VitiligoNCT06394349
Platelet-rich Plasma Intradermal Injection Combined With 308 nm Excimer Light for Treating Stable Acral Vitiligo
A study testing PRP+308nm and NS+308nm in people with Vitiligo, run by Yijian Zhu at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if platelet-rich plasma (PRP) works to treat acral stable vitiligo in adults. It will also learn about the safety of platelet-rich plasma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- PRP+308nm and NS+308nm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2023to 14 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-segmental vitiligo stable for more than half a year;
- At least 1 separate stable lesion on each of the dorsum of the right and left hands, proximal fingers, distal fingers and palms;
- The area of white spots is less than 10 % of the total body surface area and more than 1 % of the total body surface area;
- Those who have not received systemic treatment of vitiligo and phototherapy or related treatments within 1 month ≥ 1 year without significant efficacy;
- Voluntary signing of informed consent.
Who cannot join
- Pregnant and lactating women;
- Those who have used glucocorticoids or other immunosuppressants in the last 3 months;
- Suffering from haematological disorders such as coagulation abnormalities and thrombocytopoietic disorders;
- Those who are allergic to ultraviolet light and photosensitive treatment;
- Scar constitution;
- Those with current or previous history of skin cancer or family history of skin cancer;
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- Those with infectious diseases such as HIV, syphilis, hepatitis B or C;
- Those with other serious systemic diseases;
- Patients who, in the judgement of the investigator, are not suitable for inclusion in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Yijian Zhu, M.D., +8615921018163, jocelyn_zhu007@163.com
About this study
Official title: Platelet-rich Plasma Intradermal Injection in Addition to 308 nm Excimer Light in the Treatment of Stable Acral Vitiligo: A Prospective Randomized Placebo-controlled Study
The goal of this clinical trial is to learn if platelet-rich plasma (PRP) works to treat acral stable vitiligo in adults. It will also learn about the safety of platelet-rich plasma. The main questions it aims to answer are:
- Does PRP combined with 308 nm excimer phototherapy improve the efficacy compared to 308 nm excimer light alone in the treatment of vitiligo of the extremities?
- What medical problems do participants have when taking PRP intradermal injections?
Read more
Researchers will compare PRP to a placebo (a look-alike substance that contains no drug) to see if PRP works to treat acral vitiligo.
Participants will:
- Receive PRP intradermal injections once a month and 308 nm excimer phototherapy twice a week, or the same frequency of saline injections and phototherapy for 6 consecutive months
- Visit the clinic once every 1 month for evaluations
- Keep a diary of their symptoms or side effects during follow-up
Read the detailed description
Vitiligo is an acquired skin disorder characterized by depigmented macules, and one of the conventional treatment principles is to promote the differentiation of stem cells at the follicular bulge into melanocytes, but vitiligo of the extremities is clinically difficult to repigmentation and resistant to treatment due to its lack of hair follicles. Platelet-rich plasma (PRP) is a concentrated platelet plasma obtained by in vitro isolation of autologous whole blood, and its effect on repigmentation of vitiligo at the extremities and the potential mechanism remain unclear. The investigators investigated the efficacy of PRP on acral vitiligo by a single-center, prospective, self-controlled clinical study.
- Conditions
- Vitiligo
- Being tested
- PRP+308nm, NS+308nm
- Keywords
- Acral vitiligo, Platelet-rich plasma, 308 nm excimer light
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP+308nmCombination product
PRP+308nm
NS+308nmCombination product
NS+308nm
| Study group | Role | What they receive |
|---|---|---|
| PRP+308nm | Experimental | The observation group received PRP intradermal injections (0.5cm apart, 0.02ml injected) once a month and 308 nm excimer phototherapy twice a week for 6 consecutive months. Receives: Combination Product: PRP+308nm |
| NS+308nm | Placebo comparator | The control group received the same frequency of saline injections (0.5cm apart, 0.02ml injected) and phototherapy for 6 consecutive months. Receives: Combination Product: NS+308nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASI (vitiligo area severity index) score
The calculation of VASI (vitiligo area severity index) scores was performed by analysing standard photographs taken in the clinic at each specified follow-up time. The range is 0-100 and lower scores mean a better outcome.
Measured: up to 24 weeks
VASI improvement
VASI improvement rate = (VASI baseline - VASI follow-up) / VASI baseline × 100 %. The range is 0-100% and higher index means a better outcome.
Measured: up to 24 weeks
Side effect questionnaire and Dermatology Life Quality Index (DLQI)
The side effect questionnaire includes discomfort such as pain, itching, erythema, or allergic reactions. The dermatology life quality index (DLQI) range is 0-30 and higher scores mean a better outcome.
Measured: up to 24 weeks
Secondary outcomes (3)
Average pigmentation value, average erythema value
They are observed and calculated by Antera 3D.
Measured: up to 24 weeks
Pigment and erythema mode images
They are captured by Antera 3D.
Measured: up to 24 weeks
Repigmentation patterns
They are observed by Antera 3D.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start22 Feb 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion14 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yijian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yijian Zhu, Huashan Hospital
- Investigators
- Yijian Zhu, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394349
- Sponsor's protocol ID
- 2023M-013
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsaadany AE, El-Khalawany M, Elshahid AR, Seddeik Abdel-Hameed AK. Comparison between 308-nm excimer light alone versus 308-nm excimer light and platelet-rich plasma in the treatment for localized vitiligo. J Cosmet Dermatol. 2022 Jul;21(7):2826-2831. doi: 10.1111/jocd.14582. Epub 2021 Oct 31.
PubMed 34719101Deng Y, Li J, Yang G. 308-nm Excimer Laser Plus Platelet-Rich Plasma for Treatment of Stable Vitiligo: A Prospective, Randomized Case-Control Study. Clin Cosmet Investig Dermatol. 2020 Jul 23;13:461-467. doi: 10.2147/CCID.S260434. eCollection 2020.
PubMed 32801821Ibrahim ZA, El-Ashmawy AA, El-Tatawy RA, Sallam FA. The effect of platelet-rich plasma on the outcome of short-term narrowband-ultraviolet B phototherapy in the treatment of vitiligo: a pilot study. J Cosmet Dermatol. 2016 Jun;15(2):108-16. doi: 10.1111/jocd.12194. Epub 2015 Dec 23.
PubMed 26695436
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma Intradermal Injection in Addition to 308 nm Excimer Light in the Treatment of Stable Acral Vitiligo: A Prospective Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06394349
- Acronym / sponsor ID
- 2023M-013
- Conditions
- Vitiligo
- Keywords
- Acral vitiligo, Platelet-rich plasma, 308 nm excimer light
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yijian ZhuUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 14 Oct 2024 (estimated)
- First posted
- 1 May 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.
The goal of this clinical trial is to learn if platelet-rich plasma (PRP) works to treat acral stable vitiligo in adults. It will also learn about the safety of platelet-rich plasma. The main questions it aims to answer are:
- Does PRP combined with 308 nm excimer phototherapy improve the efficacy compared to 308 nm excimer light alone in the treatment of vitiligo of the extremities?
- What medical problems do participants have when taking PRP intradermal injections?
Researchers will compare PRP to a placebo (a look-alike substance that contains no drug) to see if PRP works to treat acral vitiligo.
Participants will:
- Receive PRP intradermal injections once a month and 308 nm excimer phototherapy twice a week, or the same frequency of saline injections and phototherapy for 6 consecutive months
- Visit the clinic once every 1 month for evaluations
- Keep a diary of their symptoms or side effects during follow-up
Detailed description
Vitiligo is an acquired skin disorder characterized by depigmented macules, and one of the conventional treatment principles is to promote the differentiation of stem cells at the follicular bulge into melanocytes, but vitiligo of the extremities is clinically difficult to repigmentation and resistant to treatment due to its lack of hair follicles. Platelet-rich plasma (PRP) is a concentrated platelet plasma obtained by in vitro isolation of autologous whole blood, and its effect on repigmentation of vitiligo at the extremities and the potential mechanism remain unclear. The investigators investigated the efficacy of PRP on acral vitiligo by a single-center, prospective, self-controlled clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP+308nm | Experimental | Combination Product: PRP+308nmThe observation group received PRP intradermal injections (0.5cm apart, 0.02ml injected) once a month and 308 nm excimer phototherapy twice a week for 6 consecutive months. |
| NS+308nm | Placebo comparator | Combination Product: NS+308nmThe control group received the same frequency of saline injections (0.5cm apart, 0.02ml injected) and phototherapy for 6 consecutive months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-segmental vitiligo stable for more than half a year;
- At least 1 separate stable lesion on each of the dorsum of the right and left hands, proximal fingers, distal fingers and palms;
- The area of white spots is less than 10 % of the total body surface area and more than 1 % of the total body surface area;
- Those who have not received systemic treatment of vitiligo and phototherapy or related treatments within 1 month ≥ 1 year without significant efficacy;
- Voluntary signing of informed consent.
Key exclusion criteria (9 listed)
- Pregnant and lactating women;
- Those who have used glucocorticoids or other immunosuppressants in the last 3 months;
- Suffering from haematological disorders such as coagulation abnormalities and thrombocytopoietic disorders;
- Those who are allergic to ultraviolet light and photosensitive treatment;
- Scar constitution;
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 |
|---|---|---|
| PRP+308nmPRP+308nm | Combination product | PRP+308nm |
| NS+308nmNS+308nm | Combination product | NS+308nm |
Primary outcome
VASI (vitiligo area severity index) score
Time frame: up to 24 weeks
The calculation of VASI (vitiligo area severity index) scores was performed by analysing standard photographs taken in the clinic at each specified follow-up time. The range is 0-100 and lower scores mean a better outcome.
VASI improvement
Time frame: up to 24 weeks
VASI improvement rate = (VASI baseline - VASI follow-up) / VASI baseline × 100 %. The range is 0-100% and higher index means a better outcome.
Side effect questionnaire and Dermatology Life Quality Index (DLQI)
Time frame: up to 24 weeks
The side effect questionnaire includes discomfort such as pain, itching, erythema, or allergic reactions. The dermatology life quality index (DLQI) range is 0-30 and higher scores mean a better outcome.
3 secondary outcomes
Average pigmentation value, average erythema value
Time frame: up to 24 weeks
Pigment and erythema mode images
Time frame: up to 24 weeks
Repigmentation patterns
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Results publication: PubMed 34719101Elsaadany AE, El-Khalawany M, Elshahid AR, Seddeik Abdel-Hameed AK. Comparison between 308-nm excimer light alone versus 308-nm excimer light and platelet-rich plasma in the treatment for localized vitiligo. J Cosmet Dermatol. 2022 Jul;21(7):2826-2831. doi: 10.1111/jocd.14582. Epub 2021 Oct 31.
- Results publication: PubMed 32801821Deng Y, Li J, Yang G. 308-nm Excimer Laser Plus Platelet-Rich Plasma for Treatment of Stable Vitiligo: A Prospective, Randomized Case-Control Study. Clin Cosmet Investig Dermatol. 2020 Jul 23;13:461-467. doi: 10.2147/CCID.S260434. eCollection 2020.
- Results publication: PubMed 26695436Ibrahim ZA, El-Ashmawy AA, El-Tatawy RA, Sallam FA. The effect of platelet-rich plasma on the outcome of short-term narrowband-ultraviolet B phototherapy in the treatment of vitiligo: a pilot study. J Cosmet Dermatol. 2016 Jun;15(2):108-16. doi: 10.1111/jocd.12194. Epub 2015 Dec 23.
- Individual participant dataSharing planned: No
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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.
Yijian Zhu, M.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP+308nm and NS+308nm in people with Vitiligo, run by Yijian Zhu at 1 site in China.
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 5 inclusion and 9 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 1 May 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 China. 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. Some participants in this study may receive a placebo. 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 Yijian Zhu, M.D. (+8615921018163, jocelyn_zhu007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VASI (vitiligo area severity index) score (time frame: up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394349, which also lists 3 linked publications.
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 1 May 2024.