Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)

Biofrontera

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Drug: Placebo to BF-200 ALA gel; Drug: BF-200 ALA gel; Procedure: Photodynamic therapy with BF-RhodoLED

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966120

2013-002510-12 (EudraCT Number)

ALA-AK-CT007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

Full description

The study was performed as a randomized, multicentre, double-blind, placebo- controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were screened in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED.

Enrollment: 87 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females between 18 and 85 years of age (inclusive)
• Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within 1-2 fields

Exclusion criteria

• History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA
• Current treatment with immunosuppressive therapy
• Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)) within the last 4 weeks
• Confirmed diagnosis of SCC for the representative lesion by screening biopsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 2 patient groups, including a placebo group

BF-200 ALA gel

Active Comparator group

Description:

Photodynamic therapy with BF-RhodoLED in combination with BF-200 ALA.

Treatment:

Procedure: Photodynamic therapy with BF-RhodoLED

Drug: BF-200 ALA gel

Placebo to BF-200 ALA gel

Placebo Comparator group

Description:

Photodynamic therapy with BF-RhodoLED in combination with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.

Treatment:

Procedure: Photodynamic therapy with BF-RhodoLED

Drug: Placebo to BF-200 ALA gel