Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Universitätsklinik für Dermatologie und Venerologie

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imiquimod 3.75% Cream

Drug

Imiquimod 3.75% Cream

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Apr 13, 2021
Registry last updated: Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed