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PDT vs PDT in combination with 3,75% Imiquimod in patients with actinic keratosis

Enhanced efficacy of photodynamic therapy in combination with 3,75% imiquimod - a randomised, prospective , observer-blinded study in patients with actinic keratosis - PDT vs PDT and 3,75% Imiquimod in patients with AK

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004228-12-AT
Enrollment
Unknown
Registered
2014-09-03
Start date
2014-09-26
Completion date
Unknown
Last updated
2014-10-27

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

Conditions

non melanoma skin cancer MedDRA version: 17.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Ameluz Product Name: Ameluz Product Code: EMEA/H/C/002204-N/005 Pharmaceutical Form: Gel INN or Proposed INN: 5-Aminolevulinic acid CAS Number: 106-60-5 Other descriptive name: METHYL AMIN

Sponsors

Medizinische Universität Wien, univ. Klinik f. Dermatologie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with clinically confirmed actinic keratosis in the face and scalp Age 18 years or older 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

Exclusion criteria: Known allergy to imiquimod and aminlevulinic acid Patients with porphyria or taking photosensitizing drugs Patients with severe compromised general state Patients who are participating in another study Patients unable to stick to the study protocol Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the efficacy of photodynamic therapy in combination with 3,75% imioquimod versus photodynamic monotherapy in patients with actinic keratosis;Secondary Objective: To compare the tolerability , relapse rate , patients satisfaction and cosmetic results after treatment with photodynamic monotherapy versus photodynamic therapy in combination with 3,75% imiquimod in the patients with actinic keratosis;Primary end point(s): Percentage of actinic keratosis cleared 3 months after completion of treatment in both groups;Timepoint(s) of evaluation of this end point: Clinical control after 3 and 6 months after treatment with PDT mono or PDT in combination with imiquimod—

Secondary

MeasureTime frame
Secondary end point(s): The recurrence rate of actinic keratosis at 6 months after completion of therapy in both treatmens groups. Cosmetic response and global patients satisfaction ;Timepoint(s) of evaluation of this end point: Recurrence rate 6 months after completion of therapy in both treatment groups Cosmetic response and global patients satisfaction 6 moths after completions of therapy in both treatment groups—

Countries

Austria

Contacts

Public ContactUniv. Klinik für Dermatologie

Medizinische Universität Wien, Univ. Klinik für Dermatologie

sonja.radakovic@meduniwien.ac.at+431404007702

Outcome results

None listed

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