A randomized, double-blind, phase III multicenter study evaluating the safety and efficacy of BF-200 ALA versus placebo in the treatment of actinic keratosis when using PDT

• Conditions: actinic keratosis (AK); MedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosis

• Registration Number: EUCTR2007-003371-39-DE
• Lead Sponsor: Biofrontera Bioscience GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Are willing and able to sign informed consent form.
2. Men and women aged between 18 and 85 years inclusive.
3. Have a general good and stable health condition as confirmed by a physical examination and by medical history.
4. Patients with clinically stable medical conditions including, but not limited to the following diseases will be allowed to be included into the study, if the medication taken for the treatment of the disease does not match the criteria of the excluded or disallowed medications listed in points 7, 10, 11 and 12 of the exclusion criteria:
• controlled hypertension, • diabetes mellitus type II, • hypercholesterolaemia,
• osteoarthritis
5. Accept to abstain from sunbathing and the solarium during the study.
6. Have at least 4 but not more than 8 clinically confirmed AK target lesions of mild to moderate intensity within the face or bald scalp (excluding eyelids, lips and mucosa), i. e. actinic keratoses grade I and II according to Olsen et. al. 1991
7. The AK lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion is greater than 1.0 cm
8. The diameter of each AK lesion is to be not less than 0.5 cm and not greater than 1.5 cm.
9. Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
10. 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 before a clinical visit with lesion count.
11. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception and had a negative serum pregnancy test. A female is considered to be of childbearing potential if she possesses an uterus and at least one ovary, has not had a tubal ligation, or she is not at least 3 years postmenopausal. Highly effective methods of birth control are defined as resulting in a low failure rate (Pearl Index below 1, failure rate less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. The use of condoms without spermicide coating is not considered to be a highly effective method of contraception.

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

1. Have known hypersensitivity to ALA.
2. Are patients under immunosuppressive therapy.
3. Suffer from porphyria.
4. Show hypersensitivity to porphyrins.
5. Suffer from photodermatoses.
6. Have inherited or acquired coagulation defects.
7. Have received medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential such as psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolons, fibrates, or phytotherapy with St. John’s wort, arnica, or valerian or topically applied phototoxic substances like tar, pitch, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal rose, acridine within 8 weeks prior to treatment with study drug and PDT.
8. 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
9. Have currently other malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, invasive squamous cell carcinoma).
10. Any topical treatment within the treatment area within 12 weeks before PDT treatment with BF-200 ALA; biopsy taken at the screening visit is allowed.
11. Topical treatment with ALA or MAL (methyl-aminolevulinic acid) outside the treatment area during participation in the study.
12. None of the following systemic treatments within the designated period before PDT treatment with BF-200 ALA and during participation in the study:
interferon (6 weeks), immunomodulators or immunosuppressive therapies (10 weeks), cytotoxic drugs (6 months), investigational drugs (8 weeks), drugs known to have major organ toxicity (8 weeks), corticosteroids (6 weeks), inhaled corticosteroids (4 weeks), methyl-aminolevulinic acid or ALA (12 weeks)
13. Known allergy against polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, propylene glycole; sodium benzoate
14. Are known to be pregnant or lactating (currently or within the past 3 months).
15. 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).
16. Show cornu cutaneum like alterations of the skin in the face or on the bald scalp (target area).
17. Are currently or within the past 8 weeks participating in another clinical study.
18. Have active chemical dependency or alcoholism as assessed by the investigator.
19. Confirmed diagnosis of HIV

Study & Design

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