Pemphigus Clinical Trial
Official title:
An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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