Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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®.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| A1: Allantoin / Coal Tar / Clioquinol (Sebryl®) Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 5.0 g/ 3.0 g Administration way: For scalp use |
Other: 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
Other Names:
|
| 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 |
Other: 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of adverse events [Last 5 years]
Evaluate the presence or absence of adverse events reported in the clinical files.
- Classify adverse events [Last 5 years]
Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation
- Mean age in years [Last 5 years]
Describe the mean age in years of the patients included in the study.
- Describe study population by gender ratio [Last 5 years]
Describe the proportion of women and men included in the study
- Describe the body mass index through weight and heigh [Last 5 years]
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.
- Describe the blood pressure millimetres of mercury (mmHg) [Last 5 years]
Describe the blood pressure in mmHg of the patients included in the study.
- Mean heart rate in beats per minute [Last 5 years]
Describe the mean heart rate in beats per minute of the patients included in the study.
- Percentage of times use outside of expected indications [Last 5 years]
Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications.
Secondary Outcome Measures
- Description of usage pattern according to prescribed dosage [Last 5 years]
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.
- Description of usage pattern according to prescribed time [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Any sex.
-
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:
- That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratorio Silanes, S.A. de C.V. | Mexico City | Mexico | 11000 |
Sponsors and Collaborators
- Laboratorios Silanes S.A. de C.V.
Investigators
- Principal Investigator: María E Morales Barrera, M.D, Independent consultant
Study Documents (Full-Text)
None provided.More Information
Publications
- Borda LJ, Wikramanayake TC. Seborrheic Dermatitis and Dandruff: A Comprehensive Review. J Clin Investig Dermatol. 2015 Dec;3(2). doi: 10.13188/2373-1044.1000019. Epub 2015 Dec 15.
- Christophers E. Psoriasis--epidemiology and clinical spectrum. Clin Exp Dermatol. 2001 Jun;26(4):314-20. Review.
- 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.
- Gerdes S, Mrowietz U, Boehncke WH. [Comorbidity in psoriasis]. Hautarzt. 2016 Jun;67(6):438-44. doi: 10.1007/s00105-016-3805-3. Review. German.
- Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996 Sep;35(9):633-9. Review.
- 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.
- 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.
- 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.
- Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. Review.
- Ortonne J, Chimenti S, Luger T, Puig L, Reid F, Trüeb 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.
- 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. Review.
- 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. Review.
- Puig L, Ribera M, Hernanz JM, Belinchón I, Santos-Juanes J, Linares M, Querol I, Colomé E, Caballé 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. Review. Spanish.
- 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.
- Rendon A, Schäkel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6). pii: E1475. doi: 10.3390/ijms20061475. Review.
- 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. Epub 2006 Sep 22.
- SIL-31103-IV-21(1)