Recurrent Pityriasis VersicolorNCT04769804
Gene Polymorphism in Tinea Versicolor
An observational study of Recurrent Pityriasis Versicolor, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F. In addition , serum samples from patients and controls will be tested for 25(OH)2 D3 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recurrent Pityriasis Versicolor
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 1 Nov 2021
- 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 18 to 60 years
- All sexes
- Adult
Study population: Patients with history of disseminated TV, with 2 or more episodes of TV per year.
Who may be able to join
- - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it.
- Patients of both genders.
- Age ≥18 years old.
Who cannot join
- - Patients with other cutaneous diseases.
- Patient's having dandruff (scaly scalp) even if not symptomatizing.
- Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects.
- Patients with autoimmune diseases.
- Patients with immunodeficiency diseases.
- Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy Hospital, Cairo university
Cairo, El Manial, 11956
Rana Hilal, MD, 01001488869 ext. +20, rana.hilal@kasralainy.edu.eg
About this study
Official title: Detection of IL1-7A and IL-17F Gene Polymorphism in Pityriasis Versicolor and Its Relation to Susceptibility to Infections.
Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F.
In addition , serum samples from patients and controls will be tested for 25(OH)2 D3
- Conditions
- Recurrent Pityriasis Versicolor
- Medical subject headings
- Tinea Versicolor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent pityriasis versicolor | Not described | |
| Healthy age and sex-matched controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL 17A gene polymorphism
IL 17A
Measured: 6months-1 year
IL 17 F gene polymorphism
IL 17 F
Measured: 6months-1 year
Secondary outcomes (1)
Vitamin D
Serum 25(OH)2 D3
Measured: 6months-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Nov 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pityriasis VersicolorStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769804
- Sponsor's protocol ID
- PolymorphismTV
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of IL1-7A and IL-17F Gene Polymorphism in Pityriasis Versicolor and Its Relation to Susceptibility to Infections.
- ClinicalTrials.gov ID
- NCT04769804
- Acronym / sponsor ID
- PolymorphismTV
- Conditions
- Recurrent Pityriasis Versicolor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 25 Feb 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.
Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F.
In addition , serum samples from patients and controls will be tested for 25(OH)2 D3
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent pityriasis versicolor | – | – |
| Healthy age and sex-matched controls | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with history of disseminated TV, with 2 or more episodes of TV per year.
Key inclusion criteria (3 listed)
- - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it.
- Patients of both genders.
- Age ≥18 years old.
Key exclusion criteria (6 listed)
- - Patients with other cutaneous diseases.
- Patient's having dandruff (scaly scalp) even if not symptomatizing.
- Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects.
- Patients with autoimmune diseases.
- Patients with immunodeficiency diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL 17A gene polymorphism
Time frame: 6months-1 year
IL 17A
IL 17 F gene polymorphism
Time frame: 6months-1 year
IL 17 F
1 secondary outcome
Vitamin D
Time frame: 6months-1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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.
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 Recurrent Pityriasis Versicolor, run by Kasr El Aini Hospital at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Hilal, MD (01001488869 ext. +20, rana.hilal@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL 17A gene polymorphism (time frame: 6months-1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.