Actinic KeratosesPhase 1NCT07053852
Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
A Phase 1 study testing Ameluz and Sciton HEROic in people with Actinic Keratoses and Photodamage, run by Sherrif Ibrahim at 1 site in United States.
Trial summary
To provide a treatment of both actinic keratoses and photodamage within one treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses, Photodamage
- What is being tested?
- Ameluz and Sciton HEROic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to 29 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- Solar lentigines
- Telangiectasias
- Diffuse erythema
- Roughness and other textural changes
- Fine lines
- Wrinkles
- Actinic bronzing
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rochester Dermatologic Surgery
Victor, New York, 14564
About this study
To provide a treatment of both actinic keratoses and photodamage within one treatment.
Read the 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.
- Conditions
- Actinic Keratoses, Photodamage
- Being tested
- Ameluz, Sciton HEROic
- Keywords
- aging face, actinic keratosis, BBL, PDT, photodynamic therapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmeluzDrug
broad band light (BBL) with the use of Ameluz
Sciton HEROicDevice
Also called BBL
Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ameluz; Device: Sciton HEROic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 2 months
Secondary 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 using a Visia camera analysis.
Measured: 2 months
Cosmetic outcomes
Cosmetic outcomes in photoaging of the face evaluated a Visia camera analysis at 1 and 2 months post last PDT
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start27 Jun 2025
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherrif Ibrahim
- Sponsor type
- University, hospital or other
- Collaborators
- Sciton, Biofrontera Bioscience GmbH
- Responsible party
- Sponsor-investigator, Sherrif Ibrahim, Rochester Dermatologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053852
- Sponsor's protocol ID
- BF-BBL-01
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
- ClinicalTrials.gov ID
- NCT07053852
- Acronym / sponsor ID
- BF-BBL-01
- Conditions
- Actinic Keratoses, Photodamage
- Keywords
- aging face, actinic keratosis, BBL, PDT, photodynamic therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sherrif IbrahimUniversity, hospital or other
- Collaborators
- Sciton, Biofrontera Bioscience GmbH
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two PDT treatments | Experimental | Drug: Ameluz, Device: Sciton HEROicEach subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ameluzbroad band light (BBL) with the use of Ameluz | Drug | Two PDT treatments |
| Sciton HEROicAlso: BBLEach subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. | Device | Two PDT treatments |
Primary outcome
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.
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)
2 secondary outcomes
Percentage of clearance of actinic keratoses
Time frame: 2 months
Cosmetic outcomes
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ameluz and Sciton HEROic in people with Actinic Keratoses and Photodamage, run by Sherrif Ibrahim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of clearance of actinic keratoses (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.