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Comparison of Efficacy of Intralesional Triamcinolone Injection and Clobetasol Propionate Ointment for Psoriatic Nails

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Nails

Intervention: 0.1% triamcinolone , 0.05% clobetasol propionate ointment (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Chanisada Wongpraparut, M.D., Principal Investigator, Affiliation: Faculty of Medicine Siriraj Hospital

Summary

Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of psoriatic nails is using topical high- potent steroids however topical steroids are limited their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of such a treatment can lead to skin atrophy and report in the case of "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory results without any serious permanent adverse effects. At present, there is no comparison study between intralesional steroid and ultrapotent topical steroid for the treatment of psoriatic nails. The purpose of the study is to evaluate the efficacy and safety of intralesional triamcinolone comparing to 0. 05% clobetasol ointment in the treatment of psoriatic nails.

Clinical Details

Official title: Comparison of Efficacy and Safety of Psoriatic Nails Treatment Between by Intralesional 0.1%Triamcinolone Injection and Topical 0.05%Clobetasol Propionate Ointment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent change in the NAPSI (Nail Psoriasis Severit Index) score of psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment

Secondary outcome: adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment

Detailed description: Psoriasis is a chronic inflammatory disorder. The nails involvement has been reported up to 40% of psoriatic patients. Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of psoriatic nails is using topical high- potent steroids however topical steroids are limited their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of such a treatment can lead to skin atrophy and report in the case of "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory results without any serious permanent adverse effects. At present, there is no comparison study between intralesional steroid and ultrapotent topical steroid for the treatment of psoriatic nails. The purpose of the study is to evaluate the efficacy and safety of intralesional triamcinolone comparing to 0. 05% clobetasol ointment in the treatment of psoriatic nails.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects aged over 18 years old who have at least 3 psoriatic finger nails resembly

severity Exclusion Criteria: 1. Patients are receiving the systemic therapy of psoriasis 2. Patients discontinued the systemic therapy less than 3 months and topical therapy less than 1 month 3. Positive results for the microscopic study of fungus in finger nails 4. History of steroids or EMLA allergy 5. Pregnancy or nursing 6. Any skin infection at the site of the treatment 7. Human immunodeficiency virus subjects 8. History of malignancy or during the treatment of malignancy 9. Patients who have psychological disorder 10. Patients who have bleeding disorder or receiving anticoagulation drugs

Locations and Contacts

Siriraj Hospital, Bangkok 10700, Thailand
Additional Information

Starting date: November 2010
Last updated: October 7, 2012

Page last updated: August 23, 2015

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