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OpenTrials
Completed

NCT Number: NCT07053852

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rochester Dermatologic Surgery

Victor, New York, 14564, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ameluz

Drug

broad band light (BBL) with the use of Ameluz

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.

Other names: BBL

Primary outcomes

  1. Percentage of clearance of actinic keratoses

    Time frame: 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.

  2. Cosmetic outcomes

    Time frame: 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.

    Scale: Very Satisfied (better than expected), Satisfied (as expected), Unsatisfied (worse than expected)

Secondary outcomes

  1. Percentage of clearance of actinic keratoses

    Time frame: 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.

  2. Cosmetic outcomes

    Time frame: 2 months

    Cosmetic outcomes in photoaging of the face evaluated a Visia camera analysis at 1 and 2 months post last PDT

Sponsors and collaborators

Lead sponsor

Sherrif Ibrahim

Other

Collaborators

  • Biofrontera Bioscience GmbH
  • Sciton

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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