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Excimer Laser With Topical Agents in Psoriasis Vulgaris

Primary Purpose

Psoriasis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
308nm Excimer laser
Tazarotene Topical Gel
Betamethasone Valerate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: ≥18 years.
  2. Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

Exclusion Criteria:

  1. History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks.
  2. Allergy to any ingredients of tretinoin or betamethasone drugs.
  3. Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness.
  4. Pregnancy, breast-feeding or women planning to become pregnant within 3 months.
  5. Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.
  6. Patients with other diseases and requiring treatment that would affect the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    group of patients with psoriasis vulgaris

    Arm Description

    in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*). Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1%

    Outcomes

    Primary Outcome Measures

    detection of improvement of psoriasis
    detection of improvement of psoriasis in response to excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment

    Secondary Outcome Measures

    dermoscopic role
    detection the role of the dermoscope in monitoring the response to treatment of psoriasis by excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment.

    Full Information

    First Posted
    September 17, 2022
    Last Updated
    October 15, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05555797
    Brief Title
    Excimer Laser With Topical Agents in Psoriasis Vulgaris
    Official Title
    Efficacy of Excimer Laser Combined With Either Topical Tazarotene or Topical Betamethasone Valerate Versus Excimer Laser Alone in Treatment of Localized Chronic Plaque Psoriasis; Clinical and Dermoscopic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors.
    Detailed Description
    Psoriasis presents as well-circumscribed, erythematous plaques with an overlying silvery white scales. It has an effect on various aspects of life including mental health, productivity and relationships. Topical therapies as corticosteroids and vitamin D3 analogs are first-line treatments for mild plaque psoriasis; which involves less than 3% of the body surface area (BSA). Moderate-to-severe plaque psoriasis is usually managed with phototherapy, systemic or biologic therapies . The American Academy of Dermatology gives a strength recommendation for the use of combination therapies for treatment of psoriasis with superior efficacy to monotherapy . The 308-nm excimer laser has been widely used for many dermatological diseases. In psoriasis, it shows an efficacy in the treatment of localised plaques especially on the knees and elbows. It is indicated in moderate to severe psoriasis that affects <10% of the body surface. Areas such as nose, ears and palpebral region can be easily accessed using the laser. It induces lymphocytic apoptosis and decreases the proliferation rate of keratinocytes . There are multiple protocols that evaluate the clinical response to Excimer laser; the induration protocol, the minimal erythema dose and the minimal blistering dose. The induration protocol compared with the others, allows to modify the dose with treatment. With this protocol, plaques achieved Psoriasis area and severity index (PASI-75) after 10 treatments . Tazarotene (TAZ) is a topical retinoid with retinoic acid receptor β / γ receptor specificity. It has been shown to be effective for psoriasis treatment. However, its topical application is limited by its irritation. Studies have shown that combination with other lines may optimize the efficacy as well as minimize the local irritation due to TAZ. Betamethasone valerate (BV) is a high-potency, synthetic corticosteroid which acts on the intracellular glucocorticoid receptor. It also binds to membrane-bound receptors, enhancing its action. BV suppresses the production of inflammatory cytokines and reduces keratinocyte hyperproliferation.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group of patients with psoriasis vulgaris
    Arm Type
    Experimental
    Arm Description
    in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*). Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1%
    Intervention Type
    Device
    Intervention Name(s)
    308nm Excimer laser
    Intervention Description
    Excimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol)
    Intervention Type
    Drug
    Intervention Name(s)
    Tazarotene Topical Gel
    Intervention Description
    Tazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Betamethasone Valerate
    Intervention Description
    .Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks.
    Primary Outcome Measure Information:
    Title
    detection of improvement of psoriasis
    Description
    detection of improvement of psoriasis in response to excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    dermoscopic role
    Description
    detection the role of the dermoscope in monitoring the response to treatment of psoriasis by excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: ≥18 years. Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area. Exclusion Criteria: History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks. Allergy to any ingredients of tretinoin or betamethasone drugs. Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness. Pregnancy, breast-feeding or women planning to become pregnant within 3 months. Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment. Patients with other diseases and requiring treatment that would affect the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doaa S Sayed, professor
    Phone
    01143387171
    Email
    doaasamir1@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman F Ahmed, Doctor
    Phone
    01002258614
    Email
    emanfathey639@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29387603
    Citation
    Abrouk M, Levin E, Brodsky M, Gandy JR, Nakamura M, Zhu TH, Farahnik B, Koo J, Bhutani T. Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability. Psoriasis (Auckl). 2016 Dec 12;6:165-173. doi: 10.2147/PTT.S105047. eCollection 2016.
    Results Reference
    result
    PubMed Identifier
    32508993
    Citation
    Ardeleanu V, Sabina Radaschin D, Tatu AL. Excimer laser for psoriasis treatment: A case report and short review. Exp Ther Med. 2020 Jul;20(1):52-55. doi: 10.3892/etm.2020.8529. Epub 2020 Feb 14.
    Results Reference
    result
    PubMed Identifier
    33352561
    Citation
    He C, Jin H, Liu X, Hu F, Zhang L, Zhang S, He Y, Yang X, Chen H, Wang X, Ji C, Lv C, Miao G, Li X, Diao Q, Li L, Li X, Li Y, Wang R, Zhang L, Zhou X, Xia X, Yan M, Song J, Zhang R, Geng L, Zheng M, Lu Q, Lu T, Shi Y, Jing H, Zhang X, Shi J, Xia J, Gao Y, Wang Y. Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study. Dermatology. 2021;237(4):603-610. doi: 10.1159/000511891. Epub 2020 Dec 22.
    Results Reference
    result
    PubMed Identifier
    32738429
    Citation
    Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, Kivelevitch D, Armstrong AW, Connor C, Cordoro KM, Davis DMR, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kaplan DH, Kavanaugh A, Kiselica M, Kroshinsky D, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Paller AS, Parra SL, Pathy AL, Siegel M, Stoff B, Strober B, Wu JJ, Hariharan V, Menter A. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021 Feb;84(2):432-470. doi: 10.1016/j.jaad.2020.07.087. Epub 2020 Jul 30.
    Results Reference
    result
    PubMed Identifier
    32129962
    Citation
    Nestor MS, Fischer D, Arnold D. Randomized, Investigator-Blinded Study to Compare the Efficacy and Tolerance of a 650-microsecond, 1064-nm YAG Laser to a 308-nm Excimer Laser for the Treatment of Mild to Moderate Psoriasis Vulgaris. J Drugs Dermatol. 2020 Feb 1;19(2):176-183. doi: 10.36849/JDD.2020.4769.
    Results Reference
    result
    PubMed Identifier
    15389191
    Citation
    Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician's Global Assessment. J Am Acad Dermatol. 2004 Oct;51(4):563-9. doi: 10.1016/j.jaad.2004.04.012.
    Results Reference
    result
    PubMed Identifier
    29448838
    Citation
    Ramez SA, Soliman MM, Fadel M, Nour El-Deen F, Nasr M, Youness ER, Aboel-Fadl DM. Novel methotrexate soft nanocarrier/fractional erbium YAG laser combination for clinical treatment of plaque psoriasis. Artif Cells Nanomed Biotechnol. 2018;46(sup1):996-1002. doi: 10.1080/21691401.2018.1440236. Epub 2018 Feb 15.
    Results Reference
    result
    PubMed Identifier
    12810507
    Citation
    Taneja A, Trehan M, Taylor CR. 308-nm excimer laser for the treatment of psoriasis: induration-based dosimetry. Arch Dermatol. 2003 Jun;139(6):759-64. doi: 10.1001/archderm.139.6.759.
    Results Reference
    result
    PubMed Identifier
    21284407
    Citation
    Naldi L, Yawalkar N, Kaszuba A, Ortonne JP, Morelli P, Rovati S, Mautone G. Efficacy and safety of the Betamethasone valerate 0.1% plaster in mild-to-moderate chronic plaque psoriasis: a randomized, parallel-group, active-controlled, phase III study. Am J Clin Dermatol. 2011 Jun 1;12(3):191-201. doi: 10.2165/11539780-000000000-00000.
    Results Reference
    result

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    Excimer Laser With Topical Agents in Psoriasis Vulgaris

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