Aldara for the Treatment of Large and/or Multiple sBCC

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-10-31

Brief Summary

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BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.

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Detailed Description

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Conditions

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Carcinoma, Basal Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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imiqimod 5% cream

Group Type EXPERIMENTAL

Imiquimod

Intervention Type DRUG

cream 5%, 5 days out of seven, for 6 weeks

Interventions

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Imiquimod

cream 5%, 5 days out of seven, for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* One or more sBCC on torso, neck or face
* Total surface area \<= 40 sq cm

Exclusion Criteria

* Pregnancy or women who are breastfeeding
* Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors
* Metatypical, adnexal, or sclerodermiform carcinomas
* Current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion
* Known HIV positive serology
* Skin tumor that is already or highly likely to become metastatic
* Presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous)
* Previous organ transplant history

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No