Actinic Keratoses
Conditions
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.
Interventions
Imiquimod 3.75% Cream
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| immunomodulatory-induced inflammatory reaction | two weeks | Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks. |
Countries
Austria
Outcome results
None listed