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

Primary Purpose

Carcinoma, Basal Cell

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Imiquimod 5% cream
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Basal Cell focused on measuring immunomodulator, Carcinoma, Basal Cell

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nodular BCC of the eyelid

Arm Description

Patients with nodular BCC of the eyelid

Outcomes

Primary Outcome Measures

post-treatment biopsy

Secondary Outcome Measures

Full Information

First Posted
December 3, 2008
Last Updated
June 12, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00803907
Brief Title
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Acronym
Imiquimod
Official Title
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell
Keywords
immunomodulator, Carcinoma, Basal Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nodular BCC of the eyelid
Arm Type
Experimental
Arm Description
Patients with nodular BCC of the eyelid
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5% cream
Other Intervention Name(s)
immunomodulator
Intervention Description
Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)
Primary Outcome Measure Information:
Title
post-treatment biopsy
Time Frame
post-treatment biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erick Macedo
Phone
11-3069-7871
Email
erickmarcet@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E M macedo
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E M Macedo
Phone
11-3069-7871
Email
erickmarcet@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
E M Macedo

12. IPD Sharing Statement

Citations:
PubMed Identifier
25885553
Citation
de Macedo EM, Carneiro RC, de Lima PP, Silva BG, Matayoshi S. Imiquimod cream efficacy in the treatment of periocular nodular basal cell carcinoma: a non-randomized trial. BMC Ophthalmol. 2015 Apr 3;15:35. doi: 10.1186/s12886-015-0024-0.
Results Reference
derived

Learn more about this trial

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

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