Carcinoma, Basal Cell
Conditions
Keywords
immunomodulator, Carcinoma, Basal Cell
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.
Interventions
Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| post-treatment biopsy | post-treatment biopsy |
Countries
Brazil
Contacts
Primary ContactErick Macedo
Outcome results
None listed