AutophagyNCT03371758
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo
A study testing skin biopsy in people with Autophagy, run by Cairo University at 1 site in Egypt.
Trial summary
The exact mechanism of impairment of autophagy in vitiligo has not yet been determined. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autophagy
- What is being tested?
- skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to May 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Patients with non-segmental vitiligo whether active or stable.
- Age above 12 years.
- Both sexes.
Who cannot join
- • Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.
- Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.
- Pregnancy or breast feeding for female patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Maha Fathy Elmasry
Cairo
Maha Fathy Elmasry, MD, mahafathy1214@gmail.com
About this study
Official title: Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo and Healthy Control; Comparative Study
The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.
- Conditions
- Autophagy
- 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
Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.
| Study group | Role | What they receive |
|---|---|---|
| vitiligo patients | Experimental | Not described Receives: Other: skin biopsy |
| healthy controls | Experimental | Not described Receives: Other: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startJan 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutophagyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Fathy Elmasry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371758
- Sponsor's protocol ID
- Dermatology
- Status last verified
- Jan 2018
- First submitted
- 5 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo and Healthy Control; Comparative Study
- ClinicalTrials.gov ID
- NCT03371758
- Acronym / sponsor ID
- Dermatology
- Conditions
- Autophagy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 13 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.
The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitiligo patients | Experimental | Other: skin biopsy |
| healthy controls | Experimental | Other: skin biopsy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients with non-segmental vitiligo whether active or stable.
Key exclusion criteria (3 listed)
- • Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.
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 biopsyPunch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls. | Other | healthy controls, vitiligo patients |
Primary outcome
Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Autophagy, run by Cairo University 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 3 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 23 Jan 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients (time frame: 1 year). 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 23 Jan 2018.