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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005636

Enrollment

1300

Registered

2014-01-14

Start date

2014-01-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L57.0

Interventions

Group 1: Study population consists of patients, who had recently been adjusted to Actikerall® therapy. One optional check-up examination is intended under treatment with Actikerall®. On terminating th

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Germany

Contacts

Public ContactUrsula Burkard

ANFOMED GmbH

ursula.burkard@anfomed.de09133-7762-11

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026