VitiligoNCT05335746
Ocular Changes in Vitiligo Patients on Therapy
An observational study of Vitiligo and Chorioretinopathy, run by Benha University at 1 site in Egypt.
Trial summary
Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitiligo, Chorioretinopathy, Chorioretinitis
- What is being tested?
- Optical coherence tomography angiography (OCT-A)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to 30 Sep 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Dermatology and ophthalmology clinics at banha university.
Who may be able to join
- vitiligo patients on systemic and local therapy that regularly visit dermatology clinic at banha university.
- normal subjects seeking regular ophthalmic examination at ophthalmology clinic at banha university.
Who cannot join
- patients with known chronic retinal diseases that may alter OCT-A parameters as age related macular degeneration and diabetic retinopathies.
- patients that refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha University
Banhā, QA, 13511
Ahmed Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
Amal Yousif, 01008128810, amalderma@gmail.com
About this study
Official title: Chorioretinal Changes in Vitiligo Patients on Therapy
Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.
Read the detailed description
Chorioretinal changes associated with vitiligo therapy could address patients visual acuity and life style. Early detection of these changes can help these patients to evade such adverse effects.
- Conditions
- Vitiligo, Chorioretinopathy, Chorioretinitis
- Being tested
- Optical coherence tomography angiography (OCT-A)
- Keywords
- Vitiligo, Chorioretinitis
- Medical subject headings
- Vitiligo, Chorioretinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiography (OCT-A)Diagnostic test
Also called OCT-A
Optical coherence tomography angiography scanning will be done for all subjects in the study.
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo patients on therapy | Patients diagnosed as vitiligo and on systemic and local therapy. Receives: Diagnostic Test: Optical coherence tomography angiography (OCT-A) | |
| Control group | Normal subjects recruited from ophthalmology clinic and visit the clinic for regular check-up. Receives: Diagnostic Test: Optical coherence tomography angiography (OCT-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vessel density (VD) in superficial and deep retinal layer.
Percentage (%) of superficial and deep vessel density changes in both groups measured by OCT-A software to asses retinal ischemia.
Measured: Immediately after OCT-A for each eye and at one month of follow-up.
Secondary outcomes (1)
Foveal avascular zone (FAZ) in millimeter (mm).
Foveal avascular zone measurement in both groups in mm measured by OCT-A software.
Measured: Immediately after OCT-A for each eye and at one month of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start10 Mar 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Amal A Yousif, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335746
- Sponsor's protocol ID
- Rc 6-2022
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chorioretinal Changes in Vitiligo Patients on Therapy
- ClinicalTrials.gov ID
- NCT05335746
- Acronym / sponsor ID
- Rc 6-2022
- Conditions
- Vitiligo, Chorioretinopathy, Chorioretinitis
- Keywords
- Vitiligo, Chorioretinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 Apr 2022 (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.
Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.
Detailed description
Chorioretinal changes associated with vitiligo therapy could address patients visual acuity and life style. Early detection of these changes can help these patients to evade such adverse effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo patients on therapy | – | Diagnostic Test: Optical coherence tomography angiography (OCT-A)Patients diagnosed as vitiligo and on systemic and local therapy. |
| Control group | – | Diagnostic Test: Optical coherence tomography angiography (OCT-A)Normal subjects recruited from ophthalmology clinic and visit the clinic for regular check-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Dermatology and ophthalmology clinics at banha university.
Key inclusion criteria (2 listed)
- vitiligo patients on systemic and local therapy that regularly visit dermatology clinic at banha university.
- normal subjects seeking regular ophthalmic examination at ophthalmology clinic at banha university.
Key exclusion criteria (2 listed)
- patients with known chronic retinal diseases that may alter OCT-A parameters as age related macular degeneration and diabetic retinopathies.
- patients that refuse to participate in this 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 |
|---|---|---|
| Optical coherence tomography angiography (OCT-A)Also: OCT-AOptical coherence tomography angiography scanning will be done for all subjects in the study. | Diagnostic test | Control group, Vitiligo patients on therapy |
Primary outcome
Percentage of vessel density (VD) in superficial and deep retinal layer.
Time frame: Immediately after OCT-A for each eye and at one month of follow-up.
Percentage (%) of superficial and deep vessel density changes in both groups measured by OCT-A software to asses retinal ischemia.
1 secondary outcome
Foveal avascular zone (FAZ) in millimeter (mm).
Time frame: Immediately after OCT-A for each eye and at one month of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
Amal A Yousif, MD principal investigator
Benha University
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 Vitiligo and Chorioretinopathy, run by Benha 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 2 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 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 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 Ahmed Abdelshafy, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of vessel density (VD) in superficial and deep retinal layer. (time frame: Immediately after OCT-A for each eye and at one month of follow-up.). 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 Apr 2022.