Clinical trial NCT06745999: Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Actinic Keratoses
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Biofrontera Bioscience GmbH
First posted: 2024-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. 6-12 actinic keratosis grade I, II, and III on the full face.
3. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during study participation.
4. 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.
5. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

1. 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.
2. 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.
3. Use of liquid nitrogen, excision, curettage, dermabrasion, chemical peel or laser resurfacing in the treatment area within 60 days.
4. Use of systemic retinoids (eg, isotretinoin, acitretin) within 6 months
5. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
6. Use of any investigational drug within 4 weeks prior to enrollment or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
7. 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.

Primary outcomes:
measure: Percentage change in total lesions at Week 24
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of New Jersey
state: New Jersey
Study officials:
References: