NCT04842422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

April 8, 2021

Last Update Submit

January 10, 2022

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

  • immunomodulatory-induced inflammatory reaction

    Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.

    two weeks

Study Arms (1)

Earliest Stage Treatment of Aktinic Keratosis

EXPERIMENTAL
Drug: Imiquimod 3.75% Cream

Interventions

Imiquimod 3.75% CreamDRUG

Imiquimod 3.75% Cream

Earliest Stage Treatment of Aktinic Keratosis

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für Dermatologie und Venerologie

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 13, 2021

Study Start

April 16, 2021

Primary Completion

August 23, 2021

Study Completion

August 23, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

AU(1)