Comparison Between 5-aminolevulinic Acid Photodynamic Therapy Versus Cryotherapy for Actinic Keratosis Treatment

NCT01459393 | Completed Phase 3 DMC

• 1 other identifier: 5-ALAAK
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare in a prospective and randomized way actinic keratosis treatment with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of therapeutic efficacy, pain, and cosmetic results.

Conditions

Actinic Keratosis

Keywords

Actinic keratosis; Photodynamic therapy; 5-aminolevulinic acid; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Complete response rates

  Clinical evaluation of treated area.

  0 months (baseline), 3 months and 6 months

Secondary Outcomes (2)

• Visual Analogic Scale Pain Score

  0 months (baseline), 3 months, 6 months

• Cosmesis analysis

  3 months, 6 months

Study Arms (2)

5-ALA Photodynamic Therapy

EXPERIMENTAL

Topical application of a 2mm of thickness layer of 20% 5-aminolevulinic acid (5-ALA) associated with 20% dimethyl sulfoxide (DMSO) and 3% ethylene diamine acid (EDTA) emulsion, over the actinic keratosis lesion and over a 0,5 cm margin around it. After a 4 hours interval under light protection with plastic film and aluminum foil, the light protection and the emulsion is removed. Then the lesion is lightened with a red (630 nm) incoherent LED lamp AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway) with a total light dose of 37J/cm2.After that dressings are done and kept for 24H, and removed at patient home.

Drug: 5-ALA Photodynamic Therapy

Cryotherapy with liquid nitrogen

ACTIVE COMPARATOR

Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.

Drug: Cryotherapy with liquid nitrogen

Interventions

5-ALA Photodynamic Therapy DRUG

Also known as: AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway)

5-ALA Photodynamic Therapy

Cryotherapy with liquid nitrogen DRUG

Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.

Also known as: Cry-ac ®

Cryotherapy with liquid nitrogen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Patients with actinic keratoses "symmetrical", ie, comparable in the upper limbs ( with the same grade, I, II or III).
• Patients in accordance with informed consent.

You may not qualify if:

• Patients with concomitant skin diseases, congenital or acquired (albinism, vitiligo, xeroderma, Gorlin, etc.)
• Immunosuppression (HIV, transplanted patients, etc.)
• Pregnancy or lactation
• Patients who do not agree with the informed consent initially or during the protocol.
• Presence of pigmented lesions near the keratoses.
• Patients with porphyria.
• Patients who have undergone less than 2 months with some kind of treatment for keratosis in the upper limbs.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14.784 - 400, Brazil

Location

Related Publications (17)

• Braathen LR, Szeimies RM, Basset-Seguin N, Bissonnette R, Foley P, Pariser D, Roelandts R, Wennberg AM, Morton CA; International Society for Photodynamic Therapy in Dermatology. Guidelines on the use of photodynamic therapy for nonmelanoma skin cancer: an international consensus. International Society for Photodynamic Therapy in Dermatology, 2005. J Am Acad Dermatol. 2007 Jan;56(1):125-43. doi: 10.1016/j.jaad.2006.06.006.

  PMID: 17190630 BACKGROUND

• De Rosa FS, Bentley MV. Photodynamic therapy of skin cancers: sensitizers, clinical studies and future directives. Pharm Res. 2000 Dec;17(12):1447-55. doi: 10.1023/a:1007612905378.

  PMID: 11303952 BACKGROUND

• Dougherty TJ. A brief history of clinical photodynamic therapy development at Roswell Park Cancer Institute. J Clin Laser Med Surg. 1996 Oct;14(5):219-21. doi: 10.1089/clm.1996.14.219. No abstract available.

  PMID: 9612186 BACKGROUND

• Fink-Puches R, Hofer A, Smolle J, Kerl H, Wolf P. Primary clinical response and long-term follow-up of solar keratoses treated with topically applied 5-aminolevulinic acid and irradiation by different wave bands of light. J Photochem Photobiol B. 1997 Nov;41(1-2):145-51. doi: 10.1016/s1011-1344(97)00096-1.

  PMID: 9440322 BACKGROUND

• Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

  PMID: 3377516 BACKGROUND

• Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118.

  PMID: 12775317 BACKGROUND

• Glogau RG. The risk of progression to invasive disease. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):23-4. doi: 10.1067/mjd.2000.103339.

  PMID: 10607353 BACKGROUND

• Jeffes EW, McCullough JL, Weinstein GD, Fergin PE, Nelson JS, Shull TF, Simpson KR, Bukaty LM, Hoffman WL, Fong NL. Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. A pilot dose-ranging study. Arch Dermatol. 1997 Jun;133(6):727-32.

  PMID: 9197826 BACKGROUND

• Kaufmann R, Spelman L, Weightman W, Reifenberger J, Szeimies RM, Verhaeghe E, Kerrouche N, Sorba V, Villemagne H, Rhodes LE. Multicentre intraindividual randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities. Br J Dermatol. 2008 May;158(5):994-9. doi: 10.1111/j.1365-2133.2008.08488.x. Epub 2008 Mar 13.

  PMID: 18341663 BACKGROUND

• Kennedy JC, Pottier RH. Endogenous protoporphyrin IX, a clinically useful photosensitizer for photodynamic therapy. J Photochem Photobiol B. 1992 Jul 30;14(4):275-92. doi: 10.1016/1011-1344(92)85108-7.

  PMID: 1403373 BACKGROUND

• Malik Z, Kostenich G, Roitman L, Ehrenberg B, Orenstein A. Topical application of 5-aminolevulinic acid, DMSO and EDTA: protoporphyrin IX accumulation in skin and tumours of mice. J Photochem Photobiol B. 1995 Jun;28(3):213-8. doi: 10.1016/1011-1344(95)07117-k.

  PMID: 7623186 BACKGROUND

• Moloney FJ, Collins P. Randomized, double-blind, prospective study to compare topical 5-aminolaevulinic acid methylester with topical 5-aminolaevulinic acid photodynamic therapy for extensive scalp actinic keratosis. Br J Dermatol. 2007 Jul;157(1):87-91. doi: 10.1111/j.1365-2133.2007.07946.x. Epub 2007 May 14.

  PMID: 17501954 BACKGROUND

• Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):4-7. doi: 10.1067/mjd.2000.103342.

  PMID: 10607349 BACKGROUND

• Sotiriou E, Apalla Z, Maliamani F, Zaparas N, Panagiotidou D, Ioannides D. Intraindividual, right-left comparison of topical 5-aminolevulinic acid photodynamic therapy vs. 5% imiquimod cream for actinic keratoses on the upper extremities. J Eur Acad Dermatol Venereol. 2009 Sep;23(9):1061-5. doi: 10.1111/j.1468-3083.2009.03259.x. Epub 2009 Apr 8.

  PMID: 19470041 BACKGROUND

• Szeimies RM, Karrer S, Radakovic-Fijan S, Tanew A, Calzavara-Pinton PG, Zane C, Sidoroff A, Hempel M, Ulrich J, Proebstle T, Meffert H, Mulder M, Salomon D, Dittmar HC, Bauer JW, Kernland K, Braathen L. Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: A prospective, randomized study. J Am Acad Dermatol. 2002 Aug;47(2):258-62.

  PMID: 12140473 BACKGROUND

• Tschen EH, Wong DS, Pariser DM, Dunlap FE, Houlihan A, Ferdon MB; Phase IV ALA-PDT Actinic Keratosis Study Group. Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J Dermatol. 2006 Dec;155(6):1262-9. doi: 10.1111/j.1365-2133.2006.07520.x.

  PMID: 17107399 BACKGROUND

• Yantsos VA, Conrad N, Zabawski E, Cockerell CJ. Incipient intraepidermal cutaneous squamous cell carcinoma: a proposal for reclassifying and grading solar (actinic) keratoses. Semin Cutan Med Surg. 1999 Mar;18(1):3-14. doi: 10.1016/s1085-5629(99)80003-0.

  PMID: 10188837 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Catarina Robert, MD

  Fundação Pio XII - Hospital de Câncer de Barretos

  PRINCIPAL INVESTIGATOR

• René AC Vieira, PHD

  Fundação Pio XII - Hospital de Câncer de Barretos

  STUDY DIRECTOR

• André L Carvalho, PHD

  Fundação Pio XII - Hospital de Câncer de Barretos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 25, 2011
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 28, 2017

Record last verified: 2014-02

Locations

BR (1)