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Observational, descriptive, retrospective, multicenter study to evaluate the safety of the treatment with Sebryl® and / or Sebryl Plus® in the management of seborrheic dermatitis and psoriasis of the scalp in routine medical practice.
The objective of this study is to evaluate the frequency and intensity of adverse events presented during treatment with Sebryl® and / or Sebryl Plus® for the management of seborrheic dermatitis and psoriasis of the scalp. The sample will be at convenience. The files of the patients who have received treatment with Sebryl® and / or Sebryl Plus® in the last 5 years (2016 to 2021) will be chosen.
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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: Allantoin / Coal Tar / Clioquinol (Sebryl®) | Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 5.0 g/ 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allantoin/ Coal Tar/ Clioquinol | Other | Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 5.0 g/ Clioquinol 3.0 g Administration way: For scalp use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of adverse events | Evaluate the presence or absence of adverse events reported in the clinical files. | Last 5 years |
| Classify adverse events | Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation | Last 5 years |
| Mean age in years | Describe the mean age in years of the patients included in the study. | Last 5 years |
| Describe study population by gender ratio | Describe the proportion of women and men included in the study | Last 5 years |
| Describe the body mass index through weight and heigh | Describe the body mass index of the study population calculated through weight and heigh of the patient and using the formula kilogram over square meter. | Last 5 years |
| Describe the blood pressure millimetres of mercury (mmHg) | Describe the blood pressure in mmHg of the patients included in the study. | Last 5 years |
| Mean heart rate in beats per minute | Describe the mean heart rate in beats per minute of the patients included in the study. | Last 5 years |
| Percentage of times use outside of expected indications |
| Measure | Description | Time Frame |
|---|---|---|
| Description of usage pattern according to prescribed dosage | Describe according to prescribed dosage the pattern of use of Sebryl® and / or Sebryl Plus® in the management of seborrheic dermatitis and psoriasis of the scalp. | Last 5 years |
| Description of usage pattern according to prescribed time |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects of indistinct sex with seborrheic dermatitis and / or psoriasis of the scalp who, according to medical criteria, have been candidates for treatment with Sebryl® and / or Sebryl Plus®.
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| Name | Affiliation | Role |
|---|---|---|
| María E Morales Barrera, M.D | Independent consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Silanes, S.A. de C.V. | Mexico City | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11422182 | Background | 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. | |
| 23014338 | Background | 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. |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Not provided
| ID | Term |
|---|---|
| D000481 | Allantoin |
| D003033 | Coal Tar |
| D007464 | Clioquinol |
| D014260 | Triclosan |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006827 | Hydantoins |
| D048289 |
Not provided
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|
| Allantoin/ Coal Tar/ Clioquinol/ Triclosan | Other | 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 |
|
|
Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications. |
| Last 5 years |
Describe according to prescribed time the pattern of use of Sebryl® and / or Sebryl Plus® in the management of seborrheic dermatitis and psoriasis of the scalp. |
| Last 5 years |
| 8876289 | Background | 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. |
| 24388724 | Background | 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. |
| 23374051 | Background | 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. |
| 30909615 | Background | Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475. |
| 19614856 | Background | 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. |
| 19641206 | Background | 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. |
| 17021763 | Background | 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. |
| 27221798 | Background | Gerdes S, Mrowietz U, Boehncke WH. [Comorbidity in psoriasis]. Hautarzt. 2016 Jun;67(6):438-44. doi: 10.1007/s00105-016-3805-3. German. |
| 11255325 | Background | 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. |
| 17615051 | Background | 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. |
| 10695585 | Background | 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. |
| 27148560 | Background | 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. |
| 6627992 | Background | 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. |
| 21159259 | Background | 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. |
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
| Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013638 | Tars |
| D045424 | Complex Mixtures |
| D015125 | Oxyquinoline |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |