Management of Stable VitiligoNCT06370650
Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study
A study testing platelet rich plasma, narrow band UVB in people with Management of Stable Vitiligo, run by Sohag University at 1 site in Egypt.
Trial summary
For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Management of Stable Vitiligo
- What is being tested?
- platelet rich plasma, narrow band UVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Dec 2023to 30 Jun 2024
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with stable non segmental vitiligo. (Absence of koebnerization, absence of new lesion and absence of widening of the existing lesions).
- Patients have more than 15 years.
- -
Who cannot join
- Patients have active vitiligo (appearance of new lesion, history of koebnerization).
- Pregnant and lactating women. History of keloid formation. Anemia (hemoglobin level <10gm/dl), thrombocytopenia (platelet count <100,000 /µL), coagulopathies or patients on anticoagulant therapy and patients with iron deficiency.
- Patients taking drugs that prolong bleeding time such as Aspirin and vitamin E Patients taking treatment of vitiligo in last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed.
- Conditions
- Management of Stable Vitiligo
- Being tested
- platelet rich plasma, narrow band UVB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma, narrow band UVBProcedure or surgery
Role of PRP in treating stable vitiligo
| Study group | Role | What they receive |
|---|---|---|
| Narrow band UVB | Active comparator | Not described Receives: Procedure: platelet rich plasma, narrow band UVB |
| Platelet rich plasma plus narrow band UVB | Active comparator | Not described Receives: Procedure: platelet rich plasma, narrow band UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of vitiligo
increase repigmentation score
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start8 Dec 2023
- Primary completion25 Jan 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Stable VitiligoStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hassan Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370650
- Sponsor's protocol ID
- soh-med-24-1-9
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researcher shall pubish in national journal
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study
- ClinicalTrials.gov ID
- NCT06370650
- Acronym / sponsor ID
- soh-med-24-1-9
- Conditions
- Management of Stable Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Apr 2024 (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.
For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow band UVB | Active comparator | Procedure: platelet rich plasma, narrow band UVB |
| Platelet rich plasma plus narrow band UVB | Active comparator | Procedure: platelet rich plasma, narrow band UVB |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with stable non segmental vitiligo. (Absence of koebnerization, absence of new lesion and absence of widening of the existing lesions).
- Patients have more than 15 years.
- -
Key exclusion criteria (3 listed)
- Patients have active vitiligo (appearance of new lesion, history of koebnerization).
- Pregnant and lactating women. History of keloid formation. Anemia (hemoglobin level <10gm/dl), thrombocytopenia (platelet count <100,000 /µL), coagulopathies or patients on anticoagulant therapy and patients with iron deficiency.
- Patients taking drugs that prolong bleeding time such as Aspirin and vitamin E Patients taking treatment of vitiligo in last 2 months
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 |
|---|---|---|
| platelet rich plasma, narrow band UVBRole of PRP in treating stable vitiligo | Procedure or surgery | Narrow band UVB, Platelet rich plasma plus narrow band UVB |
Primary outcome
Improvement of vitiligo
Time frame: within 6 months
increase repigmentation score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided. Researcher shall pubish in national journal
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma, narrow band UVB in people with Management of Stable Vitiligo, run by Sohag 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 17 Apr 2024. 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?
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?
Improvement of vitiligo (time frame: within 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 17 Apr 2024.