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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Carcinoma, Basal Cell

Treatments: Drug: Imiquimod 5% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT00803907

0559/07

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

nodular BCC of the eyelid

Experimental group

Description:

Patients with nodular BCC of the eyelid

Treatment:

Drug: Imiquimod 5% cream