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

NCT ID: NCT00803907

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Carcinoma, Basal Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nodular BCC of the eyelid

Patients with nodular BCC of the eyelid

Group Type EXPERIMENTAL

Imiquimod 5% cream

Intervention Type DRUG

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

Interventions

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Imiquimod 5% cream

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

Intervention Type DRUG

Other Intervention Names

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immunomodulator

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Erick Marcet Santiago de Macedo

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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E M macedo

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Erick Macedo

Role: CONTACT

11-3069-7871

Facility Contacts

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E M Macedo

Role: primary

11-3069-7871

References

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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.

Reference Type DERIVED
PMID: 25885553 (View on PubMed)

Other Identifiers

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0559/07

Identifier Type: -

Identifier Source: org_study_id

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