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Trial record 4 of 52 for:    Open Studies | "Carcinoma, Basal Cell"
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Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma

This study is currently recruiting participants.
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Erick Marcet Santiago de Macedo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00803907
First received: December 3, 2008
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.


Condition Intervention Phase
Carcinoma, Basal Cell
 Drug: Imiquimod 5% cream
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma

Resource links provided by NLM:

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

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • post-treatment biopsy [ Time Frame: post-treatment biopsy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 3, 2008
Last Updated: June 12, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
immunomodulator
Carcinoma, Basal Cell

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

ClinicalTrials.gov processed this record on May 19, 2013