Seborrheic DermatitisNCT05105139
Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
An observational study of Seborrheic Dermatitis and Psoriasis of Scalp, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Dermatitis, Psoriasis of Scalp
- What is being tested?
- Allantoin/ Coal Tar/ Clioquinol and Allantoin/ Coal Tar/ Clioquinol/ Triclosan
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- 29 Nov 2021to 25 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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®.
Who may be able to join
- 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
Who cannot join
- That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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®.
- Conditions
- Seborrheic Dermatitis, Psoriasis of Scalp
- Being tested
- Allantoin/ Coal Tar/ Clioquinol, Allantoin/ Coal Tar/ Clioquinol/ Triclosan
- Keywords
- Allantoin, Coal Tar, Clioquinol, Triclosan, Seborrheic Dermatitis, Psoriasis of Scalp
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allantoin/ Coal Tar/ ClioquinolOther
Also called Sebryl®
Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 5.0 g/ Clioquinol 3.0 g Administration way: For scalp use
Allantoin/ Coal Tar/ Clioquinol/ TriclosanOther
Also called Sebryl Plus®
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
| Study group | Role | What they receive |
|---|---|---|
| A1: Allantoin / Coal Tar / Clioquinol (Sebryl®) | Pharmaceutical Form: Shampoo Dosage: 0.2 g/ 5.0 g/ 3.0 g Administration way: For scalp use Receives: Other: Allantoin/ Coal Tar/ Clioquinol | |
| 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 Receives: Other: Allantoin/ Coal Tar/ Clioquinol/ Triclosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adverse events
Evaluate the presence or absence of adverse events reported in the clinical files.
Measured: Last 5 years
Classify adverse events
Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation
Measured: Last 5 years
Mean age in years
Describe the mean age in years of the patients included in the study.
Measured: Last 5 years
Describe study population by gender ratio
Describe the proportion of women and men included in the study
Measured: 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.
Measured: Last 5 years
Describe the blood pressure millimetres of mercury (mmHg)
Describe the blood pressure in mmHg of the patients included in the study.
Measured: 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.
Measured: 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.
Measured: Last 5 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: Last 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start29 Nov 2021
- Primary completion15 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María E Morales Barrera, M.D, Principal investigator, Independent consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105139
- Sponsor's protocol ID
- SIL-31103-IV-21(1)
- Status last verified
- Apr 2022
- First submitted
- 12 Oct 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christophers E. Psoriasis--epidemiology and clinical spectrum. Clin Exp Dermatol. 2001 Jun;26(4):314-20. doi: 10.1046/j.1365-2230.2001.00832.x.
PubMed 11422182Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
PubMed 23014338Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996 Sep;35(9):633-9. doi: 10.1111/j.1365-4362.1996.tb03687.x.
PubMed 8876289Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014 Mar;70(3):512-6. doi: 10.1016/j.jaad.2013.11.013. Epub 2014 Jan 2.
PubMed 24388724Danielsen K, Olsen AO, Wilsgaard T, Furberg AS. Is the prevalence of psoriasis increasing? A 30-year follow-up of a population-based cohort. Br J Dermatol. 2013 Jun;168(6):1303-10. doi: 10.1111/bjd.12230.
PubMed 23374051Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
PubMed 30909615Ortonne J, Chimenti S, Luger T, Puig L, Reid F, Trueb RM. Scalp psoriasis: European consensus on grading and treatment algorithm. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1435-44. doi: 10.1111/j.1468-3083.2009.03372.x. Epub 2009 Jul 15.
PubMed 19614856Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
PubMed 19641206Sommer DM, Jenisch S, Suchan M, Christophers E, Weichenthal M. Increased prevalence of the metabolic syndrome in patients with moderate to severe psoriasis. Arch Dermatol Res. 2006 Dec;298(7):321-8. doi: 10.1007/s00403-006-0703-z. Epub 2006 Sep 22.
PubMed 17021763Gerdes S, Mrowietz U, Boehncke WH. [Comorbidity in psoriasis]. Hautarzt. 2016 Jun;67(6):438-44. doi: 10.1007/s00105-016-3805-3. German.
PubMed 27221798Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001 Mar;137(3):280-4.
PubMed 11255325Nast A, Kopp IB, Augustin M, Banditt KB, Boehncke WH, Follmann M, Friedrich M, Huber M, Kahl C, Klaus J, Koza J, Kreiselmaier I, Mohr J, Mrowietz U, Ockenfels HM, Orzechowski HD, Prinz J, Reich K, Rosenbach T, Rosumeck S, Schlaeger M, Schmid-Ott G, Sebastian M, Streit V, Weberschock T, Rzany B; Deutsche Dermatologische Gesellschaft (DDG); Berufsverband Deutscher Dermatologen (BVDD). Evidence-based (S3) guidelines for the treatment of psoriasis vulgaris. J Dtsch Dermatol Ges. 2007 Jul;5 Suppl 3:1-119. doi: 10.1111/j.1610-0387.2007.06172.x.
PubMed 17615051Pardasani AG, Feldman SR, Clark AR. Treatment of psoriasis: an algorithm-based approach for primary care physicians. Am Fam Physician. 2000 Feb 1;61(3):725-33, 736.
PubMed 10695585Borda LJ, Wikramanayake TC. Seborrheic Dermatitis and Dandruff: A Comprehensive Review. J Clin Investig Dermatol. 2015 Dec;3(2):10.13188/2373-1044.1000019. doi: 10.13188/2373-1044.1000019. Epub 2015 Dec 15.
PubMed 27148560Langner A, Wolska H, Hebborn P. Treatment of psoriasis of the scalp with coal tar gel and shampoo preparations. Cutis. 1983 Sep;32(3):290-1, 295-6.
PubMed 6627992
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05105139
- Acronym / sponsor ID
- SIL-31103-IV-21(1)
- Conditions
- Seborrheic Dermatitis, Psoriasis of Scalp
- Keywords
- Allantoin, Coal Tar, Clioquinol, Triclosan, Seborrheic Dermatitis, Psoriasis of Scalp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1: Allantoin / Coal Tar / Clioquinol (Sebryl®) | – | Other: Allantoin/ Coal Tar/ ClioquinolPharmaceutical 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®) | – | Other: Allantoin/ Coal Tar/ Clioquinol/ TriclosanPharmaceutical Form: Shampoo Dosage: 0.2 g/ 3.0 g/ 3.0 g/ 0.3 g Administration way: For scalp use |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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®.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allantoin/ Coal Tar/ ClioquinolAlso: Sebryl®Pharmaceutical Form: Shampoo Dosage: Allantoin 0.2 g/ Coal Tar 5.0 g/ Clioquinol 3.0 g Administration way: For scalp use | Other | A1: Allantoin / Coal Tar / Clioquinol (Sebryl®) |
| Allantoin/ Coal Tar/ Clioquinol/ TriclosanAlso: Sebryl Plus®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 | A2: Allantoin/ Coal Tar/ Clioquinol/ Triclosan (Sebryl Plus®) |
Primary outcome
Proportion of adverse events
Time frame: Last 5 years
Evaluate the presence or absence of adverse events reported in the clinical files.
Classify adverse events
Time frame: Last 5 years
Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation
Mean age in years
Time frame: Last 5 years
Describe the mean age in years of the patients included in the study.
Describe study population by gender ratio
Time frame: Last 5 years
Describe the proportion of women and men included in the study
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.
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.
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.
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.
2 secondary outcomes
Description of usage pattern according to prescribed dosage
Time frame: Last 5 years
Description of usage pattern according to prescribed time
Time frame: Last 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 11422182Christophers E. Psoriasis--epidemiology and clinical spectrum. Clin Exp Dermatol. 2001 Jun;26(4):314-20. doi: 10.1046/j.1365-2230.2001.00832.x.
- Background: PubMed 23014338Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
- Background: PubMed 8876289Gibbs S. Skin disease and socioeconomic conditions in rural Africa: Tanzania. Int J Dermatol. 1996 Sep;35(9):633-9. doi: 10.1111/j.1365-4362.1996.tb03687.x.
- Background: PubMed 24388724Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014 Mar;70(3):512-6. doi: 10.1016/j.jaad.2013.11.013. Epub 2014 Jan 2.
- Background: PubMed 23374051Danielsen K, Olsen AO, Wilsgaard T, Furberg AS. Is the prevalence of psoriasis increasing? A 30-year follow-up of a population-based cohort. Br J Dermatol. 2013 Jun;168(6):1303-10. doi: 10.1111/bjd.12230.
- Background: PubMed 30909615Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
- Background: PubMed 19614856Ortonne J, Chimenti S, Luger T, Puig L, Reid F, Trueb RM. Scalp psoriasis: European consensus on grading and treatment algorithm. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1435-44. doi: 10.1111/j.1468-3083.2009.03372.x. Epub 2009 Jul 15.
- Background: PubMed 19641206Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
- Background: PubMed 17021763Sommer DM, Jenisch S, Suchan M, Christophers E, Weichenthal M. Increased prevalence of the metabolic syndrome in patients with moderate to severe psoriasis. Arch Dermatol Res. 2006 Dec;298(7):321-8. doi: 10.1007/s00403-006-0703-z. Epub 2006 Sep 22.
- Background: PubMed 27221798Gerdes S, Mrowietz U, Boehncke WH. [Comorbidity in psoriasis]. Hautarzt. 2016 Jun;67(6):438-44. doi: 10.1007/s00105-016-3805-3. German.
- Background: PubMed 11255325Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001 Mar;137(3):280-4.
- Background: PubMed 17615051Nast A, Kopp IB, Augustin M, Banditt KB, Boehncke WH, Follmann M, Friedrich M, Huber M, Kahl C, Klaus J, Koza J, Kreiselmaier I, Mohr J, Mrowietz U, Ockenfels HM, Orzechowski HD, Prinz J, Reich K, Rosenbach T, Rosumeck S, Schlaeger M, Schmid-Ott G, Sebastian M, Streit V, Weberschock T, Rzany B; Deutsche Dermatologische Gesellschaft (DDG); Berufsverband Deutscher Dermatologen (BVDD). Evidence-based (S3) guidelines for the treatment of psoriasis vulgaris. J Dtsch Dermatol Ges. 2007 Jul;5 Suppl 3:1-119. doi: 10.1111/j.1610-0387.2007.06172.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María E Morales Barrera, M.D principal investigator
Independent consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seborrheic Dermatitis and Psoriasis of Scalp, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adverse events (time frame: Last 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105139, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.