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Photosensitizer

BF-200 ALA and red light LED lamp for Actinic Keratosis

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 at screening (up to 14 days before treatment) and at visit 5 (approx. 28 days post treatment)
Awards & highlights

Study 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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening (up to 14 days before treatment) and at visit 5 (approx. 28 days post treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening (up to 14 days before treatment) and at visit 5 (approx. 28 days post treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 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 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

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
~150

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05060237.
~30 spots leftby Apr 2025
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