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

Carcinoma, Basal Cell Clinical Trial

— Imiquimod  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00803907
• Other study ID #: 0559/07
• Status: Recruiting
• Phase: Phase 4
• First received: December 3, 2008
• Last updated: June 12, 2012
• Start date: December 2008
• Est. completion date: February 2013

Study information

• Verified date: June 2012
• Source: University of Sao Paulo
• Contact: Erick Macedo
• Phone: 11-3069-7871
• Email: erickmarcet[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• Imiquimod 5% cream
Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-treatment biopsy		post-treatment biopsy	Yes