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
About this trial
This is an interventional diagnostic trial for Papulosquamous Skin Disease
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.
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
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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