Quality of life of patients with actinic keratoses and/or a superficial basal cell carcinoma treated with Imiquimod 5% cream.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002501-39-NL

Enrollment

500

Registered

2008-10-30

Start date

2009-02-06

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

patients with actinic keratoses and/or a superficial basal cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10042503 Term: Superficial basal cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10000614 Term: Actinic keratosis

Interventions

Trade Name: Imiquimod or Aldara 5% cream Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient with actinic keratoses and/or a superficial basal cell carcinoma patient has to be able to treat him/herself with the cream, or has someone who can do that for them. patient has to be older than 18 years a signed informed consent by the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patients who are mentally or physically not capable to fill out the questionnaires and the diary patients who are not able to speak Dutch in a way they need to fill out the questionnaires and diary.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate how patients experience self treatment with Imiquimod 5% cream for actinic keratoses and/or a superficial basal cell carcinoma. This is evalueted by several patient reported outcomes: mainly quality of life and treatment satisfaction, however we also evaluate side effects of the treatment with Imiquimod and therapy adherence, because these could influence quality of life and treatment satisfaction.;Secondary Objective: ;Primary end point(s):	—

Measure

Time frame

Main Objective: To evaluate how patients experience self treatment with Imiquimod 5% cream for actinic keratoses and/or a superficial basal cell carcinoma. This is evalueted by several patient reported outcomes: mainly quality of life and treatment satisfaction, however we also evaluate side effects of the treatment with Imiquimod and therapy adherence, because these could influence quality of life and treatment satisfaction.;Secondary Objective: ;Primary end point(s):

—

Countries

Netherlands

Outcome results

None listed

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