• Login
    View Item 
    •   Home
    • UA Faculty Research
    • UA Faculty Publications
    • View Item
    •   Home
    • UA Faculty Research
    • UA Faculty Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of UA Campus RepositoryCommunitiesTitleAuthorsIssue DateSubmit DateSubjectsPublisherJournalThis CollectionTitleAuthorsIssue DateSubmit DateSubjectsPublisherJournal

    My Account

    LoginRegister

    About

    AboutUA Faculty PublicationsUA DissertationsUA Master's ThesesUA Honors ThesesUA PressUA YearbooksUA CatalogsUA Libraries

    Statistics

    Most Popular ItemsStatistics by CountryMost Popular Authors

    Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    jamadermatology_kim_2022_oi_22 ...
    Embargo:
    2023-07-20
    Size:
    358.6Kb
    Format:
    PDF
    Description:
    Final Published Version
    Download
    Author
    Kim, E.J.
    Mangold, A.R.
    Desimone, J.A.
    Wong, H.K.
    Seminario-Vidal, L.
    Guitart, J.
    Appel, J.
    Geskin, L.
    Lain, E.
    Korman, N.J.
    Zeitouni, N.
    Nikbakht, N.
    Dawes, K.
    Akilov, O.
    Carter, J.
    Shinohara, M.
    Kuzel, T.M.
    Piette, W.
    Bhatia, N.
    Musiek, A.
    Pariser, D.
    Kim, Y.H.
    Elston, D.
    Boh, E.
    Duvic, M.
    Huen, A.
    Pacheco, T.
    Zwerner, J.P.
    Lee, S.T.
    Girardi, M.
    Querfeld, C.
    Bohjanen, K.
    Olsen, E.
    Wood, G.S.
    Rumage, A.
    Donini, O.
    Haulenbeek, A.
    Schaber, C.J.
    Straube, R.
    Pullion, C.
    Rook, A.H.
    Poligone, B.
    Show allShow less
    Issue Date
    2022
    
    Metadata
    Show full item record
    Publisher
    American Medical Association
    Citation
    Kim, E. J., Mangold, A. R., Desimone, J. A., Wong, H. K., Seminario-Vidal, L., Guitart, J., Appel, J., Geskin, L., Lain, E., Korman, N. J., Zeitouni, N., Nikbakht, N., Dawes, K., Akilov, O., Carter, J., Shinohara, M., Kuzel, T. M., Piette, W., Bhatia, N., … Poligone, B. (2022). Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatology.
    Journal
    JAMA Dermatology
    Rights
    Copyright © 2022 American Medical Association. All rights reserved.
    Collection Information
    This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.
    Abstract
    Importance: Given that mycosis fungoides-cutaneous T-cell lymphoma (MF/CTCL) is chronic, there is a need for additional therapies with minimal short- and long-term adverse effects. Topical synthetic hypericin ointment, 0.25%, activated with visible light is a novel, nonmutagenic photodynamic therapy (PDT). Objectives: To determine the efficacy and safety of topical synthetic hypericin ointment, 0.25%, activated with visible light as a nonmutagenic PDT in early-stage MF/CTCL. Design, Settings, and Participants: This was a multicenter, placebo-controlled, double-blinded, phase 3 randomized clinical trial (FLASH study) conducted from December 2015 to November 2020 at 39 academic and community-based US medical centers. Participants were adults (≥18 years) with early-stage (IA-IIA) MF/CTCL. Interventions: In cycle 1, patients were randomized 2:1 to receive hypericin or placebo to 3 index lesions twice weekly for 6 weeks. In cycle 2, all patients received the active drug for 6 weeks to index lesions. In cycle 3 (optional), both index and additional lesions received active drug for 6 weeks. Main Outcomes and Measures: The primary end point was index lesion response rate (ILRR), defined as 50% or greater improvement in modified Composite Assessment of Index Lesion Severity (mCAILS) score from baseline after 6 weeks of therapy for cycle 1. For cycles 2 and 3, open label response rates were secondary end points. Adverse events (AEs) were assessed at each treatment visit, after each cycle, and then monthly for 6 months. Data analyses were performed on December 21, 2020. Results: The study population comprised 169 patients (mean [SD] age, 58.4 [16.0] years; 96 [57.8%] men; 120 [72.3%] White individuals) with early-stage MF/CTCL. After 6 weeks of treatment, hypericin PDT was more effective than placebo (cycle 1 ILRR, 16% vs 4%; P =.04). The ILRR increased to 40% in patients who received 2 cycles of hypericin PDT (P <.001 vs cycle 1 hypericin) and to 49% after 3 cycles (P <.001 vs cycle 1 hypericin). Significant clinical responses were observed in both patch and plaque type lesions and were similar regardless of age, sex, race, stage IA vs IB, time since diagnosis, and number of prior therapies. The most common treatment-related AEs were mild local skin (13.5%-17.3% across cycles 1-3 vs 10.5% for placebo in cycle 1) and application-site reactions (3.2%-6.9% across cycles 1-3 vs 4% for placebo in cycle 1). No drug-related serious AEs occurred. Conclusion and Relevance: The findings of this randomized clinical trial indicate that synthetic hypericin PDT is effective in early-stage patch and plaque MF/CTCL and has a favorable safety profile. Trial Registration: ClinicalTrials.gov Identifier: NCT02448381. © 2022 American Medical Association. All rights reserved.
    Note
    12 month embargo; published online: 20 July 2022
    ISSN
    2168-6068
    PubMed ID
    35857290
    DOI
    10.1001/jamadermatol.2022.2749
    Version
    Final published version
    ae974a485f413a2113503eed53cd6c53
    10.1001/jamadermatol.2022.2749
    Scopus Count
    Collections
    UA Faculty Publications

    entitlement

    Related articles

    • Interventions for mycosis fungoides.
    • Authors: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T
    • Issue date: 2020 Jul 7
    • Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides.
    • Authors: Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH
    • Issue date: 2013 Jan
    • Evaluation of O6-Benzylguanine-Potentiated Topical Carmustine for Mycosis Fungoides: A Phase 1-2 Clinical Trial.
    • Authors: Tacastacas JD, Chan DV, Carlson S, Gerson SL, Dowlati A, Fu P, Lu K, Groft S, Rosenjack J, Honda K, McCormick TS, Cooper KD
    • Issue date: 2017 May 1
    • Interventions for mycosis fungoides.
    • Authors: Weberschock T, Strametz R, Lorenz M, Röllig C, Bunch C, Bauer A, Schmitt J
    • Issue date: 2012 Sep 12
    • Photodynamic therapy of cutaneous lymphoma using 5-aminolevulinic acid topical application.
    • Authors: Orenstein A, Haik J, Tamir J, Winkler E, Trau H, Malik Z, Kostenich G
    • Issue date: 2000 Aug
    The University of Arizona Libraries | 1510 E. University Blvd. | Tucson, AZ 85721-0055
    Tel 520-621-6442 | repository@u.library.arizona.edu
    DSpace software copyright © 2002-2017  DuraSpace
    Quick Guide | Contact Us | Send Feedback
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.