Imiquimod 5% Cream for the Treatment of Periocular Basal... | NCT00803907

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

NCT00803907

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Jun 13, 2012Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod 5% cream

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Sep 2012Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

Dec 3, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erick Marcet Santiago de Macedo, Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nodular BCC of the eyelid	Experimental	Patients with nodular BCC of the eyelid	Drug: Imiquimod 5% cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod 5% cream	Drug	Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)	nodular BCC of the eyelid

Measure	Description	Time Frame
post-treatment biopsy		post-treatment biopsy

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erick Macedo	Contact	11-3069-7871		erickmarcet@yahoo.com.br

Overall Officials

Name	Affiliation	Role
E M macedo	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sao Paulo	Recruiting	São Paulo	São Paulo		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25885553	Derived	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.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D000077271	Imiquimod
D007155	Immunologic Factors

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring