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

Primary Purpose

Actinic Keratoses

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

ALA

About this trial

This is an interventional prevention trial for Actinic Keratoses focused on measuring Photodynamic Therapy, Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Shanghai Dermatology HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALA for all face group

ALA for AK lesion group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of new Actinic Keratoses

The change in number of actinic keratoses at each follow-up will be measured as the primary outcome

Secondary Outcome Measures

The clearance rate of Actinic Keratoses

The change rate in lesion clearance of Actinic Keratoses at one month after treatment will be measured as the second outcome

Full Information

NCT ID

NCT03642535

First Posted

January 4, 2018

Last Updated

March 18, 2019

Sponsor

Shanghai Dermatology Hospital

Collaborators

Huadong Hospital, Peking University First Hospital, First Affiliated Hospital of Kunming Medical University, General Hospital of Ningxia Medical University, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03642535

Brief Title

Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Recruiting

Study Start Date

August 30, 2018 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Dermatology Hospital

Collaborators

Huadong Hospital, Peking University First Hospital, First Affiliated Hospital of Kunming Medical University, General Hospital of Ningxia Medical University, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratoses

Keywords

Photodynamic Therapy, Actinic Keratoses

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ALA for all face group

Arm Type

Experimental

Arm Description

Arm Title

ALA for AK lesion group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

ALA

Other Intervention Name(s)

Aminolevulinic Acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of new Actinic Keratoses

Description

The change in number of actinic keratoses at each follow-up will be measured as the primary outcome

Time Frame

1, 3, 6, 9, 12, 18, 24, 30, 36 months after treatment

Secondary Outcome Measure Information:

Title

The clearance rate of Actinic Keratoses

Description

The change rate in lesion clearance of Actinic Keratoses at one month after treatment will be measured as the second outcome

Time Frame

1 month after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peiru Wang, PHD

Phone

021-18017336579

wpeiru@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lude Zhu, MD

Phone

021-15821804557

zhulude0318@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, PHD, MD

Organizational Affiliation

Shanghai Skin Disease Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Dermatology Hospital

City

Shanghai

State/Province

Jingan

ZIP/Postal Code

200443

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peiru Wang, PHD

Phone

021-18017336579

wpeiru@qq.com

First Name & Middle Initial & Last Name & Degree

Lude Zhu, MD

Phone

021-15821804557

zhulude0318@163.com

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, PHD,MD

First Name & Middle Initial & Last Name & Degree

Peiru Wang, PHD

First Name & Middle Initial & Last Name & Degree

Hongwei Wang, PHD

First Name & Middle Initial & Last Name & Degree

Kun Chen, PHD, MD

First Name & Middle Initial & Last Name & Degree

Hang Li, PHD, MD

First Name & Middle Initial & Last Name & Degree

Xiaojing Kang, PHD, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

underlie results

IPD Sharing Time Frame

One year after finishing this study and for permanency

IPD Sharing Access Criteria

anyone who search pubmed

IPD Sharing URL

http://www.ncbi.nlm.nih.gov/pubmed

Citations:

PubMed Identifier

25950503

Citation

Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.

Results Reference

result

PubMed Identifier

28532759

Citation

Walker JL, Siegel JA, Sachar M, Pomerantz H, Chen SC, Swetter SM, Dellavalle RP, Stricklin GP, Qureshi AA, DiGiovanna JJ, Weinstock MA. 5-Fluorouracil for Actinic Keratosis Treatment and Chemoprevention: A Randomized Controlled Trial. J Invest Dermatol. 2017 Jun;137(6):1367-1370. doi: 10.1016/j.jid.2016.12.029. No abstract available.

Results Reference

result

PubMed Identifier

24818175

Citation

Perl M, Goldenberg G. Field therapy in the treatment of actinic keratosis. Cutis. 2014 Apr;93(4):172-3. No abstract available.

Results Reference

result

PubMed Identifier

24589500

Citation

Stockfleth E, Gupta G, Peris K, Aractingi S, Dakovic R, Alomar A. Reduction in lesions from Lmax: a new concept for assessing efficacy of field-directed therapy for actinic keratosis. Results with imiquimod 3.75%. Eur J Dermatol. 2014 Jan-Feb;24(1):23-7. doi: 10.1684/ejd.2014.2265.

Results Reference

result

PubMed Identifier

24037822

Citation

Neittaanmaki-Perttu N, Gronroos M, Tani T, Polonen I, Ranki A, Saksela O, Snellman E. Detecting field cancerization using a hyperspectral imaging system. Lasers Surg Med. 2013 Sep;45(7):410-7. doi: 10.1002/lsm.22160.

Results Reference

result

PubMed Identifier

25174261

Citation

Gupta G, Stockfleth E, Peris K, Aractingi S, Alomar A, Dakovic R, Dirschka T. Long-term sustained lesion clearance from Lmax with imiquimod 3.75%, a new field-directed treatment for actinic keratosis. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1840-2. doi: 10.1111/jdv.12697. Epub 2014 Aug 29.

Results Reference

result

PubMed Identifier

26300464

Citation

Pellacani G, Peris K, Guillen C, Clonier F, Larsson T, Venkata R, Puig S. A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2192-8. doi: 10.1111/jdv.13211. Epub 2015 Aug 24.

Results Reference

result

PubMed Identifier

26921093

Citation

Reinhold U, Dirschka T, Ostendorf R, Aschoff R, Berking C, Philipp-Dormston WG, Hahn S, Lau K, Jager A, Schmitz B, Lubbert H, Szeimies RM. A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz((R)) ) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED((R)) lamp. Br J Dermatol. 2016 Oct;175(4):696-705. doi: 10.1111/bjd.14498. Epub 2016 Jun 25.

Results Reference

result

PubMed Identifier

22329784

Citation

Szeimies RM, Torezan L, Niwa A, Valente N, Unger P, Kohl E, Schreml S, Babilas P, Karrer S, Festa-Neto C. Clinical, histopathological and immunohistochemical assessment of human skin field cancerization before and after photodynamic therapy. Br J Dermatol. 2012 Jul;167(1):150-9. doi: 10.1111/j.1365-2133.2012.10887.x. Epub 2012 Jun 1.

Results Reference

result

PubMed Identifier

27167413

Citation

Eibenschutz L, Silipo V, De Simone P, Buccini PL, Ferrari A, Carbone A, Catricala C. A 9-month, randomized, assessor-blinded, parallel-group study to evaluate clinical effects of film-forming medical devices containing photolyase and sun filters in the treatment of field cancerization compared with sunscreen in patients after successful photodynamic therapy for actinic keratosis. Br J Dermatol. 2016 Dec;175(6):1391-1393. doi: 10.1111/bjd.14721. Epub 2016 Oct 18. No abstract available.

Results Reference

result

Learn more about this trial

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

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