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Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Imiquimod 3.75% Cream
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universitätsklinik für Dermatologie und Venerologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Earliest Stage Treatment of Aktinic Keratosis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2021
Last Updated
January 10, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04842422
Brief Title
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
Official Title
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
August 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Earliest Stage Treatment of Aktinic Keratosis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imiquimod 3.75% Cream
Intervention Description
Imiquimod 3.75% Cream
Primary Outcome Measure Information:
Title
immunomodulatory-induced inflammatory reaction
Description
Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.
Time Frame
two weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universitätsklinik für Dermatologie und Venerologie
City
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

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Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

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