Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp

Seborrheic Dermatitis Clinical Trial

Official title:

Retrospective Study to Evaluate the Safety of Sebryl® and / or Sebryl Plus® in the Treatment of Seborrheic Dermatitis and Psoriasis of the Scalp in Routine Medical Practice.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105139
• Other study ID #: SIL-31103-IV-21(1)
• Status: Completed
• Start date: November 29, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: April 2022
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 25, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Psoriasis
• Psoriasis of Scalp
• Seborrheic Dermatitis

Intervention

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
• 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

Locations

Country	Name	City	State
Mexico	Laboratorio Silanes, S.A. de C.V.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (16)

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. — View Citation

Christophers E. Psoriasis--epidemiology and clinical spectrum. Clin Exp Dermatol. 2001 Jun;26(4):314-20. Review. — View Citation

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. — View Citation

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. — View Citation

Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996 Sep;35(9):633-9. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rendon A, Schäkel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6). pii: E1475. doi: 10.3390/ijms20061475. Review. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of adverse events	Evaluate the presence or absence of adverse events reported in the clinical files.	Last 5 years
Primary	Classify adverse events	Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation	Last 5 years
Primary	Mean age in years	Describe the mean age in years of the patients included in the study.	Last 5 years
Primary	Describe study population by gender ratio	Describe the proportion of women and men included in the study	Last 5 years
Primary	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
Primary	Describe the blood pressure millimetres of mercury (mmHg)	Describe the blood pressure in mmHg of the patients included in the study.	Last 5 years
Primary	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
Primary	Percentage of times use outside of expected indications	Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications.	Last 5 years
Secondary	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
Secondary	Description of usage pattern according to prescribed time	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