Earliest Stage Treatment of Aktinic Keratosis With Imiqui... | NCT04842422

Studies
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

NCT04842422

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

48Actual

Phase

Phase 4

Conditions

Actinic Keratoses

Interventions

Imiquimod 3.75% Cream

Countries

Austria

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

Jan 2022

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

Apr 16, 2021Actual

Primary Completion Date

Aug 23, 2021Actual

Completion Date

Aug 23, 2021Actual

First Submitted Date

Apr 8, 2021

First Submission Date that Met QC Criteria

Apr 8, 2021

First Posted Date

Apr 13, 2021Actual

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

Jan 10, 2022

Last Update Posted Date

Jan 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream:

The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Earliest Stage Treatment of Aktinic Keratosis	Experimental		Drug: Imiquimod 3.75% Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod 3.75% Cream	Drug	Imiquimod 3.75% Cream	Earliest Stage Treatment of Aktinic Keratosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
immunomodulatory-induced inflammatory reaction	Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.	two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion

Male and female supposed-healthy volunteer outpatients, age: > 50 years.
Diagnosis: patients with chronically UV-exposed photodamaged facial skin.
Consent by signing the ICF (Informed Consent Form)

Exclusion

Current participation in another clinical trial
Patients who are using topical glucocorticoids on the face.
Known intolerance/hypersensitivity to imiquimod
Pregnant/breastfeeding women
Systemic disease, immunodeficiency

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinik für Dermatologie und Venerologie		Graz		8010	Austria

Condition Browse Module

MeSH Terms

ID	Term
D055623	Keratosis, Actinic

Ancestor Terms

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

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