Efficacy of Actikerall® in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004969

Enrollment

1650

Registered

2013-05-15

Start date

2013-02-18

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

Actinic keratosis L57.0

Interventions

Group 1: Study population consists of patients, who had recently been adjusted to Actikerall® therapy in routine medical practice due to actinic keratosis (clinical grade I or II according to Olsen).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Enrolled patients are to be immune-competent, adult patients suffering from actinic keratosis (clinical stage I or II according to Olsen), who are to be treated with Actikerall® based upon physicians´ therapeutic decision.

Exclusion criteria

Exclusion criteria: *hypersensitivity to fluorouracil or salicylic acid *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
Description of efficacy of Actikerall® therapy in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration in routine medical 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) and changes in 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

Description of efficacy of Actikerall® therapy in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration in routine medical 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) and changes in 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 end-point to be investigated are duration of therapy under Actikerall® (mean duration of therapy) as well as patients´ satisfaction and handling of Actikerall® determined by means of a standardized questionnaire. The questionnaire is handed out to the patient for completion at baseline examination and will be returned at the respective following examination.	—

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