Actinic KeratosisPhase 2NCT06027619

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

A Phase 2 study testing Topical aminolevulinate (10% ALA gel) and Red light illumination in people with Actinic Keratosis, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Actinic Keratosis
What is being tested?: Topical aminolevulinate (10% ALA gel) and Red light illumination
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 2 Oct 2023to 8 Jul 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Minimum of 10 actinic keratoses lesions on the face.
Female subjects must not become pregnant during the study
Subjects must be able to understand and willing to sign a written informed consent document.

Who cannot join

Pregnant or nursing.
Using any topical treatment on their AKs; must stop at least one month prior.
Currently undergoing treatment for other cancers with medical or radiation therapy.
Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)

Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance?
Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance?
Will the new test regimens achieve reduced pain during illumination?
Will the new test regimens be safe?

Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.

Conditions: Actinic Keratosis
Being tested: Topical aminolevulinate (10% ALA gel), Red light illumination
Keywords: Actinic Keratoses, Actinic Keratosis, 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.

Topical aminolevulinate (10% ALA gel)Drug
Also called Ameluz gel, 10% aminolevulinic acid
10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period
Red light illuminationDevice
Also called BF-RhodoLED® Light Source
Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2

Study groups in NCT06027619
Study group	Role	What they receive
Regimen A	Experimental	Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Receives: Drug: Topical aminolevulinate (10% ALA gel); Device: Red light illumination
Regimen B	Experimental	Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Receives: Drug: Topical aminolevulinate (10% ALA gel); Device: Red light illumination
Regimen C	Experimental	Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Receives: Drug: Topical aminolevulinate (10% ALA gel); Device: Red light illumination

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Efficacy Based on Participant AK Lesion Clearance
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
Measured: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
Differences in Pain Level Reported Throughout Exposure to Red Light
Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain)
Measured: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2)

Secondary outcomes (3)

Patient Satisfaction Survey as Measured by Treatment Outcome Score
Treatment score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.
Measured: 6 months
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score
Cosmetic score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.
Measured: At month 6
Number of Participant Reported Adverse Events and Side Effects
Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.
Measured: Up to 6 days (Day 6) after Visit 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 20238 Jul 2024

First posted7 Sep 2023
Study start2 Oct 2023
Primary completion8 Jul 2024
Study completion8 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Actinic KeratosisStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06027619
Sponsor's protocol ID: CASE4623
Status last verified: Aug 2025
First submitted: 31 Aug 2023
Last updated: 23 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes

Publications

Johnson JS, Hanna J, Nowacki AS, Anand S, Shen AS, Maytin EV. Painless PDT using 10% aminolevulinate gel and red light: A pilot clinical trial of short-contact protocols to reduce discomfort during illumination. Photodiagnosis Photodyn Ther. 2025 Aug;54:104698. doi: 10.1016/j.pdpdt.2025.104698. Epub 2025 Jun 26.
PubMed 40581198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

All Actinic Keratosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)
ClinicalTrials.gov ID: NCT06027619
Acronym / sponsor ID: CASE4623
Conditions: Actinic Keratosis
Keywords: Actinic Keratoses, Actinic Keratosis, Photodynamic Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: The Cleveland Clinic, Biofrontera Inc.
Study start: 2 Oct 2023 (actual)
Primary completion: 8 Jul 2024 (actual)
Study completion: 8 Jul 2024 (actual)
First posted: 7 Sep 2023 (actual)
Results: Posted 23 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance?
Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance?
Will the new test regimens achieve reduced pain during illumination?
Will the new test regimens be safe?

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Regimen A	Experimental	Drug: Topical aminolevulinate (10% ALA gel), Device: Red light illuminationApply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source
Regimen B	Experimental	Drug: Topical aminolevulinate (10% ALA gel), Device: Red light illuminationApply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source
Regimen C	Experimental	Drug: Topical aminolevulinate (10% ALA gel), Device: Red light illuminationApply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Minimum of 10 actinic keratoses lesions on the face.
Female subjects must not become pregnant during the study
Subjects must be able to understand and willing to sign a written informed consent document.

Key exclusion criteria (5 listed)

Pregnant or nursing.
Using any topical treatment on their AKs; must stop at least one month prior.
Currently undergoing treatment for other cancers with medical or radiation therapy.
Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

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
Topical aminolevulinate (10% ALA gel)Also: Ameluz gel, 10% aminolevulinic acid10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period	Drug	Regimen A, Regimen B, Regimen C
Red light illuminationAlso: BF-RhodoLED® Light SourceIllumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Device	Regimen A, Regimen B, Regimen C

Primary outcome

Treatment Efficacy Based on Participant AK Lesion Clearance
Time frame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)
To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.
Differences in Pain Level Reported Throughout Exposure to Red Light
Time frame: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2)
Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain)

3 secondary outcomes

Patient Satisfaction Survey as Measured by Treatment Outcome Score
Time frame: 6 months
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score
Time frame: At month 6
Number of Participant Reported Adverse Events and Side Effects
Time frame: Up to 6 days (Day 6) after Visit 1

Results and safety

Results posted to the registry on 23 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen A	10	10
Regimen B	10	10
Regimen C	10	9

Primary outcome: Treatment Efficacy Based on Participant AK Lesion Clearance

Time frame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6). Number. Unit: percentage of AK lesions

Measure	Regimen A n = 10	Regimen B n = 10	Regimen C n = 9
Lesion clearance rate at Visit 3	59	34	43
Lesion clearance rate at Visit 4	76	74	82

Primary outcome: Differences in Pain Level Reported Throughout Exposure to Red Light

Time frame: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2). Mean (Standard Error). Unit: score on a scale

Measure	Regimen A n = 10	Regimen B n = 10	Regimen C n = 9
Pain at visit 1	0.70 (0.32)	0.10 (0.11)	4.7 (0.65)
Pain at visit 3	0.20 (0.21)	0.30 (0.16)	2.22 (0.68)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Regimen B	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Regimen C	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40581198Johnson JS, Hanna J, Nowacki AS, Anand S, Shen AS, Maytin EV. Painless PDT using 10% aminolevulinate gel and red light: A pilot clinical trial of short-contact protocols to reduce discomfort during illumination. Photodiagnosis Photodyn Ther. 2025 Aug;54:104698. doi: 10.1016/j.pdpdt.2025.104698. Epub 2025 Jun 26.
Individual participant dataSharing planned: Yes

Related trials for Actinic Keratosis

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

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.

Edward V Maytin, M.D. Ph.D. principal investigator

Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topical aminolevulinate (10% ALA gel) and Red light illumination in people with Actinic Keratosis, run by Case Comprehensive Cancer Center 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 3 inclusion and 5 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 23 Oct 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Treatment Efficacy Based on Participant AK Lesion Clearance (time frame: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)). 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?

On the ClinicalTrials.gov record for NCT06027619, which also lists 1 linked publication.

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 23 Oct 2025.