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

Study Overview
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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®.

Official Title
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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.

Conditions
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Seborrheic Dermatitis, Psoriasis of Scalp

Intervention / Treatment
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* Other: Allantoin/ Coal Tar/ Clioquinol
* Other: Allantoin/ Coal Tar/ Clioquinol/ Triclosan


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A1: Allantoin / Coal Tar / Clioquinol (Sebryl®)<br>Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 5.0 g/ 3.0 g Administration way: For scalp use | Other: Allantoin/ Coal Tar/ Clioquinol<br>* Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 5.0 g/ Clioquinol 3.0 g Administration way: For scalp use<br>* Other names: Sebryl®;|
| A2: Allantoin/ Coal Tar/ Clioquinol/ Triclosan (Sebryl Plus®)<br>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<br>* 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<br>* Other names: Sebryl Plus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of usage pattern according to prescribed dosage | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allantoin, Coal Tar, Clioquinol, Triclosan, Seborrheic Dermatitis, Psoriasis of Scalp