PemphigusNCT02365675
Wound Dressings for Pemphigus and Pemphigoid
A study testing Cotton gauze with petrolatum, Cellulose acetate with petrolatum and Nanocrystalline silver (Acticoat) in people with Pemphigus and Pemphigoid, run by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus, Pemphigoid
- What is being tested?
- Cotton gauze with petrolatum, Cellulose acetate with petrolatum and Nanocrystalline silver (Acticoat)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesMexico
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
Judith Dominguez-Cherit, MD, +525554870900 ext. 4586, judom59@hotmail.com
Rodrigo Cepeda, MD, +525554870900 ext. 4586, dr.rcepeda@gmail.com
- Recruiting
Hospital General Dr Manuel Gea González
Mexico City, Mexico City, 14080
Jose Contreras-Ruiz, MD, +525540003000 ext. 3502, dermayheridas@gmail.com
Karla Lopez-Ortiz, MD, +5215585583329, karlitaav24@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Pemphigus, Pemphigoid
- Being tested
- Cotton gauze with petrolatum, Cellulose acetate with petrolatum, Nanocrystalline silver (Acticoat), Carboxymethylcellulose with ionic silver (Aquacel Ag)
- Keywords
- Pemphigus, Pemphigoid, Wound Healing, Itch, Pain, Wound dressing, Topical treatment
- Medical subject headings
- Pemphigus, Pemphigoid, Bullous, Pruritus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotton gauze with petrolatumDevice
Cellulose acetate with petrolatumDevice
Also called Curity non-adhering dressing
Nanocrystalline silver (Acticoat)Device
Also called Acticoat
Carboxymethylcellulose with ionic silver (Aquacel Ag)Device
Also called Aquacel Ag
| Study group | Role | What they receive |
|---|---|---|
| Cotton gauze with petrolatum | Active comparator | The dressing to be used is regular cotton gauze impregnated in petrolatum (a mixture of solid hydrocarbons) creating a film that reduces the adherence of the gauze to the wound. Receives: Device: Cotton gauze with petrolatum |
| Cellulose acetate with petrolatum | Active comparator | The dressing to be used is a mesh or tulle base of cellulose acetate polymers that do not easily adhere to the wound impregnated in petrolatum (a mixture of solid hydrocarbons). Receives: Device: Cellulose acetate with petrolatum |
| Nanocrystalline silver | Active comparator | The dressing to be used consists of two layers of a silver-coated, high-density polyethylene mesh, enclosing a single layer of an apertured non-woven fabric of rayon and polyester. The three components are ultrasonically welded together to maintain the integrity of the dressing in use. Silver is applied to the polyethylene mesh by a vapour deposition process, which results in the formation of microscopic 'nanocrystals' of metallic silver. Receives: Device: Nanocrystalline silver (Acticoat) |
| Carboxymethylcellulose with ionic silver | Active comparator | The dressing to be used is a soft, sterile, non- woven pad dressing made from sodium carboxymethylcellulose containing 1.2% silver in an ionic form. Receives: Device: Carboxymethylcellulose with ionic silver (Aquacel Ag) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Percentage of a 64 cm2 area of epithelialized skin
Measured: 42 days
Secondary outcomes (2)
Pain Using the visual analog scale a decrease in pain score
Using the visual analog scale a decrease in pain score
Measured: 42 days
Itch Using the visual analog scale a decrease in itch score
Using the visual analog scale a decrease in itch score
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for PemphigusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Responsible party
- Principal investigator, Jose Contreras-Ruiz, Hospital General Dr. Manuel Gea González
- Investigators
- Jose Contreras-Ruiz, MD, Principal investigator, Hospital General Dr Manuel Gea Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365675
- Sponsor's protocol ID
- 06-106-2014
- Status last verified
- Sep 2014
- First submitted
- 11 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Amagai M. Preface to Journal of Dermatology special issue: pemphigus updates from around the world. J Dermatol. 2015 Jan;42(1):2. doi: 10.1111/1346-8138.12774. No abstract available.
PubMed 25558945Mimouni D, Anhalt GJ, Lazarova Z, Aho S, Kazerounian S, Kouba DJ, Mascaro JM Jr, Nousari HC. Paraneoplastic pemphigus in children and adolescents. Br J Dermatol. 2002 Oct;147(4):725-32. doi: 10.1046/j.1365-2133.2002.04992.x.
PubMed 12366419Mutasim DF. Autoimmune bullous dermatoses in the elderly: an update on pathophysiology, diagnosis and management. Drugs Aging. 2010 Jan 1;27(1):1-19. doi: 10.2165/11318600-000000000-00000.
PubMed 20030429Kirtschig G, Khumalo NP. Management of bullous pemphigoid: recommendations for immunomodulatory treatments. Am J Clin Dermatol. 2004;5(5):319-26. doi: 10.2165/00128071-200405050-00005.
PubMed 15554733Martin LK, Werth V, Villanueva E, Segall J, Murrell DF. Interventions for pemphigus vulgaris and pemphigus foliaceus. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006263. doi: 10.1002/14651858.CD006263.pub2.
PubMed 19160272Joly P, Roujeau JC, Benichou J, Delaporte E, D'Incan M, Dreno B, Bedane C, Sparsa A, Gorin I, Picard C, Tancrede-Bohin E, Sassolas B, Lok C, Guillaume JC, Doutre MS, Richard MA, Caux F, Prost C, Plantin P, Chosidow O, Pauwels C, Maillard H, Saiag P, Descamps V, Chevrant-Breton J, Dereure O, Hellot MF, Esteve E, Bernard P. A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study. J Invest Dermatol. 2009 Jul;129(7):1681-7. doi: 10.1038/jid.2008.412. Epub 2009 Jan 29.
PubMed 19177141Wojnarowska F, Kirtschig G, Highet AS, Venning VA, Khumalo NP; British Association of Dermatologists. Guidelines for the management of bullous pemphigoid. Br J Dermatol. 2002 Aug;147(2):214-21. doi: 10.1046/j.1365-2133.2002.04835.x.
PubMed 12174090Khumalo NP, Murrell DF, Wojnarowska F, Kirtschig G. A systematic review of treatments for bullous pemphigoid. Arch Dermatol. 2002 Mar;138(3):385-9. doi: 10.1001/archderm.138.3.385.
PubMed 11902990Kirtschig G, Middleton P, Bennett C, Murrell DF, Wojnarowska F, Khumalo NP. Interventions for bullous pemphigoid. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD002292. doi: 10.1002/14651858.CD002292.pub3.
PubMed 20927731Dressler DP, Skornik WA. Burn wound dressings. II. Effect on wound sepsis. J Trauma. 1971 Apr;11(4):325-30. No abstract available.
PubMed 5551730Sibbald RG, Contreras-Ruiz J, Coutts P, Fierheller M, Rothman A, Woo K. Bacteriology, inflammation, and healing: a study of nanocrystalline silver dressings in chronic venous leg ulcers. Adv Skin Wound Care. 2007 Oct;20(10):549-58. doi: 10.1097/01.ASW.0000294757.05049.85.
PubMed 17906429Gravante G, Caruso R, Sorge R, Nicoli F, Gentile P, Cervelli V. Nanocrystalline silver: a systematic review of randomized trials conducted on burned patients and an evidence-based assessment of potential advantages over older silver formulations. Ann Plast Surg. 2009 Aug;63(2):201-5. doi: 10.1097/SAP.0b013e3181893825.
PubMed 19571738Asz J, Asz D, Moushey R, Seigel J, Mallory SB, Foglia RP. Treatment of toxic epidermal necrolysis in a pediatric patient with a nanocrystalline silver dressing. J Pediatr Surg. 2006 Dec;41(12):e9-12. doi: 10.1016/j.jpedsurg.2006.08.043.
PubMed 17161178Chen J, Han CM, Lin XW, Tang ZJ, Su SJ. [Effect of silver nanoparticle dressing on second degree burn wound]. Zhonghua Wai Ke Za Zhi. 2006 Jan 1;44(1):50-2. Chinese.
PubMed 16620649Murrell DF, Daniel BS, Joly P, Borradori L, Amagai M, Hashimoto T, Caux F, Marinovic B, Sinha AA, Hertl M, Bernard P, Sirois D, Cianchini G, Fairley JA, Jonkman MF, Pandya AG, Rubenstein D, Zillikens D, Payne AS, Woodley D, Zambruno G, Aoki V, Pincelli C, Diaz L, Hall RP, Meurer M, Mascaro JM Jr, Schmidt E, Shimizu H, Zone J, Swerlick R, Mimouni D, Culton D, Lipozencic J, Bince B, Grando SA, Bystryn JC, Werth VP. Definitions and outcome measures for bullous pemphigoid: recommendations by an international panel of experts. J Am Acad Dermatol. 2012 Mar;66(3):479-85. doi: 10.1016/j.jaad.2011.06.032. Epub 2011 Nov 5.
PubMed 22056920
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
- ClinicalTrials.gov ID
- NCT02365675
- Acronym / sponsor ID
- 06-106-2014
- Conditions
- Pemphigus, Pemphigoid
- Keywords
- Pemphigus, Pemphigoid, Wound Healing, Itch, Pain, Wound dressing, Topical treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.University, hospital or other
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cotton gauze with petrolatum | Active comparator | Device: Cotton gauze with petrolatumThe dressing to be used is regular cotton gauze impregnated in petrolatum (a mixture of solid hydrocarbons) creating a film that reduces the adherence of the gauze to the wound. |
| Cellulose acetate with petrolatum | Active comparator | Device: Cellulose acetate with petrolatumThe dressing to be used is a mesh or tulle base of cellulose acetate polymers that do not easily adhere to the wound impregnated in petrolatum (a mixture of solid hydrocarbons). |
| Nanocrystalline silver | Active comparator | Device: Nanocrystalline silver (Acticoat)The dressing to be used consists of two layers of a silver-coated, high-density polyethylene mesh, enclosing a single layer of an apertured non-woven fabric of rayon and polyester. The three components are ultrasonically welded together to maintain the integrity of the dressing in use. Silver is applied to the polyethylene mesh by a vapour deposition process, which results in the formation of microscopic 'nanocrystals' of metallic silver. |
| Carboxymethylcellulose with ionic silver | Active comparator | Device: Carboxymethylcellulose with ionic silver (Aquacel Ag)The dressing to be used is a soft, sterile, non- woven pad dressing made from sodium carboxymethylcellulose containing 1.2% silver in an ionic form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cotton gauze with petrolatum | Device | Cotton gauze with petrolatum |
| Cellulose acetate with petrolatumAlso: Curity non-adhering dressing | Device | Cellulose acetate with petrolatum |
| Nanocrystalline silver (Acticoat)Also: Acticoat | Device | Nanocrystalline silver |
| Carboxymethylcellulose with ionic silver (Aquacel Ag)Also: Aquacel Ag | Device | Carboxymethylcellulose with ionic silver |
Primary outcome
Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Time frame: 42 days
Percentage of a 64 cm2 area of epithelialized skin
2 secondary outcomes
Pain Using the visual analog scale a decrease in pain score
Time frame: 42 days
Itch Using the visual analog scale a decrease in itch score
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Background: PubMed 25558945Amagai M. Preface to Journal of Dermatology special issue: pemphigus updates from around the world. J Dermatol. 2015 Jan;42(1):2. doi: 10.1111/1346-8138.12774. No abstract available.
- Background: PubMed 12366419Mimouni D, Anhalt GJ, Lazarova Z, Aho S, Kazerounian S, Kouba DJ, Mascaro JM Jr, Nousari HC. Paraneoplastic pemphigus in children and adolescents. Br J Dermatol. 2002 Oct;147(4):725-32. doi: 10.1046/j.1365-2133.2002.04992.x.
- Background: PubMed 20030429Mutasim DF. Autoimmune bullous dermatoses in the elderly: an update on pathophysiology, diagnosis and management. Drugs Aging. 2010 Jan 1;27(1):1-19. doi: 10.2165/11318600-000000000-00000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Contreras-Ruiz, MD principal investigator
Hospital General Dr Manuel Gea Gonzalez
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cotton gauze with petrolatum, Cellulose acetate with petrolatum and Nanocrystalline silver (Acticoat) in people with Pemphigus and Pemphigoid, run by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Contreras-Ruiz, MD (+525540003000 ext. 3502, dermayheridas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Percentage of a 64 cm2 area of epithelialized skin (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365675, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.