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Completed

NCT Number: NCT02090465

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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Heidelberg/Klinische Sozialmedizin

Heidelberg, D-69115, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ingenol Mebutate

Drug

No intervention: observation of routine use of Picato®

Other names: Picato®

Primary outcomes

  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®

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2014
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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