Prospective, randomized study of the efficacy of photodynamic therapy in actinic keratosis - PDT in AK

Phase 1

• Conditions: We treat patients with superficial actinic keratosis grade I-II on the face or scalp.

• Registration Number: EUCTR2008-000459-88-DE
• Lead Sponsor: niv.-Prof. Dr. Hans F. Merk, Dept. of Dermatology, University Hospital, RWTH Aachen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-14
• Study Completion: 2010-03-16
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients who comply with the following criteria will be selected for the study:
- Willing and able to sign informed consent form.
- Men aged between 45 to 85 years.
- Postmenopausal women (at least 3 years postmenopausal, 45 to 85 years)
- Histologically or clinically confirmed diagnosis of actinic keratosis grade I (mild actinic keratosis: better palpable [skin roughness], than visible) and grade II (moderate actinic keratosis: palpable [roughness] and visible [red macula or papule with mild keratosis]) of the face and scalp. A histopathologic assessment will be performed in case of doubt to exclude basal cell carcinoma, squamous cell carcinoma, actinic porokeratosis or lentigo-maligna.
- Have a good and stable health condition on the basis of the entrance examination and patient history.
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

Patients may not participate if they meet any of the following criteria:
- Women and men under the age of 45 years.
- Premenopausal, pregnant or breastfeeding women (currently or within the past 3 months)
- History of or clinically proven photodermatoses, porphyria, hypersensitivity to porphyrins or generally known photosensitivity.
- Use of topical medications such as topical steroids, retinoids, imiquimod or 5-fluorouracil within 3 months before the start of the study.
- Immunosuppressive medication (corticosteroids, methotrexate, cyclosporine, azathioprine, chemotherapy, immunotherapy ect.) within 3 months before the start of the study.
- Laser resurfacing or chemical peelings of the areas to be treated within 2 months before inclusion in the study.
-Treatment with photosenzitising drugs like psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolons, fibrates, phytotherapy with St. John`s wart, arnica, valerian or topically applied phototoxic substances like tar, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal red, or acridine.
- Known allergies, hypersensitivity reactions or intolerance to the drug and the ingredients of the 10% BF-200 ALA-gel: soy lecithine, polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, propylene glycole, sodium benzoate.
- Simultaneous participation in other studies.
- Other causes, which lead occording to the investigator to an exclusion from the study.
- Servere systemic disease (egg. cardiovascular (NYHA class III, IV), hematologic, hepatic, renal, endocrine, metastatic tumour disease)
- Lately diagnosed premalignant or malignant skin disease in the treatment area (hypertrophic, hyperkeratotic actinic keratosis grade III, Cornu cutaneum-like lesions, malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
- Severe local reaction (massive erythema with pronounced edema, erosions and pustular reaction), a second PDT will not be performed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our preliminary experience with the Hydrosun-radiator (halogen lamp) indicates that photodynamic therapy (PDT) with visible light (VIS) and water-filtered infrared A (wIRA) compared to conventional light sources such as Aktilite 128 (light-emitting diode, LED) is significantly less painful. We therefore want to investigate on the one hand the influence of wIRA on pain sensations during PDT and to document the treatment success. On the other hand, we want to investigate the influence of wIRA on the penetration depth and thereby on therapeutic outcome.<br>The questions are therefore: <br>I. Is there less pain during VIS/wIRA-PDT compared to VIS-PDT? <br>II Is the therapeutic effect of the VIS/wIRA-PDT worse, comparable to or better than those of the VIS-PDT? <br>III. Can the therapeutic efficacy of PDT be improved by promoting the penetration of the photosensitizer?<br>;Secondary Objective: ;Primary end point(s): After six months the final examination of each patient is performed.