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

Phase 4

Recruiting

• Conditions: Actinic Keratoses
• Interventions: Drug: Ameluz 10% Topical Gel; Device: Red Light PDT; Procedure: Cryotherapy

• Registration Number: NCT06745999
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-03
• Status Verified: 2024-03
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cryotherapy followed by 10% ALA gel Red light PDT	Ameluz 10% Topical Gel	-
cryotherapy followed by 10% ALA gel Red light PDT	Red Light PDT	-
cryotherapy followed by 10% ALA gel Red light PDT	Cryotherapy	-
10% ALA gel Red Light PDT followed by cryotherapy	Ameluz 10% Topical Gel	-
10% ALA gel Red Light PDT followed by cryotherapy	Red Light PDT	-
10% ALA gel Red Light PDT followed by cryotherapy	Cryotherapy	-

Primary Outcome Measures

Name	Time	Method
Percentage change in total lesions at Week 24	24 Weeks	Percentage change From Baseline in Total Lesion Complete Response at Week 24

Trial Locations

Locations (1)

Psoriasis Treatment Center of New Jersey; 🇺🇸 East Windsor, New Jersey, United States