Conditions

Acne Vulgaris

Keywords

ALA-PDT

Outcome Measures

Primary Outcomes (2)

Relative Change in the Number of Inflammatory Lesions (Relative Change From Baseline) 8 Weeks After the Last PDT as Assessed by Investigator.
Outcome 1 is the relative change in the number of inflammatory lesions at the final visit with respect to baseline as assessed by the investigator.
8 weeks after the last PDT
Treatment Success Defined by a Minimum Improvement of the Modified Investigator Global Assessment (mIGA) Score by at Least 2 Assessed 8 Weeks After the Last PDT and Resulting in an mIGA Score of 0 (Clear) or 1 (Almost Clear).
Treatment success is defined as a minimum improvement of the mIGA score by at least 2 and resulting in an mIGA score of 0 (clear) or 1 (almost clear).
8 weeks after the last PDT

Secondary Outcomes (17)

Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator (After the Last PDT).
4 or 8 weeks after the last PDT
Percentage Change From Baseline in the Number of Lesions as Assessed by Investigator (After the Last PDT).
4 or 8 weeks after the last PDT
Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator (After Each PDT).
4 or 8 weeks after the last PDT
Percentage Change From Baseline in the Number of Lesions as Assessed by Investigator (After Each PDT).
4 or 8 weeks after the last PDT
Absolute Change From Baseline in the Number of Lesions as Assessed by Investigator, Only for Responders at Visit 3 / 4 Weeks After PDT-1.
4 or 8 weeks after PDT-1
+12 more secondary outcomes

Other Outcomes (10)

Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), AEs of Special Interest (AESI) and Treatment-emerged Adverse Events (TEAEs).
from screening to study completion, over a duration of up to approximately 25 weeks
Application Site Skin Reaction Assessed by Investigator
During illumination (10 minutes) at PDT-1, PDT-2, and PDT-3
Application Site Discomfort Reported by the Subjects.
During illumination (10 minutes) at PDT-1, PDT-2, and PDT-3
+7 more other outcomes

Study Arms (4)

1h incubation BF-200 ALA

EXPERIMENTAL

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.

Combination Product: 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)

3h incubation BF-200 ALA

EXPERIMENTAL

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.

Combination Product: 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)

1h incubation vehicle

PLACEBO COMPARATOR

Interventions

1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)Combination product

The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 1 hour. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps). Other Names: ALA-PDT, Ameluz®-PDT

1h incubation BF-200 ALA

1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)Combination product

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Willingness and ability of the subject to provide informed consent and to sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures. Minors under 18 years of age must be accompanied by the parent(s) or legal guardian(s) at the time of consent signing. The parent(s) or legal guardian(s) must also provide informed consent/HIPAA for the subject.

Sponsors & Collaborators

Biofrontera Inc.
Industrylead

Study Sites (9)

First OC Dermatology

Fountain Valley, California, 92708, United States

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Dermatology Associates PA of the Palm Beaches

Delray Beach, Florida, 33445, United States

ForCare Clinical Research

Tampa, Florida, 17033, United States

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Skin Search of Rochester, Inc

Rochester, New York, 14623, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

MeSH Terms

Conditions

Acne Vulgaris

Interventions

1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Results Point of Contact

Title: Clinical Trial Management
Organization: Biofrontera Discovery GmbH

Study Officials

Mitchel P Goldman, MD
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (17)

Other Outcomes (10)

Study Arms (4)

1h incubation BF-200 ALA

3h incubation BF-200 ALA

1h incubation vehicle

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

3h incubation vehicle

You may not qualify if:

Source record

Documents

Locations