Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks

NCT ID: NCT02090465

Last Updated: 2019-12-17

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

Total Enrollment

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.

Detailed Description

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Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.

Conditions

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Actinic Keratosis

Keywords

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Actinic Keratosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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all eligible patients

Treatment with Picato according to Summary of Product Characteristics (SmPC)

Ingenol Mebutate

Intervention Type DRUG

No intervention: observation of routine use of Picato®

Interventions

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Ingenol Mebutate

No intervention: observation of routine use of Picato®

Intervention Type DRUG

Other Intervention Names

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Picato®

Eligibility Criteria

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Inclusion Criteria

• Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.

Exclusion Criteria

* Preceding use of Picato® on the area planned for treatment
* Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks
* Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment
* Open wounds on the area planned for treatment
* Contraindications according to prescribing information
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Diepgen, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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Universitätsklinikum Heidelberg/Klinische Sozialmedizin

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DE-Picato NIS-2013

Identifier Type: -

Identifier Source: org_study_id