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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03156062
Recruitment Status : Unknown
Verified May 2017 by ESAhmed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
ESAhmed, Assiut University

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.

Condition or disease Intervention/treatment Phase
Papulosquamous Skin Disease Drug: Topical corticosteroids with salicylic acid Not Applicable

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.)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Climatotherapy at Red Sea - Hurghada Versus Topical Combination of Corticosteroids and Salicylic Acid in Treatment of Psoriasis
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Steroids

Arm Intervention/treatment
Experimental: study group Drug: Topical corticosteroids with salicylic acid
comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis

Active Comparator: control group Drug: Topical corticosteroids with salicylic acid
comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis




Primary Outcome Measures :
  1. Number of patients with Good response to treatment [ Time Frame: 1day ]
    Didital photography and histopathalogical examination



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156062


Contacts
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Contact: Eman Kamal, MD 01005369338 emohanya@yahoo.com
Contact: Ahmed Abd Al Majeed, MD 01001349280 dr_ahmed1978@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: ESAhmed, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03156062    
Other Study ID Numbers: CCS
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Salicylic Acid
Salicylates
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action