Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Actinic Keratoses

Treatments: Drug: Imiquimod 3.75% Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04842422

12020

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Earliest Stage Treatment of Aktinic Keratosis

Experimental group

Treatment:

Drug: Imiquimod 3.75% Cream