Recruiting

Cryotherapy & PDT

Sponsor:

Psoriasis Treatment Center of Central New Jersey

Code:

NCT06745999

Conditions

Actinic Keratoses

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ameluz 10% Topical Gel

Red Light PDT

Cryotherapy

Study Details

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.

Conditions

Actinic Keratoses

Study ID

NCT06745999

Start date

May 3, 2023

Status verified date

Mar, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cryotherapy followed by 10% ALA gel Red light PDT

experimental: 10% ALA gel Red Light PDT followed by cryotherapy

Interventions

Ameluz 10% Topical Gel

Paired with device intervention of red light PDT

Red Light PDT

Paired with drug intervention of Ameluz 10% topical gel

Cryotherapy

Liquid Nitrogen

Primary outcome measure

  • Percentage change in total lesions at Week 24 [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Locations

Psoriasis Treatment Center of New Jersey

Recruiting

East Windsor, New Jersey, United States, 08520

Contacts

More Information

Sponsor

Psoriasis Treatment Center of Central New Jersey

Last update posted

Dec 24, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Psoriasis Treatment Center of Central New Jersey on 2024-12-24.