Erythroid Differentiation Regulator 1 (Erdr1) CytokineNCT03377998
Expression of Erythroid Differentiation Regulator 1 (Erdr1) in Vitiligo
A study testing skin biopsy in people with Erythroid Differentiation Regulator 1 (Erdr1) Cytokine, run by Cairo University.
Trial summary
Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythroid Differentiation Regulator 1 (Erdr1) Cytokine
- What is being tested?
- skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jul 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with generalized non-segmental vitiligo.
- Both sexes.
- Age >18 years old.
- New cases or cases not receiving any medication for at least 3 months ago.
Who cannot join
- Segmental or Universal vitiligo
- Autoimmune diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expression of Erythroid Differentiation Regulator 1 (Erdr1) Cytokine in the Vitiliginous Skin Lesions: a Case Control Study
Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo
- Being tested
- skin biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.
| Study group | Role | What they receive |
|---|---|---|
| vitiligo patients | Experimental | lesional skin biopsy to measure ERDR1 level Receives: Other: skin biopsy |
| controls | Experimental | normal skin biopsy to measure ERDR1 level Receives: Other: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo and comparing its level in normal subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study startJan 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythroid Differentiation Regulator 1 (Erdr1) CytokineStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Fathy Elmasry, Cairo University
- Investigators
- Maha Elmasry, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377998
- Sponsor's protocol ID
- Dermatology 4
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 19 Dec 2017
- 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 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Erythroid Differentiation Regulator 1 (Erdr1) Cytokine in the Vitiliginous Skin Lesions: a Case Control Study
- ClinicalTrials.gov ID
- NCT03377998
- Acronym / sponsor ID
- Dermatology 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Dec 2017 (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.
Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitiligo patients | Experimental | Other: skin biopsylesional skin biopsy to measure ERDR1 level |
| controls | Experimental | Other: skin biopsynormal skin biopsy to measure ERDR1 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with generalized non-segmental vitiligo.
- Both sexes.
- Age >18 years old.
- New cases or cases not receiving any medication for at least 3 months ago.
Key exclusion criteria (2 listed)
- Segmental or Universal vitiligo
- Autoimmune diseases
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 |
|---|---|---|
| skin biopsySkin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls. | Other | controls, vitiligo patients |
Primary outcome
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo
Time frame: 6 months
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo and comparing its level in normal subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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.
Maha Elmasry, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Erythroid Differentiation Regulator 1 (Erdr1) Cytokine, run by Cairo University.
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 4 inclusion and 2 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Maha Fathy Elmasry, MD (00201222633740, mahafathy1214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo (time frame: 6 months). 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 19 Dec 2017; AzTrials last refreshed its copy on 6 Nov 2026.