Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

January 10, 2022 updated by: Medical University of Graz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Universitätsklinik für Dermatologie und Venerologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Earliest Stage Treatment of Aktinic Keratosis
Drug: Imiquimod 3.75% Cream
Imiquimod 3.75% Cream

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2021

Primary Completion (Actual)

August 23, 2021

Study Completion (Actual)

August 23, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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