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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
Sponsor:
Information provided by (Responsible Party):
chanisada tuchinda, Mahidol University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Psoriatic Nails Drug: 0.1% triamcinolone , 0.05% clobetasol propionate ointment Phase 4

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.

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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

  • 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
  • Group B: Apply Topical 0.05% clobetasol propionate ointment (Dermovate®) on the nail fold twice daily for 6 months
  • Group C: Controlled group
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
 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

  • 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
  • Group B: Apply Topical 0.05% clobetasol propionate ointment (Dermovate®) on the nail fold twice daily for 6 months
  • Group C: Controlled group
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Chanisada Wongpraparut, M.D. Faculty of Medicine Siriraj Hospital
More Information
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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
Keywords provided by chanisada tuchinda, Mahidol University:
Psoriatic nails
Triamcinolone injection
clobetasol propionate
Additional relevant MeSH terms:
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Triamcinolone
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs