Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
Primary Purpose
Nail Psoriasis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fractional carbon dioxide laser
Tazarotene Cream 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Nail Psoriasis focused on measuring psoriasis, laser, nail
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group (A)
Group (B)
Arm Description
fractional carbon dioxide laser plus tazarotene 0.1% cream
Tazarotene Cream 0.1%
Outcomes
Primary Outcome Measures
percentage of clinically improved patients using modified nail psoriasis severity index.
clinical assessment using modified nail psoriasis severity index.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03263624
Brief Title
Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
Official Title
Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic: Nail Disease a Single-blind, Intrapatient Left-to-right Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The characteristic lesions affecting the nail present as 'oil drop' discoloration, splinter haemorrhages, subungual hyperkeratosis, and onycholysis in the nail bed or pitting, leuconychia, erythema of the lunula and crumbling in the nail matrix.Diagnosis is customarily made by patient history and physical examination, though it may be necessary to rule out onychomycosis as a differential diagnosis.
The nail psoriasis severity index has recently been reported as a possible reproducible, objective, and simple tool for clinical assessment of psoriatic nail disease.
The modified target nail psoriasis severity index has been proposed for target nail assessment which would give a degree of gradation for each parameter of 0 to 3 (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in each quadrant.The topical therapies include topical and intralesional corticosteroids , topical vitamin D3 analogues (calcipotriol) , topical tacrolimus and tazarotene[8]. The efficacy of these topical therapies in nail disease is limited mainly by the impenetrability or low penetrability of the nail and nail matrix. In patients with nail psoriasis that is resistant to topical therapies, conventional systemic therapies (e.g., phototherapy, retinoids, cyclosporine, methotrexate) have been shown to be partially effective. More recently, biological therapies (e.g., infliximab, adalimumab, alefacept, etanercept) have proven efficacy in psoriasis and psoriatic arthritis, and some are effective in treating nail disease in patients with psoriasis .
Previous study proved successful treatment of onychodystrophy using fractional carbon dioxide laser with topical steroid. Fractional Carbon dioxide laser might be an effective therapy for nail psoriasis due to its ablative ability which produce microscopic holes that perhaps improve topical drug delivery. Moreover it was hypothesized that tissue ablation and remodelling process stimulate rejuvenation of the abnormal nail bed.The investigators hypothesized that the combination of Fractional carbon dioxide laser and topical tazarotene treatment will have a higher therapeutic effect on nail psoriasis through multiple mechanism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Psoriasis
Keywords
psoriasis, laser, nail
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (A)
Arm Type
Experimental
Arm Description
fractional carbon dioxide laser plus tazarotene 0.1% cream
Arm Title
Group (B)
Arm Type
Active Comparator
Arm Description
Tazarotene Cream 0.1%
Intervention Type
Device
Intervention Name(s)
fractional carbon dioxide laser
Intervention Description
One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.
Intervention Type
Drug
Intervention Name(s)
Tazarotene Cream 0.1%
Intervention Description
tazarotene cream 0.1% once daily
Primary Outcome Measure Information:
Title
percentage of clinically improved patients using modified nail psoriasis severity index.
Description
clinical assessment using modified nail psoriasis severity index.
Time Frame
three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12879333
Citation
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Citation
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Citation
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Citation
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Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease
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