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
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