Actinic KeratosesPhase 4NCT06745999
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
A Phase 4 study testing Ameluz 10% Topical Gel, Red Light PDT and Cryotherapy in people with Actinic Keratoses, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Ameluz 10% Topical Gel, Red Light PDT and Cryotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Male or female adult ≥ 18 years of age;
- 6-12 actinic keratosis grade I, II, and III on the full face.
- Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during study participation.
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- Able and willing to give written informed consent prior to performance of any study-related procedures
Who cannot join
- Presence of other skin conditions that may affect the study participant, investigator's ability to assess treatment, or intolerance to any ingredient in 10% ALA gel.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topicals and treatments for AK within the treatment area or within 2 cm of the treatment area, within 12 weeks of baseline.
- Use of liquid nitrogen, excision, curettage, dermabrasion, chemical peel or laser resurfacing in the treatment area within 60 days.
- Use of systemic retinoids (eg, isotretinoin, acitretin) within 6 months
- Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
- Use of any investigational drug within 4 weeks prior to enrollment or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psoriasis Treatment Center of New Jersey
East Windsor, New Jersey, 08520
About this study
Official title: A Single Center, Observational Study to Evaluate the Effectiveness and Safety of Cryotherapy in Combination With 10% ALA Gel Red Light PDT in the Treatment of Actinic Keratosis on the Full Face.
40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy.
- Conditions
- Actinic Keratoses
- Being tested
- Ameluz 10% Topical Gel, Red Light PDT, Cryotherapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ameluz 10% Topical GelDrug
Also called ALA gel
Paired with device intervention of red light PDT
Red Light PDTDevice
Paired with drug intervention of Ameluz 10% topical gel
CryotherapyProcedure or surgery
Liquid Nitrogen
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy followed by 10% ALA gel Red light PDT | Experimental | Not described Receives: Drug: Ameluz 10% Topical Gel; Device: Red Light PDT; Procedure: Cryotherapy |
| 10% ALA gel Red Light PDT followed by cryotherapy | Experimental | Not described Receives: Drug: Ameluz 10% Topical Gel; Device: Red Light PDT; Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in total lesions at Week 24
Percentage change From Baseline in Total Lesion Complete Response at Week 24
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 May 2023
- Primary completion13 Oct 2026 (estimated)
- Study completionNov 2026 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Biofrontera Bioscience GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745999
- Sponsor's protocol ID
- PTC11
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Observational Study to Evaluate the Effectiveness and Safety of Cryotherapy in Combination With 10% ALA Gel Red Light PDT in the Treatment of Actinic Keratosis on the Full Face.
- ClinicalTrials.gov ID
- NCT06745999
- Acronym / sponsor ID
- PTC11
- Conditions
- Actinic Keratoses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- Biofrontera Bioscience GmbH
- Study start
- 3 May 2023 (actual)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Dec 2024 (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.
40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryotherapy followed by 10% ALA gel Red light PDT | Experimental | Drug: Ameluz 10% Topical Gel, Device: Red Light PDT, Procedure: Cryotherapy |
| 10% ALA gel Red Light PDT followed by cryotherapy | Experimental | Drug: Ameluz 10% Topical Gel, Device: Red Light PDT, Procedure: Cryotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adult ≥ 18 years of age;
- 6-12 actinic keratosis grade I, II, and III on the full face.
- Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during study participation.
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- Able and willing to give written informed consent prior to performance of any study-related procedures
Key exclusion criteria (7 listed)
- Presence of other skin conditions that may affect the study participant, investigator's ability to assess treatment, or intolerance to any ingredient in 10% ALA gel.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topicals and treatments for AK within the treatment area or within 2 cm of the treatment area, within 12 weeks of baseline.
- Use of liquid nitrogen, excision, curettage, dermabrasion, chemical peel or laser resurfacing in the treatment area within 60 days.
- Use of systemic retinoids (eg, isotretinoin, acitretin) within 6 months
- Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
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 |
|---|---|---|
| Ameluz 10% Topical GelAlso: ALA gelPaired with device intervention of red light PDT | Drug | 10% ALA gel Red Light PDT followed by cryotherapy, cryotherapy followed by 10% ALA gel Red light PDT |
| Red Light PDTPaired with drug intervention of Ameluz 10% topical gel | Device | 10% ALA gel Red Light PDT followed by cryotherapy, cryotherapy followed by 10% ALA gel Red light PDT |
| CryotherapyLiquid Nitrogen | Procedure or surgery | 10% ALA gel Red Light PDT followed by cryotherapy, cryotherapy followed by 10% ALA gel Red light PDT |
Primary outcome
Percentage change in total lesions at Week 24
Time frame: 24 Weeks
Percentage change From Baseline in Total Lesion Complete Response at Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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 4 study testing Ameluz 10% Topical Gel, Red Light PDT and Cryotherapy in people with Actinic Keratoses, run by Psoriasis Treatment Center of Central New Jersey 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 change in total lesions at Week 24 (time frame: 24 Weeks). 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 14 Oct 2026.