Using Aminolevulinic Acid and Light Therapy to Treat and Prevent Facial Actinic Keratosis
Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention: A Long-term (3 Years) Follow-up of Prospective, Randomized, Multicenter-clinical Trial
This study is testing if a special light therapy combined with a medication can help treat and prevent new spots of actinic keratosis on the face for people who already have them.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Dermatology Hospital Academic / other |
| Locations | 1 site (Shanghai, Jingan) |
| Trial ID | NCT03642535 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of aminolevulinic acid photodynamic therapy (ALA-PDT) in treating facial actinic keratosis (AK) by targeting areas of field change rather than individual lesions. Eighty patients diagnosed with AKs will be randomized into two groups: one receiving ALA-PDT for field treatment and the other receiving treatment on a specific lesion area. The study aims to determine if this approach can prevent the development of new AKs over a five-year follow-up period. The trial is designed to address the field nature of AKs, potentially reducing the risk of recurrence and new lesions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with clinically diagnosed actinic keratosis who are unfit for surgery.
Not a fit: Patients with other facial diseases affecting treatment efficacy or those who have recently undergone similar therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of new actinic keratosis lesions and improve long-term skin health for patients.
How similar studies have performed: Previous studies have shown promise with photodynamic therapy for actinic keratosis, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosed with AK (OLSEN classification grade I, II, III), aged \> 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients \<18 years of age, children are excluded from this study); 2. All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents are willing to pay for the treatment, and agreed to take a picture of the skin lesions. Exclusion Criteria: 1. Those who had ALA-PDT and any other studies that affect this study within 12 weeks ; 2. There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis; 3. Take phototoxic or photosensitizer within 8 weeks; 4. Clinical and / or pathological prove that the tumor has invaded other organs or tissues; 5. Serious immunocompromised persons; 6. scar constitution; 7. Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine; 8. Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.
Where this trial is running
Shanghai, Jingan
- Shanghai Dermatology Hospital — Shanghai, Jingan, China (Recruiting)
Study contacts
- Study coordinator: Peiru Wang, PHD
- Email: wpeiru@qq.com
- Phone: 021-18017336579
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.