Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis

Actinic Keratosis Clinical Trial

Official title:

Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04396184
• Other study ID #: 2020-09
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2020
• Source: Shanghai Dermatology Hospital
• Contact: Yunfeng Zhang, MD
• Phone: 18217422425
• Email: yunfeng0519116[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#painless-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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Those who had ALA-PDT and any other studies that affect this study within 12 weeks ;

2. There are other facial diseases that may affect the efficacy evaluation, such as other photodermatosis;

3. Take phototoxic or photosensitizer within 8 weeks;

4. Clinical and / or pathological prove that the tumor has invaded other organs or tissues;

5. Serious immunocompromised persons;

6. scar constitution;

7. Patients are known to have skin photosensitivity, porphyria, or allergies to ALA, light or lidocaine;

8. Persons are suffering from severe internal diseases, mental and mental illness, infectious diseases or pregnant or lactating women.

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Procedure:
• Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy

Locations

Country	Name	City	State
China	Yunfeng Zhang	Shanghai	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain assessment	The pain will be assessed using Vissual Analogue Scale(VAS) with a score range of 0-10.The higher the score,the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment	Immediately, 1st minute, 3rd minute, 5th minute, 10th minute, 30th minute, 1hour ,2hour, 4hour, 12hour, 24hour,48hour ,72hour