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Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03263624
Recruitment Status : Unknown
Verified August 2017 by Ayat Mahmoud, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
Ayat Mahmoud, Assiut University

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.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Device: fractional carbon dioxide laser Drug: Tazarotene Cream 0.1% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Group (A)
fractional carbon dioxide laser plus tazarotene 0.1% cream
Device: fractional carbon dioxide laser
One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.

Drug: Tazarotene Cream 0.1%
tazarotene cream 0.1% once daily

Active Comparator: Group (B)
Tazarotene Cream 0.1%
Drug: Tazarotene Cream 0.1%
tazarotene cream 0.1% once daily

Primary Outcome Measures :
  1. percentage of clinically improved patients using modified nail psoriasis severity index. [ Time Frame: three months ]
    clinical assessment using modified nail psoriasis severity index.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Ayat Mahmoud, Principal Investigator, Assiut University Identifier: NCT03263624    
Other Study ID Numbers: ltns
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayat Mahmoud, Assiut University:
Additional relevant MeSH terms:
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Nail Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Keratolytic Agents