A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis

NCT02799030 | Completed Phase 2

• 1 other identifier: ALA-AK-CT001
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK).

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Total clearance rate of AK lesions

  Total clearance rate of all AK lesions, defined as the percentage of baseline lesions within the target treatment areas showing complete remission at week 12 post treatment.

  12 weeks after photodynamic therapy (PDT)

Secondary Outcomes (7)

• Percentage of subjects totally cleared

  12 weeks after PDT

• Reduction of Total Lesion Area

  12 weeks after PDT

• Reduction of Lesion Size

  12 weeks after PDT

• Overall Cosmetic Outcome

  12 weeks after PDT

• Local Skin Reactions

  during anf after PDT [3h - 4 h]

Study Arms (4)

BF-200 ALA 0%

PLACEBO COMPARATOR

Topical application of matched placebo gel without containing 5-ALA. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.

Drug: BF-200 ALA 1%; Drug: BF-200 ALA 3%; Drug: BF-200 ALA 10%

BF-200 ALA 1%

EXPERIMENTAL

Topical application of BF-200 ALA gel containing 0.78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.

Drug: BF-200 ALA 1%

BF-200 ALA 3%

EXPERIMENTAL

Topical application of BF-200 ALA gel containing 3.8 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.

Drug: BF-200 ALA 3%

BF-200 ALA 10%

EXPERIMENTAL

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and approximately 1 cm of the surrounding margin.

Drug: BF-200 ALA 10%

Interventions

BF-200 ALA 1% DRUG

topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .

BF-200 ALA 0%; BF-200 ALA 1%

BF-200 ALA 3% DRUG

topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .

BF-200 ALA 0%; BF-200 ALA 3%

BF-200 ALA 10% DRUG

topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .

Also known as: Ameluz

BF-200 ALA 0%; BF-200 ALA 10%

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects were willing and able to sign the informed consent form.
• Men and women aged between 18 and 85 years.
• Had a general good and stable health condition as confirmed by a physical examination and by medical history.
• The subjects accepted to abstain from sunbathing and the solarium during the study.
• The subjects had at least 3 but not more than 10 clinically confirmed AK target lesion of mild to moderate intensity within the face or bald scalp (excluding eyelids, lips and mucosa), i.e. AK grade I and II. Grade I AK lesions presented as flat, pink maculae without signs of hyperkeratosis and erythema.
• The AK lesions had to be discrete and quantifiable; the distance from one lesion to its neighbour lesion was greater than 1.5 cm.
• The diameter of each AK lesion was not less than 0.5 cm and not greater than 1.5 cm.
• The subjects were free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that could cause difficulty with examination or final evaluation.
• The subjects were 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 was allowed, but was not to be applied in the treatment area within approximately 24 hours of a clinic visit with lesion count.
• Only women of childbearing potential who used a highly effective method of contraception and who had a negative serum pregnancy test were allowed to participate in this study.

You may not qualify if:

• Had a known hypersensitivity to ALA.
• Had received any other medication known to affect AK 3 months before or during the study.
• Were under immunosuppressive therapy.
• Suffered from porphyria.
• Showed hypersensitivity to porphyrins.
• Suffered from photodermatoses.
• Had inherited or acquired coagulation defects.
• Received medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to treatment with study drug and PDT
• Had evidence of clinically significant, unstable medical conditions such as
• a metastatic tumour or a tumour with a high probability of metastatic spread
• cardiovascular (NYHA class III, IV)
• immunosuppressive
• haematological, hepatic, renal, neurological, endocrine
• collagen-vascular
• gastrointestinal.

Sponsors & Collaborators

• Biofrontera Bioscience GmbH: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rolf-Markus Szeimies, Prof Dr

  Klinikum der Universität Regensburg Klinik und Poliklinik für Dermatologie Franz-Josef-Strauß-Allee 11

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 14, 2016
• Study Start: October 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: July 19, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share