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

NCT ID: NCT03156062

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-05-01

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.)

Conditions

Papulosquamous Skin Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

study group

Group Type: EXPERIMENTAL

Topical corticosteroids with salicylic acid

Intervention Type: DRUG

comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis

control group

Group Type: ACTIVE_COMPARATOR

Topical corticosteroids with salicylic acid

Intervention Type: DRUG

comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis

Interventions

Topical corticosteroids with salicylic acid

comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

ESAhmed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eman Kamal, MD

Role: CONTACT

emohanya@yahoo.com

01005369338

Ahmed Abd Al Majeed, MD

Role: CONTACT

dr_ahmed1978@yahoo.com

01001349280

References

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Reference Type: BACKGROUND

PMID: 18021886 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 14996755 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21575063 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 357213 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15109271 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18423261 (View on PubMed)

Other Identifiers

CCS

Identifier Type: -

Identifier Source: org_study_id