Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Imiquimod
1 other identifier
interventional
20
1 country
1
Brief Summary
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJune 13, 2012
June 1, 2012
3.8 years
December 3, 2008
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-treatment biopsy
post-treatment biopsy
Study Arms (1)
nodular BCC of the eyelid
EXPERIMENTALPatients with nodular BCC of the eyelid
Interventions
Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
São Paulo, São Paulo, Brazil
Related Publications (1)
de Macedo EM, Carneiro RC, de Lima PP, Silva BG, Matayoshi S. Imiquimod cream efficacy in the treatment of periocular nodular basal cell carcinoma: a non-randomized trial. BMC Ophthalmol. 2015 Apr 3;15:35. doi: 10.1186/s12886-015-0024-0.
PMID: 25885553DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E M macedo
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
Study Record Dates
First Submitted
December 3, 2008
First Posted
December 8, 2008
Study Start
December 1, 2008
Primary Completion
September 1, 2012
Study Completion
February 1, 2013
Last Updated
June 13, 2012
Record last verified: 2012-06