Clinical trial NCT02365675: Wound Dressings for Pemphigus and Pemphigoid
Official title: An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pemphigus
Pemphigoid
Keywords: Pemphigus
Pemphigoid
Wound Healing
Itch
Pain
Wound dressing
Topical treatment
Lead sponsor: Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
First posted: 2015-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of four dressings (covers) namely: gauze with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with silver and nanocrystalline silver to improve the new growth of skin, reduce pain and itch in persons suffering from pemphigus and pemphigoid.

Detailed description: Pemphigus and pemphigoid are the most frequently autoinmune bullous diseases seen in dermatology. Despite all the treatments that have been studied for the management of bullous skin diseases, there is insufficient information about the best skin dressing or cover that can be used in affected or denuded areas in these conditions.

Therefore we will compare the efficacy of four different covers (gauze with petrolatum , cellulose acetate with petrolatum , pure carboxymethylcellulose with silver and nanocrystalline silver) in providing faster healing and decreasing pain and itch.

Each patient with the diagnosis of either pemphigus or pemphigoid will have a full skin examination and 4 of the most affected areas will be randomly assigned to receive each of the 4 treatments previously described.

There is no clinical study focused specifically on the materials that will be used in this study. There are few isolated cases reported that can not be taken as a basis. Considering the above and based on the clinical experience, we consider it appropriate to conduct a pilot study with a total of 10-14 patients, with it we will perform a sample calculation, considering a potential alpha error of 0.05, yielding the beta error by subtracting 1.0 to the power sample calculated .

In all of the patients 4 affected areas of 8 cm x 8 cm ( 64 cm2 ) will be selected and marked with the letters A, B , C and D. The investigator will generate randomization tables where previously established and numbered treatments 1 to 4 will be randomly assigned to each of the four areas. Thus all patients will receive the 4 therapies but randomly in the 4 areas previously selected.

The variables that will be studied are:

* Total area affected : Consists of the sum of the percentages of skin that is not healthy in the 64 cm2
* Intensity of pain: sensory unpleasant emotional experience that occurs from the potential or actual injury tissue . Will be assessed by visual analog scale, validated method.
* Erythema: Inflammation of the skin surface caused by excess blood supply, causing redness.
* Itch: cutaneous unpleasant sensation and of variable intensity that causes an urge to scratch to get relief. Will be assessed by visual analog scale, validated method.
* Healing: Reparing process of an altered tissue, resulting in the formation of a scar tissue. Will be measured based on the reduction of wound area percentage. It shall be measured in cm2 with ImageJ® program ( ImageJ® , US National Institutes of Health , Bethesda , Maryland , USA , ( http : //imagej.nih.gov/ij/ ) ) .
* Ulcer: injury depressed by loss of epidermis, dermis and subcutaneous tissue . They will be measured in total area in cm2 by ImageJ® program.
* Blisters, pustules or vesicles: are elemental skin lesions with a liquid content ranging from light to heavy white. They will be measured in total area in cm2 by ImageJ® program.

Procedure description:

Day 0

* The patient will be evaluated to determine if is eligible according to the selection criteria.
* The protocol will be explained in clear words so that the patient understands it.
* The patient will have to sign the informed consent.
* Total body surface area will be revalutatd to select the 4 most severely affected areas in the trunk or limbs of 8 cm x 8 cm each and that will be assigned with a letter from A to D.
* With an indelible marker the 4 vertices of each of the previously selected areas will be marked.
* A label graduated in millimeters will be placed at the bottom edge of the marked areas.
* A panoramic picture of each of the four areas will be taken to ensure that if the label is lost, we can replicate it in the next visit.
* An aproach picture of each of these four areas will be taken.
* The selected areas will be cleaned with sterile saline.
* Clinical evaluation will be performed and the section of the report format will be filled.
* The envelope containing randomization numbers will be opened to decide which dressing skin cover will be used to each of the selected areas.
* The dressings (covers) will be placed on each of the selected areas. Above it conventional gauze will be placed and this cure will be pinned up with conventional elastic white band.
* The patient will recieve the appointments of the 6 subsequent valorations.
* The patient will recive the prescription for the systemic management of the bullous skin disease.
* The patient will receive a second prescription explaining how he should be healing between each visit. If it is an inpatient, the healing and measurement will be performed by the medical personnel assigned. The family will be explained how to perform the healing and at the end of his hospital stay a prescription will be given with the instructions. Also the next control appointment will be given.
* Pictures will be downloaded and the presence of abnormal skin will be measured using a standardized measurement program ( ImageJ® , US NationalInstitutes of Health , Bethesda , Maryland , USA , ( http://imagej.nih.gov/ij/ ) ). All data obtained will be registered in the report format made specifically for this trial.

Subsequent visits ( 7, 14, 21 , 28, 35 )

* The presence of systemic or local adverse effects at any of the 4 areas of study will be asked.
* The 4 areas will be discovered using saline and gently drying. The healling and the further steps are the same as the ones explained above.
* All the data obtained will be recorded on the report format.

Final visit (day 42)

* The patient will be told he or she is no more in the protocol and which of the dressings worked the best.
* The patient will receive his or her next appoinment.
* A prescription with the systemic treatment will be given.
* A second prescription will be given, explaining how to perform the healings.
* All data obtained will be recorded to the further results analysis.

Results will be presented as percentages or proportions for categorical variables and by mean ± standard deviation for continuous variables. The percentage of epithelialization between the four groups will be compared with Chi Square RxC. Continuous numerical variables will be compared with one way ANOVA in the case of homoscedastic variances or by Kruskall Wallis variance in the case of heteroskedastic variances. The results will be adjusted in relation to the received systemic treatment (duration, intensity), the location of the lesions and its chronicity with multivariate lienal regression analysis . For bivariate anaysis a significant value of p \< 0.05 will be used. For multivariate analysis a p \< 0.10 value will be used. STATA version 13.0 for Mac wiil be used.

Tables and grapfhs will be used to present the results.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Healing Percentage of a 64 cm2 area of epithelialized skin
timeFrame: 42 days
Secondary outcomes:
measure: Pain Using the visual analog scale a decrease in pain score
timeFrame: 42 days
measure: Itch Using the visual analog scale a decrease in itch score
timeFrame: 42 days
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
city: Mexico
country: Mexico
facility: Hospital General Dr Manuel Gea González
state: DF
Study officials:
affiliation: Hospital General Dr Manuel Gea Gonzalez
name: Jose Contreras-Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
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