NCT03263624

Brief Summary

Nail psoriasis has a high incidence amongst patients with psoriasis.It is estimated to affect 80% of psoriatic patients at some time during their lives and has a significant adverse influence on their quality of life. Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with conventional therapies often having little effect.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 23, 2017

Last Update Submit

August 25, 2017

Conditions

Nail Psoriasis

Keywords

psoriasislasernail

Outcome Measures

Primary Outcomes (1)

  • percentage of clinically improved patients using modified nail psoriasis severity index.

    clinical assessment using modified nail psoriasis severity index.

    three months

Study Arms (2)

Group (A)

EXPERIMENTAL

fractional carbon dioxide laser plus tazarotene 0.1% cream

Device: fractional carbon dioxide laserDrug: Tazarotene Cream 0.1%

Group (B)

ACTIVE COMPARATOR

Tazarotene Cream 0.1%

Drug: Tazarotene Cream 0.1%

Interventions

fractional carbon dioxide laserDEVICE

One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.

Group (A)
Tazarotene Cream 0.1%DRUG

tazarotene cream 0.1% once daily

Group (A)Group (B)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Thirty patients with bilateral fingernail psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital.
  • The diagnosis will be based upon the clinical characteristics of nail psoriasis.
  • Patients will be included after they have stopped any systemic therapy for at least 8 weeks

You may not qualify if:

  • pregnant or lactating woman
  • patients with history of photosensitivity.
  • Patients who discontinued or just started to receive new systemic therapy or phototherapy during the study period will be dropped from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Salomon J, Szepietowski JC, Proniewicz A. Psoriatic nails: a prospective clinical study. J Cutan Med Surg. 2003 Jul-Aug;7(4):317-21. doi: 10.1007/s10227-002-0143-0. Epub 2003 Jul 28.

    PMID: 12879333BACKGROUND

  • Sanchez-Regana M, Aldunce Soto MJ, Belinchon Romero I, Ribera Pibernat M, Lafuente-Urrez RF, Carrascosa Carrillo JM, Ferrandiz Foraster C, Puig Sanz L, Dauden Tello E, Vidal Sarro D, Ruiz-Villaverde R, Fonseca Capdevila E, Rodriguez Cerdeira MC, Alsina Gibert MM, Herrera Acosta E, Marron Moya SE; en representacion del Grupo Espanol de Psoriasis de la Academia Espanola de Dermatologia y Venereologia. Evidence-based guidelines of the spanish psoriasis group on the use of biologic therapy in patients with psoriasis in difficult-to-treat sites (nails, scalp, palms, and soles). Actas Dermosifiliogr. 2014 Dec;105(10):923-34. doi: 10.1016/j.ad.2014.02.015. Epub 2014 May 19. English, Spanish.

    PMID: 24852726BACKGROUND

  • Grover C, Reddy BS, Uma Chaturvedi K. Diagnosis of nail psoriasis: importance of biopsy and histopathology. Br J Dermatol. 2005 Dec;153(6):1153-8. doi: 10.1111/j.1365-2133.2005.06862.x.

    PMID: 16307651BACKGROUND

  • Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. J Am Acad Dermatol. 2003 Aug;49(2):206-12. doi: 10.1067/s0190-9622(03)00910-1.

    PMID: 12894066BACKGROUND

  • Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9.

    PMID: 17216680BACKGROUND

  • Oram Y, Akkaya AD. Treatment of nail psoriasis: common concepts and new trends. Dermatol Res Pract. 2013;2013:180496. doi: 10.1155/2013/180496. Epub 2013 May 13.

    PMID: 23762032BACKGROUND

  • Jiaravuthisan MM, Sasseville D, Vender RB, Murphy F, Muhn CY. Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy. J Am Acad Dermatol. 2007 Jul;57(1):1-27. doi: 10.1016/j.jaad.2005.07.073.

    PMID: 17572277BACKGROUND

  • Lim EH, Seo YJ, Lee JH, Im M. Onychodystrophy treated using fractional carbon dioxide laser therapy and topical steroids: new treatment options for nail dystrophy. Dermatol Surg. 2013 Dec;39(12):1931-3. doi: 10.1111/dsu.12365. Epub 2013 Oct 26. No abstract available.

    PMID: 24164919BACKGROUND

  • Rigopoulos D, Gregoriou S, Katsambas A. Treatment of psoriatic nails with tazarotene cream 0.1% vs. clobetasol propionate 0.05% cream: a double-blind study. Acta Derm Venereol. 2007;87(2):167-8. doi: 10.2340/00015555-0195. No abstract available.

    PMID: 17340027BACKGROUND

  • Velez NF, Jellinek NJ. Response to onychodystrophy treated using fractional carbon dioxide laser therapy and topical steroids. Dermatol Surg. 2014 Jul;40(7):801-2. doi: 10.1111/DSU.0000000000000036. No abstract available.

    PMID: 25111355BACKGROUND

  • Fischer-Levancini C, Sanchez-Regana M, Llambi F, Collgros H, Exposito-Serrano V, Umbert-Millet P. Nail psoriasis: treatment with tazarotene 0.1% hydrophilic ointment. Actas Dermosifiliogr. 2012 Oct;103(8):725-8. doi: 10.1016/j.ad.2012.04.008. Epub 2012 Jul 19. English, Spanish.

    PMID: 22818395BACKGROUND

  • Treewittayapoom C, Singvahanont P, Chanprapaph K, Haneke E. The effect of different pulse durations in the treatment of nail psoriasis with 595-nm pulsed dye laser: a randomized, double-blind, intrapatient left-to-right study. J Am Acad Dermatol. 2012 May;66(5):807-12. doi: 10.1016/j.jaad.2011.12.015. Epub 2012 Jan 13.

    PMID: 22243768BACKGROUND

  • Maranda EL, Nguyen AH, Lim VM, Hafeez F, Jimenez JJ. Laser and light therapies for the treatment of nail psoriasis. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1278-84. doi: 10.1111/jdv.13678. Epub 2016 May 26.

    PMID: 27226341BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

August 28, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share