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Evaluation of the safety and efficacy of fluorescence diagnosis (PDD) combined with ALA photodynamic therapy (PDT) for treating field cancerization in actinic keratosis (AK)

Evaluation of the safety and efficacy of fluorescence diagnosis (PDD) combined with ALA photodynamic therapy (PDT) for treating field cancerization in actinic keratosis (AK)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092654
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-25
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

actinic keratosis

Interventions

ALA+PDD group:application of 20% ALA solution, and subsequent exposure to red light (635nm wavelength) with an energy density of 100-120J/cm2 for 30 minutes

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 50 and 75 years (inclusive), no restriction on gender. 2. Histopathologically confirmed cases of actinic keratosis (AK) on the head and face. 3. No cardiovascular or cerebrovascular disease, no liver or kidney dysfunction, and no neurological or sensory disorders. 4. Participants who agree to join this clinical trial and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Received local or systemic treatment for AK within the past 6 months. 2. Has severe cognitive, communicative, or mental disorders. 3. Allergic to ALA, other topical photosensitizers, or cream dressings. 4. History of photosensitivity disorders. 5. Presence of active infections, immune dysfunction, coagulation disorders, or malignancies. 6. Participation in any other research study within the past 30 days. 7. Deemed unsuitable for participation in this clinical trial for any other reasons determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Complete remission rate of AK lesions 3 months after the last therapy;

Secondary

MeasureTime frame
The recurrence rate of skin lesions at 6 months after the last treatment;The recurrence rate of skin lesions at 12 months after the last treatment;Partial remission rate of skin lesions in the third month after the last treatment;

Countries

China

Contacts

Public ContactXian Jiang

West China Hospital, Sichuan University

jennyxianj@163.com+86 189 8060 1693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026