: 1
    arbutin, tretinoin, triamcinolone
    Intervention: Drug: arbutin, tretinoin, triamcinolone
  • Active Comparator: 2
    Triluma
    Intervention: Drug: Triluma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: July 16, 2008)
110
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00717652
Other Study ID Numbers  ICMJE ATTGLE0508
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexandre Frederico, LAL Clinica
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azidus Brasil
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP