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

NCT03642535 | Unknown Phase 4 DMC

• 1 other identifier: 2017-014
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Keywords

Photodynamic Therapy; Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Number of new Actinic Keratoses

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

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

Secondary Outcomes (1)

• The clearance rate of Actinic Keratoses

  1 month after treatment

Study Arms (2)

ALA for all face group

EXPERIMENTAL

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

ALA for AK lesion group

ACTIVE COMPARATOR

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

Interventions

ALA DRUG

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.

Also known as: Aminolevulinic Acid

ALA for AK lesion group; ALA for all face group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Shanghai Dermatology Hospital: lead
• Huadong Hospital: collaborator
• Peking University First Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Shanghai Dermatology Hospital

Shanghai, Jingan, 200443, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 25950503 RESULT

• 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.

  PMID: 28532759 RESULT

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

  PMID: 24818175 RESULT

• 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.

  PMID: 24589500 RESULT

• 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.

  PMID: 24037822 RESULT

• 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.

  PMID: 25174261 RESULT

• 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.

  PMID: 26300464 RESULT

• 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.

  PMID: 26921093 RESULT

• 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.

  PMID: 22329784 RESULT

• 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.

  PMID: 27167413 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Xiuli Wang, PHD, MD

  Shanghai Skin Disease Hospital

  STUDY CHAIR

Central Study Contacts

Peiru Wang, PHD

CONTACT

021-18017336579; wpeiru@qq.com

Lude Zhu, MD

CONTACT

021-15821804557; zhulude0318@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: August 22, 2018
• Study Start: August 30, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: One year after finishing this study and for permanency
• Access Criteria: anyone who search pubmed

Locations

CN (1)