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Efficacy and safety evaluation of painless photodynamic therapy for actinic keratosis: a randomized, open-label trial.

Efficacy and safety evaluation of painless photodynamic therapy for actinic keratosis: a randomized, ppen-label trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033064
Enrollment
Unknown
Registered
2020-05-19
Start date
2020-05-06
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Actinic keratoses

Interventions

experimental group:Painless photodynamic therapy
control group:Conventional photodynamic therapy

Sponsors

Shanghai Dermatology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

Exclusion criteria: 1. Those who have been treated with ALA-PDT and those who have applied any other impact study within 12 weeks; 2. Patients with other diseases that may affect the efficacy evaluation, such as other light skin diseases; 3. Patients taking phototoxic or photosensitive drugs within 8 weeks; 4. Patients with clinically and / or pathologically proven tumor invasion to other organs or tissues; 5. Patients with severe immune dysfunction; 6. Patients with scar constitution; 7. Patients with known skin photoallergy, porphyria or allergy to Ala, light or lidocaine; 8. Those who suffer from serious internal diseases, psychological and mental diseases, infectious diseases or pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
complete clearance rate of AK lesions at 1 month after PDT;

Secondary

MeasureTime frame
Pain assessment;Follow up the recurrence of AK lesions;

Countries

China

Contacts

Public ContactXiuli Wang

Shanghai Dermatology hospital

wangxiuli20150315@163.com+86 18017336663

Outcome results

None listed

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