A randomized placebo-controlled clinical trial of topical photodynamic therapy with a nanoemulsion formulation of 5-aminolevulinic acid for the treatment of actinic keratosis
- Conditions
- actinic keratosis (AK)Classification code 10000614
- Registration Number
- EUCTR2006-000314-20-DE
- Lead Sponsor
- Biofrontera Bioscience GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
1. Are willing and able to sign informed consent form.
2. Men and women aged between 18 and 85 years.
3. Accept to abstain from sunbathing and the solarium during the study.
4. Have at least 3 clinically confirmed AK target lesions within the face or scalp (excluding eylids, lips and mucosa). The AK lesions must be discrete and quantifiable. The total AK lesion area should not exceed 200 cm2.
5. Are free of any significant physical abnormalities (eg, tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
6. Are willing to stop using moisturizers and any other topical treatments with anti-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and creams, and green tea preparations during the study within the treatment area. Sunscreens will be allowed, but should not be applied in the treatment area within approximately 24 hours of a clinic visit with lesion count.
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
1. Have known hypersensitivity to ALA.
2. Have received any other medication known to affect AK 3 months before or during the study.
3. Are patients under immunosuppression therapy.
4. Suffer from porphyria.
5. Show hypersensitivity to porphyrins.
6. Suffer from photodermatoses.
7. Have inherited or acquired coagulation defects.
8. Receive medication with hypericin or any photosensitizer.
9. Have evidence of clinically significant, unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular (NYHA class III, IV), immunosuppressive, hematologic, hepatic, renal, neurologic, endocrine, collagen-vascular, gastrointestinal disease
10. Have currently other malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).
11./12. Have received treatments as listed for any indication in the treatment area or systemic treatments as listed within the designated time period before PDT treatment with ALA
13. Treatment with ALA.
14. Known allergy against polysorbate 80, capylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, propylene glycol, methyl parahydrobenzoate, or propyl parahydrobenzoate; compare with Section 7.1).
15. Are known to be pregnant or lactating (currently or within the past 3 months).
16. Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment with topical ALA or cause difficulty with examination (e.g. psoriasis, eczema).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1) efficacy of topical photodynamic therapy (PDT) with new nanoemulsion formulation of 5-ALA calculated by the AK clearance rate<br>2) to define the effective therapeutic dose <br> ;Secondary Objective: 1)safety and tolerability of the new nanoemulsion ALA-formulation,<br>2) cosmetic outcome <br>12 weeks after photodynamic therapy;Primary end point(s): total clearance rate of all AK lesions, defined as the number of lesions showing complete remission
- Secondary Outcome Measures
Name Time Method