NCT02090465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

March 12, 2014

Last Update Submit

December 13, 2019

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

all eligible patients

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

Drug: Ingenol Mebutate

Interventions

Ingenol MebutateDRUG

No intervention: observation of routine use of Picato®

Also known as: Picato®
all eligible patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with actinic keratosis contacting their dermatologist

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Heidelberg/Klinische Sozialmedizin

Heidelberg, D-69115, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thomas Diepgen, Prof. Dr. med.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 18, 2014

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations

DE(1)