Comparison of Efficacy of Intralesional Triamcinolone Injection and Clobetasol Propionate Ointment for Psoriatic Nails
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ClinicalTrials.gov Identifier: NCT01703325 |
Recruitment Status :
Completed
First Posted : October 10, 2012
Last Update Posted : October 10, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
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Psoriatic Nails | Drug: 0.1% triamcinolone , 0.05% clobetasol propionate ointment | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | November 2010 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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Active Comparator: triamcinolone injection (10 mg/ml)
Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection |
Drug: 0.1% triamcinolone , 0.05% clobetasol propionate ointment
Three finger nails are chosen from the equally average NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C
Other Name: Dermovate ointment |
Active Comparator: Topical 0.05% clobetasol ointment
Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Apply Topical 0.05% clobetasol propionate ointment on the nail fold twice daily for 6 months
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Drug: 0.1% triamcinolone , 0.05% clobetasol propionate ointment
Three finger nails are chosen from the equally average NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C
Other Name: Dermovate ointment |
No Intervention: Controlled group
Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Controlled group
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- 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 [ Time Frame: 6 months ]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.
- adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment [ Time Frame: 6 months ]Observe the possible adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment treatment for psoriatic nails.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects aged over 18 years old who have at least 3 psoriatic finger nails resembly severity
Exclusion Criteria:
- Patients are receiving the systemic therapy of psoriasis
- Patients discontinued the systemic therapy less than 3 months and topical therapy less than 1 month
- Positive results for the microscopic study of fungus in finger nails
- History of steroids or EMLA allergy
- Pregnancy or nursing
- Any skin infection at the site of the treatment
- Human immunodeficiency virus subjects
- History of malignancy or during the treatment of malignancy
- Patients who have psychological disorder
- Patients who have bleeding disorder or receiving anticoagulation drugs

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): NCT01703325
Thailand | |
Siriraj Hospital | |
Bangkok, Thailand, 10700 |
Principal Investigator: | Chanisada Wongpraparut, M.D. | Faculty of Medicine Siriraj Hospital |
Responsible Party: | chanisada tuchinda, Assistant Professor, Mahidol University |
ClinicalTrials.gov Identifier: | NCT01703325 |
Other Study ID Numbers: |
Si599/2010 |
First Posted: | October 10, 2012 Key Record Dates |
Last Update Posted: | October 10, 2012 |
Last Verified: | October 2012 |
Psoriatic nails Triamcinolone injection clobetasol propionate |
Triamcinolone Clobetasol Anti-Inflammatory Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |