Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
- Conditions
- Seborrheic DermatitisPsoriasis of Scalp
- Interventions
- Other: Allantoin/ Coal Tar/ ClioquinolOther: Allantoin/ Coal Tar/ Clioquinol/ Triclosan
- Registration Number
- NCT05105139
- Lead Sponsor
- Laboratorios Silanes S.A. de C.V.
- 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.
- 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®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A1: Allantoin / Coal Tar / Clioquinol (Sebryl®) Allantoin/ Coal Tar/ Clioquinol Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 5.0 g/ 3.0 g Administration way: For scalp use A2: Allantoin/ Coal Tar/ Clioquinol/ Triclosan (Sebryl Plus®) Allantoin/ Coal Tar/ Clioquinol/ Triclosan Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 3.0 g/ 3.0 g/ 0.3 g Administration way: For scalp use
- Primary Outcome Measures
Name Time Method Classify adverse events Last 5 years Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation
Describe study population by gender ratio Last 5 years Describe the proportion of women and men included in the study
Proportion of adverse events Last 5 years Evaluate the presence or absence of adverse events reported in the clinical files.
Mean age in years Last 5 years Describe the mean age in years of the patients included in the study.
Describe the body mass index through weight and heigh 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.
Mean heart rate in beats per minute Last 5 years Describe the mean heart rate in beats per minute of the patients included in the study.
Describe the blood pressure millimetres of mercury (mmHg) Last 5 years Describe the blood pressure in mmHg of the patients included in the study.
Percentage of times use outside of expected indications Last 5 years Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications.
- Secondary Outcome Measures
Name Time Method Description of usage pattern according to prescribed time 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.
Description of usage pattern according to prescribed dosage 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.
Trial Locations
- Locations (1)
Laboratorio Silanes, S.A. de C.V.
🇲🇽Mexico City, Mexico