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

Sherrif Ibrahim

Status and phase: Completed; Phase 1

Conditions: Photodamage; Actinic Keratoses

Treatments: Drug: Ameluz; Device: Sciton HEROic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07053852

BF-BBL-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Two PDT treatments

Experimental group

Description:

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

Treatment:

Device: Sciton HEROic

Drug: Ameluz