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

Not Applicable

Recruiting

• Conditions: Actinic Keratoses; Photodamage
• Interventions: Drug: Ameluz; Device: Sciton HEROic

• Registration Number: NCT07053852
• Lead Sponsor: Sherrif Ibrahim

Brief Summary

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

Detailed Description

To demonstrate that treatment of actinic keratoses and photodamage with a combination of Ameluz and Broad Band Light (BBL) will lead to an improvement in facial precancerous change and signs of photodamage.

Study Timeline

• Study First Submitted: 2025-02-05
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study Start: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Two PDT treatments	Ameluz	Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.
Two PDT treatments	Sciton HEROic	Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.

Primary Outcome Measures

Name	Time	Method
Percentage of clearance of actinic keratoses	2 months	Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face.
Cosmetic outcomes	2 months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of clearance of actinic keratoses	2 months	Percentage of actinic keratosis lesion clearance at 1 and 2 months after 2 treatments with the combination of Ameluz and BBL on the face using a Visia camera analysis.
Cosmetic outcomes	2 months	Cosmetic outcomes in photoaging of the face evaluated a Visia camera analysis at 1 and 2 months post last PDT

Trial Locations

Locations (1)

Rochester Dermatologic Surgery; 🇺🇸 Victor, New York, United States