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Photosensitizer
Photodynamic Therapy for Acne
Phase 2
Recruiting
Led By Mitchel P Goldman, 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 ≥20 inflammatory and ≥20 non-inflammatory Acne vulgaris lesions on the face
Females of reproductive potential must have a negative serum pregnancy test and must use adequate and highly effective or two effective methods of contraception throughout the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first and last visit conducted up to approximately 25 weeks apart
Awards & highlights
Study Summary
This trial tests whether a light-based therapy is effective and safe for treating moderate to severe acne.
Who is the study for?
Adults with moderate to severe facial acne (IGA ≥3), willing to stop other topical treatments and able to undergo up to 3 photodynamic therapies in 8-10 weeks. Participants must be generally healthy, females using contraception, and over 16 years old. Excluded are those allergic to ALA or ingredients in BF-200 ALA, have certain skin conditions or facial hair that affects study assessments unless they shave.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Ameluz® with BF-RhodoLED® lamp for treating acne through photodynamic therapy (PDT). It compares a one-hour and three-hour PDT session using Ameluz® against a placebo treatment without active ingredients.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the site of application such as redness, swelling, burning sensation; sensitivity to light; temporary changes in skin color; itching; scaling; dryness; stinging sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have more than 20 red and 20 non-red acne spots on my face.
Select...
I am not pregnant and will use effective birth control during the study.
Select...
I have moderate to severe facial acne.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 or 8 weeks after the last pdt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 or 8 weeks after the last pdt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative change in the number of inflammatory lesions (relative change from baseline) 8 weeks after the last PDT as assessed by investigator.
Photochemotherapy
Secondary outcome measures
Change in the number of inflammatory and/or non-inflammatory lesions (absolute change and/or percentage change from baseline) as assessed by investigator.
Change in the number of inflammatory and/or non-inflammatory lesions (absolute change and/or percentage change from baseline) as assessed by the Canfield algorithm
Inflammation
+8 moreOther outcome measures
Application site discomfort reported by the subjects.
Application site skin reactions assessed by the investigator.
Changes in blood pressure
+7 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 3h incubation BF-200 ALAExperimental Treatment1 Intervention
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation.
Group II: 1h incubation BF-200 ALAExperimental Treatment1 Intervention
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.
Group III: 3h incubation vehiclePlacebo Group1 Intervention
Topical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation.
Group IV: 1h incubation vehiclePlacebo Group1 Intervention
Topical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.
Find a Location
Who is running the clinical trial?
Biofrontera Bioscience GmbHLead Sponsor
10 Previous Clinical Trials
1,685 Total Patients Enrolled
Mitchel P Goldman, MDPrincipal InvestigatorDermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
12 Previous Clinical Trials
363 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had facial treatments like peels or been in strong sunlight for 4 weeks.You have had a bad reaction to ALA, porphyrins, or other ingredients in the study medication BF-200 ALA.There is a concern that you may be using drugs or alcohol excessively.I cannot avoid the sun for 2 days after my PDT treatment.You have artificial pigmentation or any other abnormality that could affect how well the treatment works on your skin.I am in good health or have stable health conditions.I have sunburn or skin issues near the treatment area.I agree to shave my beard or facial hair for the study.I have not had a fever or infection in the last week.I have four or more bumps from acne on my face.I have a skin condition like eczema, psoriasis, or a type of skin cancer.I have used skin medication before screening.I am willing and able to give my consent and sign the HIPAA form.I am willing to stop using facial treatments except for medical cleansers 14 days before the study starts, and stop all cleansers 1 week before.I will take a medication that reacts to light before my next light therapy session.I have more than 20 red and 20 non-red acne spots on my face.I haven't used any steroid creams in the week before my PDT appointment.You have had an allergic reaction to soy or peanuts in the past.I am 16 years old or older.I am not pregnant and will use effective birth control during the study.I have not used certain medications recently.If I am under 18, my parent or guardian will be with me to sign the consent.I have moderate to severe facial acne.I am willing to follow the study's requirements, including up to 3 treatments within 8-10 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: 3h incubation BF-200 ALA
- Group 2: 3h incubation vehicle
- Group 3: 1h incubation vehicle
- Group 4: 1h incubation BF-200 ALA
Awards:
This trial has 0 awards, including: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.
Is there still an opportunity for participants to join this research endeavor?
"Affirmative. Clinicaltrials.gov records confirm that this medical investigation, initially posted on December 10th 2021, is actively recruiting participants. Approximately 126 people are required to take part in the study across 7 distinct sites."
Answered by AI
What objectives is this clinical experiment attempting to accomplish?
"This clinical trial will be evaluated for a period of 8 weeks after the last PDT, with the primary objective being an absolute change in inflammatory lesions from baseline. Secondary objectives include changes to both inflammatory and non-inflammatory lesions from baseline (for subjects who receive 2 or 3 PDTs), patient satisfaction regarding esthetic outcomes, and changes in inflammatory/non-inflammatory lesions from baseline (for those receiving two PSTDs)."
Answered by AI
What maladies is 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) typically prescribed for?
"3h Incubation Photodynamic therapy (PDT) also known as ALA-PDT, Ameluz®-PDT is a viable treatment for scalp structure carcinoma and squamous cell carcinoma."
Answered by AI
What results have been yielded by prior experiments utilizing 3h Incubation Photodynamic therapy (PDT) such as ALA-PDT and Ameluz®-PDT?
"In 2013, Tel Aviv Sourasky Medical Centre began the first clinical trial of 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT). Since then, 52 studies have been completed and 18 are still ongoing. Notably, a substantial number of these trials take place in San Diego."
Answered by AI
What potential perils are associated with the utilization of 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)?
"Our Power team has assigned a 2 to 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) due to the safety data which is available from Phase 2 trials yet efficacy remains untested."
Answered by AI
What upper limit of participants has been established for this investigation?
"This trial necessitates the recruitment of 126 eligible participants, with two specific sites - Cosmetic Laser Dermatology in California and First OC Dermatology in New york."
Answered by AI
How many trial locations are currently offering this research project?
"Currently, this medical trial is being conducted across 7 sites. San Diego, Fountain Valley and Rochester are included amongst the locations offering it; 4 additional sites exist to minimize travel discomfort for enrollees."
Answered by AI
Who else is applying?
What site did they apply to?
Cosmetic Laser Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I've tried accutane 2x within 5-10 years ago, numerous oral medictions, lotions, creams, serums, birth control etc. still breaking out.
PatientReceived 1 prior treatment
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