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

Sponsor
LEO Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02090465
Collaborator
(none)
840
Enrollment
1
Location
5
Actual Duration (Months)
167.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ingenol Mebutate

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
840 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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.
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
all eligible patients

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

Drug: Ingenol Mebutate
No intervention: observation of routine use of Picato®
Other Names:
  • Picato®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Actinic keratosis [8 weeks]

      Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®

    2. Skindex-16 [8 weeks]

      Patient' s quality of life during ambulant routine use of Picato®

    3. Dosage of Picato® [8 weeks]

      Prescribed and applied dosages and adherence during ambulant routine use of Picato®

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Heidelberg/Klinische Sozialmedizin Heidelberg Germany D-69115

    Sponsors and Collaborators

    • LEO Pharma

    Investigators

    • Principal Investigator: Thomas Diepgen, Prof. Dr. med., University Hospital Heidelberg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LEO Pharma
    ClinicalTrials.gov Identifier:
    NCT02090465
    Other Study ID Numbers:
    • DE-Picato NIS-2013
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Dec 17, 2019
    Last Verified:
    Dec 1, 2019
    Keywords provided by LEO Pharma
    Actinic Keratosis
    Additional relevant MeSH terms:
    Keratosis, Actinic
    Keratosis

    Study Results

    No Results Posted as of Dec 17, 2019