Aldara for the Treatment of Large and/or Multiple sBCC

MEDA Pharma GmbH & Co. KG111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Carcinoma, Basal Cell

Interventions

ImiquimodDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de DermatologieHôpital Dupuytren

Limoges, France

Outcomes

Primary Outcomes

Clinical clearance of sBCC

Time frame: 12 or 16 weeks after treatment

Secondary Outcomes

Reduction in size of tumour

Time frame: 12 or 16 weeks after treatment

Rate of clearance, Cosmetic outcome

Time frame: 12 or 16 weeks after treatment

Sustained clearance rate over 3 year follow-up

Time frame: 3 years after treatment

Tolerability & QoL

Time frame: 12 or 16 weeks after treatment

Data from ClinicalTrials.gov

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