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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

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ClinicalTrials.gov Identifier: NCT02090465
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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
Actinic Keratosis Drug: Ingenol Mebutate

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

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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 : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Picato®




Primary Outcome Measures :
  1. Actinic keratosis [ Time Frame: 8 weeks ]
    Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®

  2. Skindex-16 [ Time Frame: 8 weeks ]
    Patient' s quality of life during ambulant routine use of Picato®

  3. Dosage of Picato® [ Time Frame: 8 weeks ]
    Prescribed and applied dosages and adherence during ambulant routine use of Picato®



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with actinic keratosis contacting their dermatologist
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090465


Locations
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Germany
Universitätsklinikum Heidelberg/Klinische Sozialmedizin
Heidelberg, Germany, D-69115
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Thomas Diepgen, Prof. Dr. med. University Hospital Heidelberg
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02090465    
Other Study ID Numbers: DE-Picato NIS-2013
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Keywords provided by LEO Pharma:
Actinic Keratosis
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms