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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on follow-up visit 1 (6 months after last pdt) and follow-up visit 2 (12 months after last pdt)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at screening (up to 4 weeks before treatment) and 12 weeks after the last pdt (visit 4 or visit 6)
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall subject complete response rate
Secondary outcome measures
Application site pain during illumination
Assessment of application site reactions
Complete response rate for severe lesions
+14 moreOther outcome measures
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 moreSide effects data
From 2020 Phase 1 trial • 48 Patients • NCT04319159100%
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 discolouration
6%
Application site pustules
6%
Pyuria
6%
Alopecia
6%
COVID-19
6%
Application site haemorrhage
6%
Application site vesicles
6%
Application site discharge
6%
Application site erosion
6%
Seasonal allergy
6%
Bacteriuria
6%
Headache
6%
Application site fissure
6%
Sinus headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stratum: Face/Scalp
Stratum: Periphery
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
~150
Find a Location
Who is running the clinical trial?
Biofrontera Bioscience GmbHLead Sponsor
10 Previous Clinical Trials
1,646 Total Patients Enrolled
Nathalie Zeitouni, MDPrincipal InvestigatorMedical Dermatology Specialists; Phoenix, Arizona, United States
2 Previous Clinical Trials
218 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have 4-15 mild to moderate skin lesions on my arms, legs, neck, or trunk.Women who can have babies need to have a negative pregnancy test.I am willing to stop using skin products in the treatment area 24 hours before my next visit.I am using effective birth control and will continue to do so during the study.I agree not to sunbathe or use tanning beds during treatment.I am in good health or my medical conditions are stable.I am willing to follow the study's requirements and can receive up to 2 treatments within 12 weeks.I do not have any health issues that would make it hard to follow the study or affect my safety.I do not have sunburn or skin conditions near the treatment area.It is suspected that you are using drugs or alcohol excessively.I haven't used certain medications on my skin or taken them by mouth or injection recently.You have had a bad reaction to ALA, porphyrins, or other ingredients in the study medication BF-200 ALA.I have sunburn or skin issues near the area to be treated.I am willing and able to give my consent and sign the HIPAA form.I am willing to have a small skin sample taken for each severe skin lesion.You have had an allergic reaction to soy or peanuts in the past.
Research Study Groups:
This trial has the following groups:- Group 1: BF-200 ALA
- Group 2: Vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings for enrollment in this study?
"According to the clinicaltrials.gov website, this trial has stopped recruiting patients since December 20th 2022. However, 22 other medical studies are currently seeking volunteers for their trials."
Answered by AI
Is BF-200 ALA a secure choice for patients?
"The safety of BF-200 ALA has been assessed as a 3 on our team's scale due to the Phase 3 trial, signalling both an efficacy profile and multiple validations of its security."
Answered by AI
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