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

April 12, 2022 updated by: Laboratorios Silanes S.A. de C.V.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Laboratorio Silanes, S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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®.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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:
  • Sebryl®
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:
  • Sebryl Plus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of adverse events
Time Frame: Last 5 years
Evaluate the presence or absence of adverse events reported in the clinical files.
Last 5 years
Classify adverse events
Time Frame: Last 5 years
Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation
Last 5 years
Mean age in years
Time Frame: Last 5 years
Describe the mean age in years of the patients included in the study.
Last 5 years
Describe study population by gender ratio
Time Frame: Last 5 years
Describe the proportion of women and men included in the study
Last 5 years
Describe the body mass index through weight and heigh
Time Frame: 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.
Last 5 years
Describe the blood pressure millimetres of mercury (mmHg)
Time Frame: Last 5 years
Describe the blood pressure in mmHg of the patients included in the study.
Last 5 years
Mean heart rate in beats per minute
Time Frame: Last 5 years
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
Time Frame: Last 5 years
Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications.
Last 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of usage pattern according to prescribed dosage
Time Frame: 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.
Last 5 years
Description of usage pattern according to prescribed time
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: María E Morales Barrera, M.D, Independent consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-31103-IV-21(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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