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

Phase 4
18 Years
90 Years
Open (Enrolling)
Carcinoma, Basal Cell

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

post-treatment biopsy

Outcome Time Frame:

post-treatment biopsy

Safety Issue:


Principal Investigator

E M macedo

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Sao Paulo


Brazil: Ethics Committee

Study ID:




Start Date:

December 2008

Completion Date:

February 2013

Related Keywords:

  • Carcinoma, Basal Cell
  • immunomodulator
  • Carcinoma, Basal Cell
  • Carcinoma
  • Carcinoma, Basal Cell