Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face
NCT ID: NCT06745999
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2023-05-03
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cryotherapy followed by 10% ALA gel Red light PDT
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
10% ALA gel Red Light PDT followed by cryotherapy
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Biofrontera Bioscience GmbH
INDUSTRY
Psoriasis Treatment Center of Central New Jersey
OTHER
Responsible Party
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Locations
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Psoriasis Treatment Center of New Jersey
East Windsor, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Reed
Role: primary
Jerry Bagel, MD, MS
Role: backup
David Nieves, MD
Role: backup
Alexa Hetzel, PA-C
Role: backup
Kristen Teixeria, PA-C
Role: backup
Other Identifiers
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PTC11
Identifier Type: -
Identifier Source: org_study_id