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

NCT05105139 | Completed

• 1 other identifier: SIL-31103-IV-21(1)
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Dermatitis; Psoriasis of Scalp

Keywords

Allantoin; Coal Tar; Clioquinol; Triclosan; Seborrheic Dermatitis; Psoriasis of Scalp

Outcome Measures

Primary Outcomes (8)

• 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

  Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications.

  Last 5 years

Secondary Outcomes (2)

• Description of usage pattern according to prescribed dosage

  Last 5 years

• Description of usage pattern according to prescribed time

  Last 5 years

Study Arms (2)

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

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

Interventions

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

Also known as: Sebryl®

A1: Allantoin / Coal Tar / Clioquinol (Sebryl®)

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

Also known as: Sebryl Plus®

A2: Allantoin/ Coal Tar/ Clioquinol/ Triclosan (Sebryl Plus®)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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®.

You may qualify if:

• 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

You may not qualify if:

• That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

Location

Related Publications (16)

• 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.

  PMID: 11422182 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.

  PMID: 23014338 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.

  PMID: 8876289 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.

  PMID: 24388724 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.

  PMID: 23374051 BACKGROUND

• Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.

  PMID: 30909615 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.

  PMID: 19614856 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.

  PMID: 19641206 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.

  PMID: 17021763 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.

  PMID: 27221798 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.

  PMID: 11255325 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.

  PMID: 17615051 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.

  PMID: 10695585 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.

  PMID: 27148560 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.

  PMID: 6627992 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.

  PMID: 21159259 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Seborrheic

Interventions

Allantoin; Coal Tar; Clioquinol; Triclosan

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tars; Complex Mixtures; Oxyquinoline; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• María E Morales Barrera, M.D

  Independent consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 3, 2021
• Study Start: November 29, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 25, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)