Actinic Keratoses
Conditions
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.
Interventions
Paired with device intervention of red light PDT
DEVICERed Light PDT
Paired with drug intervention of Ameluz 10% topical gel
PROCEDURECryotherapy
Liquid Nitrogen
Sponsors
Biofrontera Bioscience GmbH
Psoriasis Treatment Center of Central New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in total lesions at Week 24 | 24 Weeks | Percentage change From Baseline in Total Lesion Complete Response at Week 24 |
Countries
United States
Contacts
Primary ContactAshley Reed
Outcome results
None listed