CompletedPhase 1

Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp

United States112 participantsStarted 2021-12-01

Plain-language summary

The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
✓. Subjects with mild to severe clinically confirmed AK lesions (according to Olsen) on the face and/or scalp. In case of severe AK lesions, a biopsy must be taken for confirmation of diagnosis. At least 8 mild to moderate AK lesions with a diameter of ≥4 mm must be present in the treatment field. The treatment field (continuous or in several patches) totaling about 60 cm2 must be located within one effective illumination area. The AK lesions should be clearly distinguishable, without restrictions on the distance between lesions. Lesions should have a minimal distance of 1 cm between the lesion margin and the border of the treatment field.
✓. All sexes, ≥18 years of age.
✓. Willingness and ability to comply with study procedures, particularly willingness to receive a PDT session and to undergo 2 mm punch biopsy/biopsies in case of severe AK lesion(s) at the screening visit.
✓. Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study. Subjects with clinically stable medical conditions will be permitted for inclusion into the study if not using prohibited medication.
✓. Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the visits.
✓. Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the study.
✓. For female subjects with reproductive potential: Negative serum pregnancy test.

Exclusion criteria

What they're measuring

Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs).

Timeframe: Through study completion, on average 6 weeks

Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe).

Timeframe: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field

Timeframe: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm

Timeframe: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

Application Site Skin Reactions During and Post PDT, Assessed by the Investigator

Timeframe: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

Application Site Discomfort During and Post PDT, Reported by the Subjects

Timeframe: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)

Trial details

NCT IDNCT05060237

SponsorBiofrontera Bioscience GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-20

Results submitted2023-10-31

View on ClinicalTrials.gov More Actinic Keratosis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
✓. Subjects with mild to severe clinically confirmed AK lesions (according to Olsen) on the face and/or scalp. In case of severe AK lesions, a biopsy must be taken for confirmation of diagnosis. At least 8 mild to moderate AK lesions with a diameter of ≥4 mm must be present in the treatment field. The treatment field (continuous or in several patches) totaling about 60 cm2 must be located within one effective illumination area. The AK lesions should be clearly distinguishable, without restrictions on the distance between lesions. Lesions should have a minimal distance of 1 cm between the lesion margin and the border of the treatment field.
✓. All sexes, ≥18 years of age.
✓. Willingness and ability to comply with study procedures, particularly willingness to receive a PDT session and to undergo 2 mm punch biopsy/biopsies in case of severe AK lesion(s) at the screening visit.
✓. Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study. Subjects with clinically stable medical conditions will be permitted for inclusion into the study if not using prohibited medication.
✓. Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the visits.
✓. Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the study.
✓. For female subjects with reproductive potential: Negative serum pregnancy test.