Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream

Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream - Actinic Keratosis with Imiquimod 3.75% Cream

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003316-27-AT

Enrollment

Registered

2021-02-18

Start date

2021-04-01

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actintic keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: zyclara 3.75% cream sachets Product Name: Zyclara 3.75% cream Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Current Sponsor code: 12020 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactProf. Dr. Daisy Kopera

Medical University of Graz

daisy.kopera@medunigraz.at0043316385 81817

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026