Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
NCT ID: NCT05105139
Last Updated: 2022-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2021-11-29
2022-02-25
Brief Summary
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Detailed Description
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The researchers or the personnel designated by them will capture the information recorded by the treating physicians in the clinical file, sociodemographic, clinical and safety data that were presented after the prescription of Sebryl® and / or Sebryl Plus®.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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A1: Allantoin / Coal Tar / Clioquinol (Sebryl®)
Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 5.0 g/ 3.0 g Administration way: For scalp use
Allantoin/ Coal Tar/ Clioquinol
Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 5.0 g/ Clioquinol 3.0 g Administration way: For scalp use
A2: Allantoin/ Coal Tar/ Clioquinol/ Triclosan (Sebryl Plus®)
Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 3.0 g/ 3.0 g/ 0.3 g Administration way: For scalp use
Allantoin/ Coal Tar/ Clioquinol/ Triclosan
Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 3.0 g/ Clioquinol 3.0 g/ Triclosan 0.3 g. Administration way: For scalp us
Interventions
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Allantoin/ Coal Tar/ Clioquinol
Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 5.0 g/ Clioquinol 3.0 g Administration way: For scalp use
Allantoin/ Coal Tar/ Clioquinol/ Triclosan
Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 3.0 g/ Clioquinol 3.0 g/ Triclosan 0.3 g. Administration way: For scalp us
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with Sebryl® and / or Sebryl Plus® documented, for at least 2 consultations.
* That the patient has been questioned about possible adverse events
Exclusion Criteria
ALL
Yes
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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María E Morales Barrera, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent consultant
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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References
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Christophers E. Psoriasis--epidemiology and clinical spectrum. Clin Exp Dermatol. 2001 Jun;26(4):314-20. doi: 10.1046/j.1365-2230.2001.00832.x.
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996 Sep;35(9):633-9. doi: 10.1111/j.1365-4362.1996.tb03687.x.
Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014 Mar;70(3):512-6. doi: 10.1016/j.jaad.2013.11.013. Epub 2014 Jan 2.
Danielsen K, Olsen AO, Wilsgaard T, Furberg AS. Is the prevalence of psoriasis increasing? A 30-year follow-up of a population-based cohort. Br J Dermatol. 2013 Jun;168(6):1303-10. doi: 10.1111/bjd.12230.
Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
Ortonne J, Chimenti S, Luger T, Puig L, Reid F, Trueb RM. Scalp psoriasis: European consensus on grading and treatment algorithm. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1435-44. doi: 10.1111/j.1468-3083.2009.03372.x. Epub 2009 Jul 15.
Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
Sommer DM, Jenisch S, Suchan M, Christophers E, Weichenthal M. Increased prevalence of the metabolic syndrome in patients with moderate to severe psoriasis. Arch Dermatol Res. 2006 Dec;298(7):321-8. doi: 10.1007/s00403-006-0703-z. Epub 2006 Sep 22.
Gerdes S, Mrowietz U, Boehncke WH. [Comorbidity in psoriasis]. Hautarzt. 2016 Jun;67(6):438-44. doi: 10.1007/s00105-016-3805-3. German.
Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001 Mar;137(3):280-4.
Nast A, Kopp IB, Augustin M, Banditt KB, Boehncke WH, Follmann M, Friedrich M, Huber M, Kahl C, Klaus J, Koza J, Kreiselmaier I, Mohr J, Mrowietz U, Ockenfels HM, Orzechowski HD, Prinz J, Reich K, Rosenbach T, Rosumeck S, Schlaeger M, Schmid-Ott G, Sebastian M, Streit V, Weberschock T, Rzany B; Deutsche Dermatologische Gesellschaft (DDG); Berufsverband Deutscher Dermatologen (BVDD). Evidence-based (S3) guidelines for the treatment of psoriasis vulgaris. J Dtsch Dermatol Ges. 2007 Jul;5 Suppl 3:1-119. doi: 10.1111/j.1610-0387.2007.06172.x.
Pardasani AG, Feldman SR, Clark AR. Treatment of psoriasis: an algorithm-based approach for primary care physicians. Am Fam Physician. 2000 Feb 1;61(3):725-33, 736.
Borda LJ, Wikramanayake TC. Seborrheic Dermatitis and Dandruff: A Comprehensive Review. J Clin Investig Dermatol. 2015 Dec;3(2):10.13188/2373-1044.1000019. doi: 10.13188/2373-1044.1000019. Epub 2015 Dec 15.
Langner A, Wolska H, Hebborn P. Treatment of psoriasis of the scalp with coal tar gel and shampoo preparations. Cutis. 1983 Sep;32(3):290-1, 295-6.
Puig L, Ribera M, Hernanz JM, Belinchon I, Santos-Juanes J, Linares M, Querol I, Colome E, Caballe G. [Treatment of scalp psoriasis: review of the evidence and Delphi consensus of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology]. Actas Dermosifiliogr. 2010 Dec;101(10):827-46. Spanish.
Other Identifiers
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SIL-31103-IV-21(1)
Identifier Type: -
Identifier Source: org_study_id
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