Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

NCT ID: NCT04842422

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2021-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Actinic Keratoses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Earliest Stage Treatment of Aktinic Keratosis

Group Type EXPERIMENTAL

Imiquimod 3.75% Cream

Intervention Type DRUG

Imiquimod 3.75% Cream

Interventions

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Imiquimod 3.75% Cream

Imiquimod 3.75% Cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinik für Dermatologie und Venerologie

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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12020

Identifier Type: -

Identifier Source: org_study_id

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