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Climatotherapy Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis

Primary Purpose

Papulosquamous Skin Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical corticosteroids with salicylic acid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Papulosquamous Skin Disease

Eligibility Criteria

9 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Clinical diagnosis of psoriasis(mild to moderate) .
  2. Age 9-60 years

Exclusion Criteria:

1-Patients under 9 years. 2-Patient with severe psoriasis. 3-Skin cancer. 4-Renal insufficiency. 5-Acute infections. 6-Severe hypertension. 7-Skin and systemic diseases worsened by sun exposure. 8-Acute and non controlled concomitant diseases. 9-Ischemic heart diseases or any disease rendering them unable to bathe.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients with Good response to treatment
    Didital photography and histopathalogical examination

    Secondary Outcome Measures

    Full Information

    First Posted
    May 13, 2017
    Last Updated
    May 15, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03156062
    Brief Title
    Climatotherapy Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis
    Official Title
    Climatotherapy at Red Sea - Hurghada Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2017 (Anticipated)
    Primary Completion Date
    October 1, 2017 (Anticipated)
    Study Completion Date
    May 1, 2018 (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 multisystem disease predominately manifested as chronic inflammation of the skin and characterized by scaly, erythematous patches, papules and plaques, which are often pruritic. As chronic disease, psoriasis waxes and wanes throughout patient life time. The disease course is modified with initiation and cessation of treatment, and spontaneous remission is rare. Clinically lesions can be distributed in any part of the body, this leads to impaired consequences on the perception of body image, social relations and in general on quality of life.
    Detailed Description
    The severity of psoriasis is defined by the extent of body surface involvement as well as the involvement of areas that substantially affect daily life such as hands, feet, face and genital region . Approximately 80% of patients have mild to moderate disease and 20% have moderate to severe disease. Although the precise etiology of psoriasis remains unknown, a combination of immunologic, genetic and environmental factors contribute to its development and exacerbation. Psoriasis has multifactorial pathogenesis in which predisposing genetic factors (dysregulation of the immune system and alteration of keratinocytes) and environmental trigger factors (such as local trauma, streptococcal infections, emotional stress, drugs as B-blockers and lithium) interact with each other by triggering a specific immune response mediated by T-lymphocytes.Treatment of psoriasis is still very complex. Several treatments for plaque psoriasis are available as topical medications for mild to moderate cases of psoriasis (corticosteroids, vit D3 analogues, salicylic acid, dithranol etc.). Phototherapy is useful in moderately-severe psoriasis unresponsive to topical therapy alone. Systemic treatment is used for severe forms of psoriasis including immunosuppressive drugs such as methotrexate or cyclosporine, retinoids, etc., and in cases of contraindications or ineffectiveness of these drugs these severe forms of psoriasis can be treated with biological drugs such as adalimumab, etanercept, infliximab, etc.The climatotherapy presents a safe and efficient alternative to conventional therapeutic modality for psoriasis. Climatotherapy treatment is based on healing capacities of natural resources.Climatic treatment includes balneotherapy and sun exposure. Balneotherapy represents a set of methods and practices (bathing, drinking, inhalation, etc.)

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Topical corticosteroids with salicylic acid
    Intervention Description
    comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis
    Primary Outcome Measure Information:
    Title
    Number of patients with Good response to treatment
    Description
    Didital photography and histopathalogical examination
    Time Frame
    1day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of psoriasis(mild to moderate) . Age 9-60 years Exclusion Criteria: 1-Patients under 9 years. 2-Patient with severe psoriasis. 3-Skin cancer. 4-Renal insufficiency. 5-Acute infections. 6-Severe hypertension. 7-Skin and systemic diseases worsened by sun exposure. 8-Acute and non controlled concomitant diseases. 9-Ischemic heart diseases or any disease rendering them unable to bathe.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Kamal, MD
    Phone
    01005369338
    Email
    emohanya@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abd Al Majeed, MD
    Phone
    01001349280
    Email
    dr_ahmed1978@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18021886
    Citation
    Naldi L, Gambini D. The clinical spectrum of psoriasis. Clin Dermatol. 2007 Nov-Dec;25(6):510-8. doi: 10.1016/j.clindermatol.2007.08.003.
    Results Reference
    background
    PubMed Identifier
    21306785
    Citation
    American Academy of Dermatology Work Group; Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb A, Koo JY, Lebwohl M, Leonardi CL, Lim HW, Van Voorhees AS, Beutner KR, Ryan C, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74. doi: 10.1016/j.jaad.2010.11.055. Epub 2011 Feb 8.
    Results Reference
    background
    PubMed Identifier
    14996755
    Citation
    Bowcock AM, Cookson WO. The genetics of psoriasis, psoriatic arthritis and atopic dermatitis. Hum Mol Genet. 2004 Apr 1;13 Spec No 1:R43-55. doi: 10.1093/hmg/ddh094.
    Results Reference
    background
    PubMed Identifier
    21575063
    Citation
    Harari M, Czarnowicki T, Fluss R, Ruzicka T, Ingber A. Patients with early-onset psoriasis achieve better results following Dead Sea climatotherapy. J Eur Acad Dermatol Venereol. 2012 May;26(5):554-9. doi: 10.1111/j.1468-3083.2011.04099.x. Epub 2011 May 17.
    Results Reference
    background
    PubMed Identifier
    17910722
    Citation
    Harari M, Novack L, Barth J, David M, Friger M, Moses SW. The percentage of patients achieving PASI 75 after 1 month and remission time after climatotherapy at the Dead Sea. Int J Dermatol. 2007 Oct;46(10):1087-91. doi: 10.1111/j.1365-4632.2007.03278.x.
    Results Reference
    background
    PubMed Identifier
    8875954
    Citation
    Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996 Nov;107(5):707-13. doi: 10.1111/1523-1747.ep12365600.
    Results Reference
    background
    PubMed Identifier
    357213
    Citation
    Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
    Results Reference
    background
    PubMed Identifier
    15109271
    Citation
    Guenther LC. Fixed-dose combination therapy for psoriasis. Am J Clin Dermatol. 2004;5(2):71-7. doi: 10.2165/00128071-200405020-00001. Erratum In: Am J Clin Dermatol. 2004;5(4):279.
    Results Reference
    background
    PubMed Identifier
    18423261
    Citation
    Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64. doi: 10.1016/j.jaad.2008.02.040.
    Results Reference
    background

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    Climatotherapy Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis

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