Nail Psoriasis Clinical Trial
Official title:
Effect of Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Patients With Nail Psoriasis
The primary aim of the study is to assess the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy.
Nail psoriasis is one of the risk factors for psoriatic arthritis (PsA), especially with
distal interphalangeal joints affected. Nail changes in psoriasis have been observed in
10-55% of patients, and the nail psoriasis-related inflammation can spread to adjacent
structures, including DIP joints and digital extensor tendons. Enthesopathies are among the
characteristic features of psoriatic arthritis. In everyday practice, assessment of psoriatic
changes in nails is based mainly on clinical indices, such as nail psoriasis severity index
(NAPSI) and modified NAPSI (mNAPSI), while imaging examinations, such as ultrasonography are
performed much less frequently.
The findings of this study may assess the reasonableness of systemic treatment of nail
psoriasis in patients without arthritis as enthesopathy prevention as well as the usability
of US nail examinations in Ps and PsA patients in assessment of morphological changes and a
response to treatment.
A US examination of nails and distal interphalangeal joint extensor tendons are conducted in
all of the patients twice at an interval of six months. The examination is conducted by a
rheumatologist experienced in ultrasound examinations of the skeletal and muscular system. An
assessment of the nails, extensor tendons and DIP joints is made by placing the head on the
dorsal side. In order to avoid pressure on surface tissues, an appropriate amount of gel
without gel pads was used. The intensified blood flow, made visible by the PD technique, is
confirmed by pulsed wave Doppler spectrum. The nail thickness is measured as the maximum
distance between the dorsal and ventral nail plates. The nail bed thickness is measured as
the distance between the ventral plate and the bone margin of the distal phalanx. The nail
matrix thickness is measured at the proximal end of the nail bed.
The study was approved by the Bioethics Committee of the Warmia and Mazury Chamber of
Physicians The study are conducted according to the Good Clinical Practice guidelines. Each
participant signs an informed consent and be coded with unique ID.
Results of analyses will be saved by indexing with ID code only, personal data with
individual IDs will be saved in additional file. All hard copy will be archived in secure
room with coded electronic key.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03209388 -
Study of the Efficacy and Safety of Topical P-3073 in the Treatment of Mild to Moderate Psoriatic Fingernail/s
|
Phase 3 | |
| Completed |
NCT00999687 -
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
|
Phase 2/Phase 3 | |
| Completed |
NCT00581100 -
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
|
Phase 4 | |
| Completed |
NCT04580537 -
Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails
|
Phase 2 | |
| Not yet recruiting |
NCT03263624 -
Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
|
Phase 4 | |
| Completed |
NCT02606760 -
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
|
Phase 3 | |
| Completed |
NCT04227288 -
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
|
Phase 4 | |
| Withdrawn |
NCT03079973 -
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s
|
Phase 3 | |
| Completed |
NCT04380597 -
Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life
|
||
| Completed |
NCT03991936 -
Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis
|
Phase 4 | |
| Recruiting |
NCT05124080 -
An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis
|
Early Phase 1 | |
| Completed |
NCT02016482 -
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
|
Phase 3 | |
| Completed |
NCT02168933 -
308nm Excimer Laser for Treatment of Fingernail Psoriasis
|
N/A | |
| Completed |
NCT01445886 -
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05695833 -
Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis
|
N/A | |
| Completed |
NCT03616561 -
Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)
|
||
| Completed |
NCT02235480 -
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis
|
Phase 2 | |
| Not yet recruiting |
NCT06150794 -
Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis
|
N/A | |
| Completed |
NCT03946826 -
A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis
|
N/A | |
| Active, not recruiting |
NCT05072886 -
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
|
Phase 1 |