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Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma (Imiquimod)

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: NCT00803907
Recruitment Status : Unknown
Verified June 2012 by Erick Marcet Santiago de Macedo, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 8, 2008
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Drug: Imiquimod 5% cream Phase 4

Detailed Description:
This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Study Start Date : December 2008
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: nodular BCC of the eyelid
Patients with nodular BCC of the eyelid
Drug: Imiquimod 5% cream
Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)
Other Name: immunomodulator


Outcome Measures

Primary Outcome Measures :
  1. post-treatment biopsy [ Time Frame: post-treatment biopsy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients whose injuries were confirmed by anatomical and pathological study (periocular superficial basal cell carcinoma).
  • Patients with clinical counter indication for reconstructive surgery (high surgical risk).
  • Patients who have refused a restorative surgery. (aesthetic reasons)
  • Patients who have signed the free and informed consent.

Exclusion Criteria:

  • Patients who have a hypersensitivity reaction to the formula components.
  • Children under 12 years of age.
  • Pregnant and breastfeeding women.
  • Patients whose injury was not confirmed by anatomical and pathological study.
  • Individuals with previous autoimmune or inflammatory disease.
  • Patients who have refused to sign the free and informed term of consent.
Contacts and Locations

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): NCT00803907


Contacts
Contact: Erick Macedo 11-3069-7871 erickmarcet@yahoo.com.br

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: E M Macedo    11-3069-7871    erickmarcet@yahoo.com.br   
Principal Investigator: E M Macedo         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: E M macedo University of Sao Paulo
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erick Marcet Santiago de Macedo, Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00803907     History of Changes
Other Study ID Numbers: 0559/07
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Erick Marcet Santiago de Macedo, University of Sao Paulo:
immunomodulator
Carcinoma, Basal Cell

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers