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Completed

NCT Number: NCT01703325

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1% triamcinolone , 0.05% clobetasol propionate ointment

Drug

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 names: Dermovate ointment

Primary outcomes

  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

    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2012
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.