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

Phase 4

• Conditions: Carcinoma, Basal Cell
• Interventions: Drug: Imiquimod 5% cream

• Registration Number: NCT00803907
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13
• Primary Completion: 2012-09
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nodular BCC of the eyelid	Imiquimod 5% cream	Patients with nodular BCC of the eyelid

Primary Outcome Measures

Name	Time	Method
post-treatment biopsy	post-treatment biopsy

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil