Aldara for the Treatment of Large and/or Multiple sBCC | NCT00189280

Studies
Aldara for the Treatment of Large and/or Multiple sBCC

NCT00189280

Sponsor

MEDA Pharma GmbH & Co. KG

Status

Completed

Last Update Posted

Feb 22, 2022Actual

Enrollment

111Actual

Phase

Phase 3

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Countries

France

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

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 2005Estimated

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

Feb 4, 2022

Last Update Posted Date

Feb 22, 2022Actual

Description Module

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.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
imiqimod 5% cream	Experimental		Drug: Imiquimod

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod	Drug	cream 5%, 5 days out of seven, for 6 weeks	imiqimod 5% cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical clearance of sBCC		12 or 16 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
Reduction in size of tumour		12 or 16 weeks after treatment
Rate of clearance, Cosmetic outcome		12 or 16 weeks after treatment
Sustained clearance rate over 3 year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Professeur Bedane	Service de DermatologieHôpital Dupuytren, LIMOGES	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de DermatologieHôpital Dupuytren		Limoges		87042	France

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077271	Imiquimod

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided