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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-02-25

Brief Summary

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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.

Detailed Description

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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®.

Conditions

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Seborrheic Dermatitis Psoriasis of Scalp

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type 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

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Sebryl® Sebryl Plus®

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratorios Silanes S.A. de C.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Mexico

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.

Reference Type BACKGROUND
PMID: 11422182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23014338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8876289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24388724 (View on PubMed)

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.

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

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 19614856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19641206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17021763 (View on PubMed)

Gerdes S, Mrowietz U, Boehncke WH. [Comorbidity in psoriasis]. Hautarzt. 2016 Jun;67(6):438-44. doi: 10.1007/s00105-016-3805-3. German.

Reference Type BACKGROUND
PMID: 27221798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11255325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17615051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10695585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27148560 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6627992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21159259 (View on PubMed)

Other Identifiers

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SIL-31103-IV-21(1)

Identifier Type: -

Identifier Source: org_study_id

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