NCT04396184

Brief Summary

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA-PDT) to a conventional regimen for treatment of Actinic Keratosis. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 17, 2020

Last Update Submit

May 17, 2020

Conditions

Actinic Keratosis

Keywords

Photodynamic TherapyConventionalPainlessActinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • The clearance rate of Actinic Keratoses

    The change rate in lesion clearance of Actinic Keratoses at six weeks after treatment will be measured as the primary outcome

    six weeks after treatment

Secondary Outcomes (1)

  • Pain assessment

    Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour

Study Arms (2)

Painless Photodynamic Therapy(P-PDT) group

EXPERIMENTAL

The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 288 J/cm2) after applying 5% 5-aminolevulinic acid#ALA#cream for 30min. A repeat treatment was administered once every two weeks for 3 times.

Procedure: Aminolevulinic acid photodynamic therapy

Conventional Photodynamic Therapy(C-PDT) group

ACTIVE COMPARATOR

The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times.

Procedure: Aminolevulinic acid photodynamic therapy

Interventions

Aminolevulinic acid photodynamic therapyPROCEDURE

Aminolevulinic acid photodynamic therapy

Conventional Photodynamic Therapy(C-PDT) groupPainless Photodynamic Therapy(P-PDT) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • 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.

You may not qualify if:

  • Those who had ALA-PDT and any other studies that affect this study within 12 weeks ;
  • There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis;
  • Take phototoxic or photosensitizer within 8 weeks;
  • Clinical and / or pathological prove that the tumor has invaded other organs or tissues;
  • Serious immunocompromised persons;
  • scar constitution;
  • Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine;
  • Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunfeng Zhang

Shanghai, Jinan, 200443, China

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xiuli Wang, PHD,MD

    Shanghai Skin Disease Hospital

    STUDY CHAIR

Central Study Contacts

Yunfeng Zhang, MD

CONTACT

18217422425yunfeng0519116@aliyun.com

Haiyan Zhang, MD

CONTACT

18017336573zhanghaiyan10842@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator assesses photographs without prior knowledge of intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Professor

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 20, 2020

Study Start

May 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

underlie results

Shared Documents
CSR
Time Frame
One year after finishing this srudy and for permanency
Access Criteria
anyone who search pubmed

Locations

CN(1)