Assessment of Treatment Success and Quality of Life in Pa... | NCT02090465

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

NCT02090465

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Dec 17, 2019Actual

Enrollment

840Actual

Phase

Not provided

Conditions

Actinic Keratosis

Interventions

Ingenol Mebutate

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013Actual

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 12, 2014

First Submission Date that Met QC Criteria

Mar 17, 2014

First Posted Date

Mar 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2019

Last Update Posted Date

Dec 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

840Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all eligible patients		Treatment with Picato according to Summary of Product Characteristics (SmPC)	Drug: Ingenol Mebutate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ingenol Mebutate	Drug	No intervention: observation of routine use of Picato®	all eligible patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with actinic keratosis contacting their dermatologist

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Diepgen, Prof. Dr. med.	University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Heidelberg/Klinische Sozialmedizin		Heidelberg		D-69115	Germany

Condition Browse Module

MeSH Terms

ID	Term
D055623	Keratosis, Actinic

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D007642	Keratosis
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C486592	3-ingenyl angelate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided