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Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention

NCT03642535 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-03-19

No results posted yet for this study

Summary

Background Actinic keratoses (AKs) are often treated separately, lesion by lesion. However, in the past years, AKs have been described as a field disease and not limited to single clinically apparent lesions. Treatment should therefore target an area of field change which may treat the subclinical AKs and reduce the risk of development of further AKs, second tumours, and local recurrence.

Objectives The investigators sought to investigate whether field ALA-PDT of facial actinic keratosis would prevent new AKs, in comparison with a lesion area receiving the same ALA-PDT, in patients with clinical signs of field cancerization.

Methods Eighty patients, previously diagnosed as having AKs of the face, were randomized distribution into two groups. 10% aminolaevulinic acid (ALA)-PDT for field treatment was on one group and for a lesion area (Vehicle control cream was applied to the non-lesion area) was on the other group. During the next 5-year period of follow up, patients were clinically evaluated for new AKs.

Conditions

  • Actinic Keratoses

Interventions

DRUG

ALA

In all face treatment group, a 1-mm thick layer of 10% ALA was applied to the all face; In AK lesion treatment group, a 1-mm thick layer of 10% ALA was applied to the lesion and to 5 mm of surrounding healthy tissue. And Vehicle control cream was applied to the non-lesion area.

Sponsors & Collaborators

  • Huadong Hospital

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • General Hospital of Ningxia Medical University

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Shanghai Dermatology Hospital

    lead OTHER

Principal Investigators

  • Xiuli Wang, PHD, MD · Shanghai Skin Disease Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642535 on ClinicalTrials.gov