on-interventional study investigating Actikerall® II in patients with actinic keratosis (clinical grade I or II according to Olsen) on hands and/or underarms

• Conditions: L57.0; Actinic keratosis

• Registration Number: DRKS00005636
• Lead Sponsor: Almirall Hermal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Study Completion: 2015-03-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

Enrolled patients are to be patients suffering from actinic keratosis (clinical stage I or II according to Olsen) on hands and/or underarms, who are to be treated with Actikerall® based upon physicians´ therapeutic decision.

Exclusion Criteria

•hypersensitivity to fluorouracil/ salicylic acid or any other component of Actikerall®
•planned or existing pregnancy or nursing period
•renal insufficiency
•(pre-)medication containing brivudine, sorivudine or analogs, that has been terminated less than four weeks prior to therapy start with Actikerall®
•Immune suppression

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary goal of the non-interventional study is to survey general efficacy of Actikerall® measured by a reduction of lesions in patients suffering from actinic keratosis (clinical stage I or II according to Olsen) on hands and/or underarms in routine dermatological treatment. Matter of particular interest are clinical changes in lesions under therapy with Actikerall® and beyond end of therapy. Measured values are current findings (total number, mean size (in mm), changes in lesions and treatment of lesions determined by clinical examination and physician´s assessment of Actikerall® (efficacy, tolerance and patient compliance) by means of scales. Values are measured at baseline examination, optional interim examination, final examination (at end of therapy) and final assessment (about eight weeks after final examination). Collected data is documented in a standardized CRF-form.

Secondary Outcome Measures

Name	Time	Method
Additional aspects that are to be investigated in the course of the study are, reduction and development of lesions during Acikerall® therapy, further development of lesions after therapy with Actikerall®, treatment duration and patients´compliance to Actikerall® treatment when applying to hands and/or underarms<br>