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Photosensitizer
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
Phase 1
Waitlist Available
Led By Todd Schlesinger, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all visits through study completion after visit 1: visit 2, baseline, treatment day; visit 3, approx. 7 days post treatment; visit 4, approx.14 days post treatment; visit 5, approx. 28 days post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to use PDT to treat actinic keratosis, a skin condition caused by too much sun exposure. They will use a new gel and lamp to see if it is safe and works well.
Eligible Conditions
- Actinic Keratosis
- Keratoderma Blennorrhagicum
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all visits through study completion after visit 1: visit 2, baseline, treatment day; visit 3, approx. 7 days post treatment; visit 4, approx.14 days post treatment; visit 5, approx. 28 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all visits through study completion after visit 1: visit 2, baseline, treatment day; visit 3, approx. 7 days post treatment; visit 4, approx.14 days post treatment; visit 5, approx. 28 days post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Application Site Discomfort During and Post PDT, Reported by the Subjects
Application Site Pain During Illumination
Application Site Skin Reactions During and Post PDT, Assessed by the Investigator
+13 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 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
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BF-200 ALAExperimental Treatment1 Intervention
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
One single 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
1,711 Total Patients Enrolled
Todd Schlesinger, MDPrincipal InvestigatorClinical Research Center of the Carolinas, 1364 Ashley River Road, Charleston, SC 29407, USA
1 Previous Clinical Trials
16 Total Patients Enrolled