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

Actinic Keratoses Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642535
• Other study ID #: 2017-014
• Status: Recruiting
• Phase: Phase 4
• Start date: August 30, 2018
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2019
• Source: Shanghai Dermatology Hospital
• Contact: Peiru Wang, PHD
• Phone: 021-18017336579
• Email: wpeiru[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• 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 Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Dermatology Hospital	Shanghai	Jingan

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital	Chinese Academy of Medical Sciences, General Hospital of Ningxia Medical University, Huadong Hospital, Peking University First Hospital, The First Affiliated Hospital of Kunming Medical College

Country where clinical trial is conducted

China, 

References & Publications (10)

Eibenschutz L, Silipo V, De Simone P, Buccini PL, Ferrari A, Carbone A, Catricalà 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 tr — View 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. d — View Citation

Neittaanmäki-Perttu N, Grönroos M, Tani T, Pölönen 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. — View 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 V — View Citation

Perl M, Goldenberg G. Field therapy in the treatment of actinic keratosis. Cutis. 2014 Apr;93(4):172-3. — View 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 — View Citation

Reinhold U, Dirschka T, Ostendorf R, Aschoff R, Berking C, Philipp-Dormston WG, Hahn S, Lau K, Jäger A, Schmitz B, Lübbert H, Szeimies RM. A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz(® — View 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. — View 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 — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 month after treatment