Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face

Launched by PSORIASIS TREATMENT CENTER OF CENTRAL NEW JERSEY · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment for actinic keratosis, which are rough, scaly spots on the skin caused by sun damage. The study is comparing two different approaches: one group of participants will receive cryotherapy (a freezing treatment) followed by a special light therapy using a gel, while the other group will receive the light therapy first and then cryotherapy. The goal is to determine which method is more effective in treating these skin conditions.

To participate, individuals must be at least 18 years old and have 6 to 12 actinic keratosis spots on their face. Participants should be willing to avoid excessive sun exposure during the study. It's important to note that those with certain other skin conditions or who have recently used specific treatments for actinic keratosis may not be eligible. If you join the study, you can expect to receive either of the treatment sequences and will be monitored closely throughout the trial. This research is currently recruiting participants of all genders, aged between 65 and 74.

Gender

ALL

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.