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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 March 2015 |
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Main ID: |
NCT02365675 |
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Date of registration:
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11/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Wound Dressings for Pemphigus and Pemphigoid
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Scientific title:
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An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02365675 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Jose Contreras-Ruiz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital General Dr Manuel Gea Gonzalez |
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Name:
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Jose Contreras-Ruiz, MD |
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Address:
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Telephone:
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+525540003000 |
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Email:
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dermayheridas@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of pemphigus vulgaris, pemphigus foliaceus , pemphigus vegetans,
paraneoplastic pemphigus or bullous pemphigoid
- At least four areas of active disease in the trunk or limbs of 8 x 8 cm characterized
by denudation, ulceration, scabs or blisters.
- Capable of being evaluated weekly either as outpatient or hospitalized
- Actively treated with immunosuppressive or immunomodulatory drugs for pemphigus or
pemphigoid control
- Willing to sign an informed consent
Exclusion Criteria:
- Patients with hypersensitivity to any of the components of the skin dressings that
will be used.
- Patients who have participated in any clinical trial in the last 30 days.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pemphigoid
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Pemphigus
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Intervention(s)
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Device: Carboxymethylcellulose with ionic silver (Aquacel Ag)
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Device: Nanocrystalline silver (Acticoat)
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Device: Cotton gauze with petrolatum
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Device: Cellulose acetate with petrolatum
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Primary Outcome(s)
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Wound Healing Percentage of a 64 cm2 area of epithelialized skin
[Time Frame: 42 days]
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Secondary Outcome(s)
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Pain Using the visual analog scale a decrease in pain score
[Time Frame: 42 days]
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Itch Using the visual analog scale a decrease in itch score
[Time Frame: 42 days]
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Secondary ID(s)
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06-106-2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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