Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream
Phase 1
- Conditions
- Actintic keratosisMedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-003316-27-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Male and female healthy volunteer outpatients, age: > 50 years.
- Diagnosis: patients* with chronically uv-exposed photodamaged facial skin.
- Consent by signing the ICF
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary endpoint of the study is to demonstrate that AK are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation also already subclinical AK can proliferate into the dermis, it is possible that on chron. light-exposed skin with the application of Imiquimod undetected PE-Ca s can be recognized and treated at the same time).;Secondary Objective: Quantification of subclinical damage present due to UV exposure by graduating the severity of the immunomodulatory-induced inflammatory response.;Primary end point(s): Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.;Timepoint(s) of evaluation of this end point: 2 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Quantity of immunomodulatory-induced inflammatory response assessed according to 4-level scale (none, discrete, moderate, strong).;Timepoint(s) of evaluation of this end point: 4 weeks