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
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