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

NCT06745999 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: PTC11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage change in total lesions at Week 24

  Percentage change From Baseline in Total Lesion Complete Response at Week 24

  24 Weeks

Study Arms (2)

cryotherapy followed by 10% ALA gel Red light PDT

EXPERIMENTAL

Drug: Ameluz 10% Topical Gel; Device: Red Light PDT; Procedure: Cryotherapy

10% ALA gel Red Light PDT followed by cryotherapy

EXPERIMENTAL

Drug: Ameluz 10% Topical Gel; Device: Red Light PDT; Procedure: Cryotherapy

Interventions

Ameluz 10% Topical Gel DRUG

Paired with device intervention of red light PDT

Also known as: ALA gel

10% ALA gel Red Light PDT followed by cryotherapy; cryotherapy followed by 10% ALA gel Red light PDT

Red Light PDT DEVICE

Paired with drug intervention of Ameluz 10% topical gel

10% ALA gel Red Light PDT followed by cryotherapy; cryotherapy followed by 10% ALA gel Red light PDT

Cryotherapy PROCEDURE

Liquid Nitrogen

10% ALA gel Red Light PDT followed by cryotherapy; cryotherapy followed by 10% ALA gel Red light PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult ≥ 18 years of age;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead
• Biofrontera Bioscience GmbH: collaborator

Study Sites (1)

Psoriasis Treatment Center of New Jersey

East Windsor, New Jersey, 08520, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; Gels; Photochemotherapy; Cryotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Central Study Contacts

Ashley Reed

CONTACT

609-443-4500; ashley.reed@schweigerderm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: May 3, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-03

Locations

US (1)