Evaluation of Two Different Non-invasive Techniques to Mo... | NCT00294320

Studies
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions

NCT00294320

Sponsor

MEDA Pharma GmbH & Co. KG

Status

Completed

Last Update Posted

Feb 7, 2022Actual

Enrollment

12Actual

Phase

Phase 3

Conditions

Actinic Keratosis

Interventions

Aldara (Imiquimod)
Vehicle cream

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

Feb 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

Feb 21, 2006

First Submission Date that Met QC Criteria

Feb 21, 2006

First Posted Date

Feb 22, 2006Estimated

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 7, 2022Actual

Description Module

Brief Summary

The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.

Detailed Description

Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	250mg of Imiquimod cream application once daily 3 times per week.	Drug: Aldara (Imiquimod)
2	Placebo Comparator	250mg vehicle cream for application once daily 3 times per week.	Other: Vehicle cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aldara (Imiquimod)	Drug	250mg of Imiquimod cream for application once daily 3 times per week.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.		8 weeks after the end of treatment

Secondary Outcomes

Measure	Description	Time Frame
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.		8 weeks after the end of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
Free of any significant findings (e.g tattoos) in the potential application site area.
Willing to discontinue sun-tanning and use of sunbed/sun parlour use
Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment

Exclusion Criteria:

Evidence of unstable or uncontrolled clinically significant medical condition.
Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
Have active chemical dependency or alcoholism
Have know allergies to any excipient or study cream
Have received previous treatment with imiquimod for any indication within the treatment area.
Known to be affected by porphyria

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

Name	Affiliation	Role
Jean-Paul Ortonne, Professor	CPCAD, Hopital L'Archet 2	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hopital L'Archet 2		Nice	Cedex 3		France

ID	Term
D055623	Keratosis, Actinic

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases

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