Cryotherapy combined with red light therapy for treating actinic keratosis on the face
A Single Center, Observational Study to Evaluate the Effectiveness and Safety of Cryotherapy in Combination with 10% ALA Gel Red Light PDT in the Treatment of Actinic Keratosis on the Full Face.
This study is testing whether combining cryotherapy with red light therapy can help people with multiple actinic keratosis spots on their faces get better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Psoriasis Treatment Center of Central New Jersey Academic / other |
| Locations | 1 site (East Windsor, New Jersey) |
| Trial ID | NCT06745999 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 40 patients who will be randomly assigned to receive either cryotherapy followed by a topical gel and red light photodynamic therapy (PDT) or the reverse order. The aim is to evaluate the effectiveness of this combination treatment for actinic keratosis, a skin condition caused by sun damage. Participants will be monitored for their response to the treatments and any side effects experienced. The study focuses on patients with multiple actinic keratosis lesions on their faces.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with 6-12 actinic keratosis lesions of grades I, II, and III on their full face.
Not a fit: Patients with other skin conditions that may interfere with the assessment of treatment effectiveness will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide an effective solution for patients suffering from actinic keratosis, potentially improving skin health and reducing lesion recurrence.
How similar studies have performed: While this specific combination of treatments is being evaluated, similar approaches using cryotherapy and photodynamic therapy have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
East Windsor, New Jersey
- Psoriasis Treatment Center of New Jersey — East Windsor, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Ashley Reed
- Email: ashley.reed@schweigerderm.com
- Phone: 609-443-4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.