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

NCT ID: NCT01703325

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriatic Nails

Keywords

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Psoriatic nails Triamcinolone injection clobetasol propionate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

0.1% triamcinolone , 0.05% clobetasol propionate ointment

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

0.1% triamcinolone , 0.05% clobetasol propionate ointment

Intervention Type 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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Dermovate ointment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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chanisada tuchinda

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chanisada Wongpraparut, M.D.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si599/2010

Identifier Type: -

Identifier Source: org_study_id