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Trial record 15 of 24 for:    Porphyrins

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

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ClinicalTrials.gov Identifier: NCT03642535
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Huadong Hospital
Peking University First Hospital
The First Affiliated Hospital of Kunming Medical College
General Hospital of Ningxia Medical University
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Xiuli Wang, Shanghai Dermatology Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: ALA Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention: A Long-term (3 Years) Follow-up of Prospective, Randomized, Multicenter-clinical Trial
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALA for all face group
Scales and crusts were gently removed by curettage, and the lesions to be treated were scraped carefully to avoid bleeding. Immediately afterwards, a 1-mm thick layer of 10% ALA was applied to the all face. The area was covered with an occlusive dressing for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's lamp. Treatment area (all face)was then separately illuminated with red light-emitting diode lamps with peak emission at 630 nm and total light dose of 100 J/cm2. The treatment is once a week for total 3 times. The patients then follow up in clinic 3 years after their treatment to have the number of actinic keratoses counted.
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.
Other Name: Aminolevulinic Acid

Active Comparator: ALA for AK lesion group
Scales and crusts were gently removed by curettage, and the lesions to be treated were scraped carefully to avoid bleeding. Then a 1-mm thick layer of 10% ALA was applied to the lesion and 5 mm of surrounding healthy tissue. Vehicle control cream was applied to the non-lesion area. All area was covered with an occlusive dressing for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's lamp. Treatment area (all face)was then separately illuminated with red light-emitting diode lamps with peak emission at 630 nm and total light dose of 100 J/cm2. The treatment is once a week for total 3 times. The patients then follow up in clinic 3 years after their treatment to have the number of actinic keratoses counted.
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.
Other Name: Aminolevulinic Acid




Primary Outcome Measures :
  1. Number of new Actinic Keratoses [ Time Frame: 1, 3, 6, 9, 12, 18, 24, 30, 36 months after treatment ]
    The change in number of actinic keratoses at each follow-up will be measured as the primary outcome


Secondary Outcome Measures :
  1. The clearance rate of Actinic Keratoses [ Time Frame: 1 month after treatment ]
    The change rate in lesion clearance of Actinic Keratoses at one month after treatment will be measured as the second outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642535


Contacts
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Contact: Peiru Wang, PHD 021-18017336579 wpeiru@qq.com
Contact: Lude Zhu, MD 021-15821804557 zhulude0318@163.com

Locations
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China, Jingan
Shanghai Dermatology Hospital Recruiting
Shanghai, Jingan, China, 200443
Contact: Peiru Wang, PHD    021-18017336579    wpeiru@qq.com   
Contact: Lude Zhu, MD    021-15821804557    zhulude0318@163.com   
Principal Investigator: Xiuli Wang, PHD,MD         
Sub-Investigator: Peiru Wang, PHD         
Sub-Investigator: Hongwei Wang, PHD         
Sub-Investigator: Kun Chen, PHD, MD         
Sub-Investigator: Hang Li, PHD, MD         
Sub-Investigator: Xiaojing Kang, PHD, MD         
Sponsors and Collaborators
Shanghai Dermatology Hospital
Huadong Hospital
Peking University First Hospital
The First Affiliated Hospital of Kunming Medical College
General Hospital of Ningxia Medical University
Chinese Academy of Medical Sciences
Investigators
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Study Chair: Xiuli Wang, PHD, MD Shanghai Skin Disease Hospital

Publications of Results:

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Responsible Party: Xiuli Wang, Clinical Professor, Shanghai Dermatology Hospital
ClinicalTrials.gov Identifier: NCT03642535     History of Changes
Other Study ID Numbers: 2017-014
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: underlie results
Supporting Materials: Clinical Study Report (CSR)
Time Frame: One year after finishing this study and for permanency
Access Criteria: anyone who search pubmed
URL: http://www.ncbi.nlm.nih.gov/pubmed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiuli Wang, Shanghai Dermatology Hospital:
Photodynamic Therapy
Actinic Keratoses

Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents