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Efficacy and safety evaluation of the combination of microneedles or ultra-pulse CO2 fractional laser preconditioning and ALA-PDT for actinic keratosis

Efficacy and safety evaluation of the combination of microneedles or ultra-pulse CO2 fractional laser preconditioning and ALA-PDT for actinic keratosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045487
Enrollment
Unknown
Registered
2021-04-17
Start date
2021-04-15
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Actinic keratoses

Interventions

control group:Conventional treatment
experimental group A:Microneedles + ALA-PDT
experimental group B:Ultra-pulse CO2 fractional laser + ALA-PDT

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosed with AK (OLSEN classification grade I, II, III), histopathologic findings were consistent with actinic keratosis, aged > 18 years; 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. Patients 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 12 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;

Secondary

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

Countries

China

Contacts

Public ContactJiang Guan

The Affiliated Hospital of Xuzhou Medical University

dr.guanjiang@xzhmu.edu.cn+86 18052268168

Outcome results

None listed

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