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

June 12, 2012 updated by: Erick Marcet Santiago de Macedo, University of Sao Paulo
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • University of Sao Paulo
        • Contact:
        • Principal Investigator:
          • E M Macedo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • immunomodulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post-treatment biopsy
Time Frame: post-treatment biopsy
post-treatment biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: E M macedo, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (ESTIMATE)

December 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0559/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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