Clinical trial NCT05105139: Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seborrheic Dermatitis
Psoriasis of Scalp
Keywords: Allantoin
Coal Tar
Clioquinol
Triclosan
Seborrheic Dermatitis
Psoriasis of Scalp
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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®.

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®.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of adverse events
timeFrame: Last 5 years
measure: Classify adverse events
timeFrame: Last 5 years
measure: Mean age in years
timeFrame: Last 5 years
measure: Describe study population by gender ratio
timeFrame: Last 5 years
measure: Describe the body mass index through weight and heigh
timeFrame: Last 5 years
measure: Describe the blood pressure millimetres of mercury (mmHg)
timeFrame: Last 5 years
measure: Mean heart rate in beats per minute
timeFrame: Last 5 years
measure: Percentage of times use outside of expected indications
timeFrame: Last 5 years
Secondary outcomes:
measure: Description of usage pattern according to prescribed dosage
timeFrame: Last 5 years
measure: Description of usage pattern according to prescribed time
timeFrame: Last 5 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Independent consultant
name: María E Morales Barrera, M.D
role: PRINCIPAL_INVESTIGATOR
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