VitiligoNCT05037981
Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo
An observational study of Vitiligo, run by Cairo University.
Trial summary
Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Vitiligo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2015to 20 Aug 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with active localized vitiligo
Who may be able to join
- Patients ≥ 6 years old of both genders
- Early onset vitiligo (˂6m duration)
- Body surface area (BSA) affected ≤2%
Who cannot join
- Patients who received any previous treatment for vitiligo
- Pregnant and lactating females
- Patients with other cutaneous or systemic autoimmune diseases
- Patients with contraindication to systemic corticosteroids
About this study
Official title: Evaluation of Early Systemic Stabilization Therapy on Recent Onset Localized Non-segmental Vitiligo
Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T cell population predisposing to future disease relapses. The aim of this study was to assess the ability of early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.
- Conditions
- Vitiligo
- Medical subject headings
- Vitiligo
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration needed to arrest of vitiligo activity
Time needed for vitiligo patients to stop developing new lesions of vitiligo
Measured: 6 months
Duration of maintaining vitiligo stability
Time before any new vitiligo lesions reappear
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start10 Oct 2015
- Primary completion10 Aug 2021
- Study completion20 Aug 2021
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Saadi, Cairo University
- Investigators
- Samia Esmat, MD, Principal investigator, Cairo UniversityRania Mogawer, MD, Principal investigator, Cairo UniversityDalia Bassiony, MD, Study director, Cairo UniversitySuzan Shalaby, MD, Study chair, Cairo UniversityRehab Hegazy, MD, Study chair, Cairo UniversityNanis Ragab, MD, Study chair, Cairo UniversitySarah Ibrahim, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037981
- Sponsor's protocol ID
- vit105
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing in published manuscript in a journal
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Systemic Stabilization Therapy on Recent Onset Localized Non-segmental Vitiligo
- ClinicalTrials.gov ID
- NCT05037981
- Acronym / sponsor ID
- vit105
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2015 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 8 Sep 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.
Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T cell population predisposing to future disease relapses. The aim of this study was to assess the ability of early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with active localized vitiligo
Key inclusion criteria (3 listed)
- Patients ≥ 6 years old of both genders
- Early onset vitiligo (˂6m duration)
- Body surface area (BSA) affected ≤2%
Key exclusion criteria (4 listed)
- Patients who received any previous treatment for vitiligo
- Pregnant and lactating females
- Patients with other cutaneous or systemic autoimmune diseases
- Patients with contraindication to systemic corticosteroids
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
Duration needed to arrest of vitiligo activity
Time frame: 6 months
Time needed for vitiligo patients to stop developing new lesions of vitiligo
Duration of maintaining vitiligo stability
Time frame: 5 years
Time before any new vitiligo lesions reappear
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 8 Sep 2021.
- Individual participant dataSharing planned: No. Sharing in published manuscript in a journal
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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.
Samia Esmat, MD principal investigator
Cairo University
Rania Mogawer, MD principal investigator
Cairo University
Dalia Bassiony, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, 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 3 inclusion and 4 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 8 Sep 2021. 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?
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?
Duration needed to arrest of vitiligo activity (time frame: 6 months). 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 8 Sep 2021.