Aldara for the Treatment of Large and/or Multiple sBCC

• Sponsor: MEDA Pharma GmbH & Co. KG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00189280
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arm: 1
• Duration (Months): 53
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Basal Cell	Drug: Imiquimod	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: imiqimod 5% cream	Drug: Imiquimod; cream 5%, 5 days out of seven, for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Clinical clearance of sBCC [12 or 16 weeks after treatment]

Secondary Outcome Measures

1. Reduction in size of tumour [12 or 16 weeks after treatment]

2. Rate of clearance, Cosmetic outcome [12 or 16 weeks after treatment]

3. Sustained clearance rate over 3 year follow-up [3 years after treatment]

4. Tolerability & QoL [12 or 16 weeks after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de DermatologieHôpital Dupuytren	Limoges		France	87042

Sponsors and Collaborators

• MEDA Pharma GmbH & Co. KG

Investigators

• Principal Investigator: Professeur Bedane, Service de DermatologieHôpital Dupuytren, LIMOGES

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00189280
• Other Study ID Numbers: 1475-IMIQ
• First Posted: Sep 19, 2005
• Last Update Posted: Feb 22, 2022
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Aldara, sBCC
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Basal Cell; Imiquimod

Study Results

No Results Posted as of Feb 22, 2022