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

NCT ID: NCT01966120

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Detailed 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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BF-200 ALA gel

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

Group Type: ACTIVE_COMPARATOR

BF-200 ALA gel

Intervention Type: DRUG

BF-200 ALA was applied over 1-2 fields of approximately 20 cm² in total, allowed to dry for approximately 10 minutes, and covered with occlusive tape material for 3 h.

Photodynamic therapy with BF-RhodoLED

Intervention Type: PROCEDURE

After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.

Placebo to BF-200 ALA gel

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.

Group Type: PLACEBO_COMPARATOR

Placebo to BF-200 ALA gel

Intervention Type: DRUG

The reference product was a placebo (a nanoemulsion gel formulation similar to the Investigational Medicinal Product (IMP), but without the active ingredient). The placebo was packaged, assigned to each patient, and administered in the same way as the IMP.

Photodynamic therapy with BF-RhodoLED

Intervention Type: PROCEDURE

After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.

Interventions

BF-200 ALA gel

BF-200 ALA was applied over 1-2 fields of approximately 20 cm² in total, allowed to dry for approximately 10 minutes, and covered with occlusive tape material for 3 h.

Intervention Type: DRUG

Placebo to BF-200 ALA gel

The reference product was a placebo (a nanoemulsion gel formulation similar to the Investigational Medicinal Product (IMP), but without the active ingredient). The placebo was packaged, assigned to each patient, and administered in the same way as the IMP.

Intervention Type: DRUG

Photodynamic therapy with BF-RhodoLED

After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.

Intervention Type: PROCEDURE

Other Intervention Names

Ameluz; PDT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biofrontera Bioscience GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Reinhold, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dermatologisches Zentrum Bonn

Locations

Dermatologisches Zentrum Bonn Friedensplatz

Bonn, , Germany

Countries

Germany

References

Reinhold U, Philipp-Dormston WG, Dirschka T, Ostendorf R, Aschoff R, Berking C, Jager A, Schmitz B, Foguet M, Szeimies RM. Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED(R) lamp. J Eur Acad Dermatol Venereol. 2025 Aug;39(8):1449-1459. doi: 10.1111/jdv.20452. Epub 2024 Dec 12.

Reference Type: DERIVED

PMID: 39666443 (View on PubMed)

Other Identifiers

2013-002510-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALA-AK-CT007

Identifier Type: -

Identifier Source: org_study_id