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NCT Number: NCT05105139

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

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.

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Key information

Conditions

Seborrheic Dermatitis Dermatitis Dermatitis, Seborrheic Psoriasis of Scalp Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Mexico City, 11000, Mexico

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: 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

Other names: Sebryl Plus®

Primary outcomes

  1. Proportion of adverse events

    Time frame: Last 5 years

    Evaluate the presence or absence of adverse events reported in the clinical files.

  2. Classify adverse events

    Time frame: Last 5 years

    Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation

  3. Mean age in years

    Time frame: Last 5 years

    Describe the mean age in years of the patients included in the study.

  4. Describe study population by gender ratio

    Time frame: Last 5 years

    Describe the proportion of women and men included in the study

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2021
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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