Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage

NCT07053852 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: BF-BBL-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To provide a treatment of both actinic keratoses and photodamage within one treatment.

Conditions

Actinic Keratoses; Photodamage

Keywords

aging face; actinic keratosis; BBL; PDT; photodynamic therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of clearance of actinic keratoses

  Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face.

  2 months

• Cosmetic outcomes

  Cosmetic outcomes in photoaging of the face evaluated by Subject and Investigator Global Aesthetic Improvement Scale (GAIS) at 1 and 2 months post last PDT. Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected)

  2 months

Secondary Outcomes (2)

• Percentage of clearance of actinic keratoses

  2 months

• Cosmetic outcomes

  2 months

Study Arms (1)

Two PDT treatments

EXPERIMENTAL

Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.

Drug: Ameluz; Device: Sciton HEROic

Interventions

Ameluz DRUG

broad band light (BBL) with the use of Ameluz

Two PDT treatments

Sciton HEROic DEVICE

Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.

Also known as: BBL

Two PDT treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18yrs of age
• Willingness to participate in all required study activities and visits
• Willingness to sign the informed consent form
• Visible and palpable signs of diffuse actinic damage and actinic keratoses of mild to moderate severity located on the face
• Significant signs of photoaging, evaluated by investigator, that include any or all the following:
• Dyspigmentation
• Solar lentigines
• Telangiectasias
• Diffuse erythema
• Roughness and other textural changes
• Fine lines
• Wrinkles
• Actinic bronzing

You may not qualify if:

• Subject who is unable and unwilling to provide consent for study schedule and procedures
• Subject who is pregnant or trying to become pregnant during the study
• Subjects using any topical treatment on their AKs; must stop at least one month prior
• Subjects currently undergoing cancer treatment with medical or radiation therapy
• Subjects with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
• Subjects with history of a photosensitivity disease, such as porphyria cutanea tarda

Sponsors & Collaborators

• Sherrif Ibrahim: lead
• Sciton: collaborator
• Biofrontera Bioscience GmbH: collaborator

Study Sites (1)

Rochester Dermatologic Surgery

Victor, New York, 14564, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: July 8, 2025
• Study Start: June 27, 2025
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)