VitiligoNCT05836441
Improved Phototherapy in Patients With Vitiligo
A study testing Exposure to white patches and Exposure to edge of white patches and normal skin around white patches in people with Vitiligo, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Vitiligo is a common acquired depigmentation skin and mucosal disease in dermatology, with or without white hair. Vitiligo with white hair is difficult to treat. Phototherapy and topical therapy are the first line treatment methods for vitiligo. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Exposure to white patches and Exposure to edge of white patches and normal skin around white patches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2023
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ① Age: 5 years old and above
- Gender: unlimited
- Types of vitiligo: sporadic vitiligo, facial and neck vitiligo, mixed vitiligo, undetermined vitiligo
- Vitiligo course: unlimited; ⑤ Vitiligo activity level: stable period; ⑥ At least one white spot meets the following four conditions simultaneously: Location: limited to the neck, trunk, and limbs (excluding hairless areas of hands and feet); There are no contraindications for the use of NB UVB phototherapy and topical tacrolimus; Area: 1cm2 < white spot area < 1% body surface area; The vellus hair in the white spot area is all white; ⑦ It is agreed to discontinue all forms of treatment that may change the study outcome during the study period, including western medicine, traditional Chinese medicine, traditional Chinese patent medicines and simple preparations, biological agents, etc., such as Dihydroketiazide, 8-M0P, osteotonic, angelica dahurica, etc; Willing and able to follow the visit and treatment plan.
Who cannot join
- ① Segmental vitiligo, generalized vitiligo, mucosal vitiligo, and acromegaly vitiligo;
- Degree of vitiligo activity: progression, rapid progression
- Kobner phenomenon or white spots located at the site of skin trauma, or other subjects requiring emergency intervention;
- Subjects who are sensitive to or have contraindications to ultraviolet radiation (suffering from photosensitive diseases such as xeroderma pigmentosum, porphyria, Bloom syndrome, systemic lupus erythematosus, dysplastic nevus syndrome, dermatomyositis, etc.);
- Subjects with a history of malignant tumors (including skin squamous cell carcinoma, melanoma or other skin and systemic malignant tumors);
- Subjects with severe systemic diseases;
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- Subjects who are allergic to tacrolimus ointment or excipients in the ointment; ⑧ Subjects who have received oral or systemic medication (such as corticosteroids, cyclosporine, methotrexate, tacrolimus, etc.) aimed at controlling/improving vitiligo symptoms within 4 weeks prior to baseline, or who require systemic use of corticosteroids or immunosuppressants for other reasons;
- ⑨ Subjects who have received any optical therapy (including sunbathing) for vitiligo within 4 weeks prior to baseline;
- ⑩ Subjects who have received topical treatment aimed at controlling/improving vitiligo symptoms (such as glucocorticoids, calcineurin inhibitors, vitamin D3 derivatives, etc.) within 2 weeks prior to baseline.
- ⑪ Pregnant and lactating female subjects;
- ⑫ Subjects who are judged by researchers to be unable to implement treatment plans correctly;
- ⑬ Child subjects who cannot cooperate with phototherapy protective measures;
Trial locations and contacts
1 site in 1 country.
Lu Yan, PhD contact
China1 site, 1 recruiting
- Recruiting
The first Affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, 210009
Lei Na, 18253707792, leina0829@163.com
About this study
Official title: A Multicenter, Randomized, Open, Parallel Controlled Clinical Study Evaluating the Efficacy and Safety of Improved Phototherapy in Patients With Vitiligo
Vitiligo is a common acquired depigmentation skin and mucosal disease in dermatology, with or without white hair. Vitiligo with white hair is difficult to treat. Phototherapy and topical therapy are the first line treatment methods for vitiligo. The peripheral leukoplakia irradiation of phototherapy covers the central area of the leukoplakia and performs phototherapy on the edge of the leukoplakia and surrounding normal skin. This study aims to compare the efficacy and safety of peripheral leukoplakia ultraviolet family phototherapy and leukoplakia family combination in the treatment of vitiligo.
- Conditions
- Vitiligo
- Being tested
- Exposure to white patches, Exposure to edge of white patches and normal skin around white patches
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to white patchesRadiation
Also called Tacrolimus
Exposure to white patches
Exposure to edge of white patches and normal skin around white patchesRadiation
Exposure to edge of white patches and normal skin around white patches
| Study group | Role | What they receive |
|---|---|---|
| White spot irradiation group | Active comparator | Exposure to white patches Receives: Radiation: Exposure to white patches |
| White spot edge irradiation group | Experimental | Exposure to edge of white patches and normal skin around white patches Receives: Radiation: Exposure to edge of white patches and normal skin around white patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage reduction in vitiligo area
mean percentage reduction in vitiligo area from baseline to week 12
Measured: week12 after intervention
Secondary outcomes (2)
percentage reduction of leukotrichia in vitiligo region
average percentage reduction of leukotrichia in vitiligo region from baseline to week 12
Measured: week12 after intervention
NB-UVB dose
Using the following Equation 1 : φ=E*T (E refers to irradiation intensity [mW/cm2] ; φ refers to irradiation dose [mJ/cm2]; T refers to irradiation time [sec]) to calculate the effective NB-UVB dose for patients at week 12
Measured: week12 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jan 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Dec 2023 (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.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu Yan, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836441
- Sponsor's protocol ID
- NJmedical
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open, Parallel Controlled Clinical Study Evaluating the Efficacy and Safety of Improved Phototherapy in Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT05836441
- Acronym / sponsor ID
- NJmedical
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 May 2023 (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 common acquired depigmentation skin and mucosal disease in dermatology, with or without white hair. Vitiligo with white hair is difficult to treat. Phototherapy and topical therapy are the first line treatment methods for vitiligo. The peripheral leukoplakia irradiation of phototherapy covers the central area of the leukoplakia and performs phototherapy on the edge of the leukoplakia and surrounding normal skin. This study aims to compare the efficacy and safety of peripheral leukoplakia ultraviolet family phototherapy and leukoplakia family combination in the treatment of vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| White spot irradiation group | Active comparator | Radiation: Exposure to white patchesExposure to white patches |
| White spot edge irradiation group | Experimental | Radiation: Exposure to edge of white patches and normal skin around white patchesExposure to edge of white patches and normal skin around white patches |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ① Age: 5 years old and above
Key exclusion criteria (12 listed)
- ① Segmental vitiligo, generalized vitiligo, mucosal vitiligo, and acromegaly vitiligo;
- ⑨ Subjects who have received any optical therapy (including sunbathing) for vitiligo within 4 weeks prior to baseline;
- ⑩ Subjects who have received topical treatment aimed at controlling/improving vitiligo symptoms (such as glucocorticoids, calcineurin inhibitors, vitamin D3 derivatives, etc.) within 2 weeks prior to baseline.
- ⑪ Pregnant and lactating female subjects;
- ⑫ Subjects who are judged by researchers to be unable to implement treatment plans correctly;
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 |
|---|---|---|
| Exposure to white patchesAlso: TacrolimusExposure to white patches | Radiation | White spot irradiation group |
| Exposure to edge of white patches and normal skin around white patchesExposure to edge of white patches and normal skin around white patches | Radiation | White spot edge irradiation group |
Primary outcome
percentage reduction in vitiligo area
Time frame: week12 after intervention
mean percentage reduction in vitiligo area from baseline to week 12
2 secondary outcomes
percentage reduction of leukotrichia in vitiligo region
Time frame: week12 after intervention
NB-UVB dose
Time frame: week12 after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- 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.
Lu Yan, PhD contact
Lu Yan study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to white patches and Exposure to edge of white patches and normal skin around white patches in people with Vitiligo, run by The First Affiliated Hospital with Nanjing Medical University 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 4 inclusion and 12 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 2023. 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. 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 lu Yan, PhD (13913967126, luyan6289@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage reduction in vitiligo area (time frame: week12 after intervention). 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 1 May 2023.