Psoriatic Nails Clinical Trial
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
| Verified date | October 2012 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | June 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Siriraj Hospital | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 1. To compare the percent change in the NAPSI (Nail Psoriasis Severity Index) score of Psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment and controlled untreated group. | 6 months | No |
| Secondary | adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment | Observe the possible adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment treatment for psoriatic nails. | 6 months | Yes |