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Photosensitizer

BF-200 ALA + PDT for Actinic Keratosis

Phase 3
Recruiting
Led By Nathalie Zeitouni, MD
Research Sponsored by Biofrontera Bioscience GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of 4 - 15 mild to moderate clinically confirmed AK lesions according to Olsen on the extremities or on the neck/trunk with a diameter of ≥ 4 mm in the treatment field
For female subjects with reproductive potential: Effective contraception at screening visit and throughout the treatment phase of the study
Must not have
Sunburn or other possible confounding skin conditions inside or in close proximity to the treatment field
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening (up to 4 weeks before treatment) and 12 weeks after the last pdt (visit 4 or visit 6)
Awards & highlights
Pivotal Trial

Summary

This trial tests a new therapy for actinic keratosis using a gel and a light lamp to see if it is safe and effective.

Who is the study for?
This trial is for adults with 4-15 mild to moderate Actinic Keratosis lesions on extremities or neck/trunk. Participants must be in good health, not use tanning beds, and agree to a biopsy if needed. Women of childbearing age must have a negative pregnancy test and use contraception.
What is being tested?
The study tests the safety and effectiveness of BF-200 ALA gel with RhodoLED lamp light therapy versus a placebo treatment for Actinic Keratosis. Patients will receive up to two treatments within about 12 weeks.
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site such as redness, swelling, burning sensation, itching or scaling. There might also be sensitivity to sunlight on treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have 4-15 mild to moderate skin lesions on my arms, legs, neck, or trunk.
Select...
I am using effective birth control and will continue to do so during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have sunburn or skin issues near the area to be treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all visits (except screening, visit 1) throughout entire study duration, approx. 16 weeks for subjects requiring 1 pdt (until visit 4) and approx. 28 weeks for subjects with 2 pdts (until visit 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and all visits (except screening, visit 1) throughout entire study duration, approx. 16 weeks for subjects requiring 1 pdt (until visit 4) and approx. 28 weeks for subjects with 2 pdts (until visit 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall subject complete response rate
Secondary study objectives
Application site pain during illumination
Assessment of application site reactions
Complete response rate for severe lesions
+14 more
Other study objectives
Any SAE and relevant AE
Esthetic appearance at follow-up visits assessed by the investigator
Esthetic outcome at follow-up visits assessed by the subject
+5 more

Side effects data

From 2020 Phase 1 trial • 48 Patients • NCT04319159
100%
Application site erythema
100%
Application site oedema
100%
Application site pain
63%
Application site exfoliation
31%
Application site scab
25%
Application site warmth
25%
Application site paraesthesia
25%
Application site pruritus
13%
Application site hyperaesthesia
13%
Application site induration
6%
Application site vesicles
6%
Application site discharge
6%
Application site discolouration
6%
Application site erosion
6%
Application site fissure
6%
Application site haemorrhage
6%
Seasonal allergy
6%
Application site pustules
6%
Bacteriuria
6%
COVID-19
6%
Pyuria
6%
Headache
6%
Sinus headache
6%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stratum: Face/Scalp
Stratum: Periphery

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BF-200 ALAExperimental Treatment1 Intervention
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). Red light photodynamic therapy (PDT)
Group II: VehiclePlacebo Group1 Intervention
Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BF-200 ALA and red light LED lamp
2020
Completed Phase 1
~160

Find a Location

Who is running the clinical trial?

Biofrontera Bioscience GmbHLead Sponsor
10 Previous Clinical Trials
1,658 Total Patients Enrolled
Nathalie Zeitouni, MDPrincipal InvestigatorMedical Dermatology Specialists; Phoenix, Arizona, United States
3 Previous Clinical Trials
238 Total Patients Enrolled

Media Library

BF-200 ALA (Ameluz®) (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05662202 — Phase 3
Actinic Keratosis Research Study Groups: BF-200 ALA, Vehicle
Actinic Keratosis Clinical Trial 2023: BF-200 ALA (Ameluz®) Highlights & Side Effects. Trial Name: NCT05662202 — Phase 3
BF-200 ALA (Ameluz®) (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662202 — Phase 3
~41 spots leftby Sep 2025
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