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NCT02090465 Clinical Trial

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

Actinic Keratosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02090465
Other study ID # DE-Picato NIS-2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date December 2013

Study information
Verified date December 2019
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 840
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Universitätsklinikum Heidelberg/Klinische Sozialmedizin Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Actinic keratosis Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato® 8 weeks
Primary Skindex-16 Patient' s quality of life during ambulant routine use of Picato® 8 weeks
Primary Dosage of Picato® Prescribed and applied dosages and adherence during ambulant routine use of Picato® 8 weeks
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