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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | June 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital General Dr Manuel Gea González | Mexico | DF |
Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico | DF |
Lead Sponsor | Collaborator |
---|---|
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
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. — View Citation
Asz 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. — View Citation
Chen 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. — View Citation
Daróczy J, Szalai I. [Use of polyurethane foil for wound covering]. Orv Hetil. 1991 Jun 2;132(22):1203-4. Hungarian. — View Citation
Dressler DP, Skornik WA. Burn wound dressings. II. Effect on wound sepsis. J Trauma. 1971 Apr;11(4):325-30. — View Citation
Dumas V, Roujeau JC, Wolkenstein P, Revuz J, Cosnes A. The treatment of mild pemphigus vulgaris and pemphigus foliaceus with a topical corticosteroid. Br J Dermatol. 1999 Jun;140(6):1127-9. — View Citation
Grando SA. New approaches to the treatment of pemphigus. J Investig Dermatol Symp Proc. 2004 Jan;9(1):84-91. — View Citation
Gravante 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. Review. — View Citation
Joly 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. — View Citation
Khumalo NP, Murrell DF, Wojnarowska F, Kirtschig G. A systematic review of treatments for bullous pemphigoid. Arch Dermatol. 2002 Mar;138(3):385-9. Review. — View Citation
Kirtschig G, Khumalo NP. Management of bullous pemphigoid: recommendations for immunomodulatory treatments. Am J Clin Dermatol. 2004;5(5):319-26. Review. — View Citation
Kirtschig G, Middleton P, Bennett C, Murrell DF, Wojnarowska F, Khumalo NP. Interventions for bullous pemphigoid. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD002292. doi: 10.1002/14651858.CD002292.pub3. Review. — View Citation
Martin LK, Werth V, Villanueva E, Segall J, Murrell DF. Interventions for pemphigus vulgaris and pemphigus foliaceus. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006263. doi: 10.1002/14651858.CD006263.pub2. Review. — View Citation
Mimouni 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. — View Citation
Murrell 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. — View Citation
Mutasim 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. — View Citation
Patange VS, Fernandez RJ, Motla MU, Mahajan SA. Dressing wounds with potato peel. Indian J Dermatol Venereol Leprol. 1996 Sep-Oct;62(5):286-8. — View Citation
Sibbald 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. — View Citation
Vun YY, Lun K, Strutton G. Use of biosynthetic dressings in paraneoplastic pemphigus. Australas J Dermatol. 2004 May;45(2):133-5. — View Citation
Wojnarowska 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. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound Healing Percentage of a 64 cm2 area of epithelialized skin | Percentage of a 64 cm2 area of epithelialized skin | 42 days | No |
Secondary | Pain Using the visual analog scale a decrease in pain score | Using the visual analog scale a decrease in pain score | 42 days | No |
Secondary | Itch Using the visual analog scale a decrease in itch score | Using the visual analog scale a decrease in itch score | 42 days | No |
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