VitiligoPhase 2/3NCT02191748
Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
A Phase 2/3 study testing Needling and Triamcinolone in people with Vitiligo, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Needling and Triamcinolone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2018
- Phase
- Phase 2/3
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with 3 or more localized patches of stable vitiligo
- 2. No prior treatment or had failed previous vitiligo treatments
Who cannot join
- 1. Unstable vitiligo
- 2. Allergic to triamcinolone
- 3. Systemic treatments
- 4. Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
RWJUH Dermatology office
Somerset, New Jersey, 08873
About this study
Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment. There is a need for new, effective modalities to treat patients with otherwise refractory vitiligo.
Needling is an office based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results.
The proposed randomized control trial (RCT) will further investigate the use of needling to treat vitiligo. It differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using confocal microscopy. Confocal microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has been used in the past to diagnose cutaneous pigmentary conditions. This study would be the first RCT of needling in vitiligo to use an objective measure to quantify results, thus has the potential to establish needling as a novel, effective treatment for vitiligo and to evaluate the utility of CFM for monitoring response to treatment.
- Conditions
- Vitiligo
- Being tested
- Needling, Triamcinolone
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeedlingProcedure or surgery
Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch.
TriamcinoloneDrug
Also called Kenalog
During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area
| Study group | Role | What they receive |
|---|---|---|
| Needling | Active comparator | Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. Saline, which doesn't affect repigmentation in vitiligo, will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of saline injected at each site. Receives: Procedure: Needling |
| Needling and Triamcinolone | Experimental | During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site. Receives: Procedure: Needling; Drug: Triamcinolone |
| No treatment | No intervention | No treatment will be done to these vitiligo patches as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation of vitiligo patch using confocal microscopy
Measured: baseline
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 4 post treatment (only if repigmentation become first apparent at this time point)
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 8 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 12 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 16 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 20 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 24 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Measured: week 28 post treatment
Secondary outcomes (16)
Photography measure to assess repigmentation
Measured: baseline
Wood's lamp to assess repigmentation
Measured: baseline
Photography measure to assess repigmentation
Measured: week 4 post treatment
Photography measure to assess repigmentation
Measured: week 8 post treatment
Photography measure to assess repigmentation
Measured: week 12 post treatment
Photography measure to assess repigmentation
Measured: week 16 post treatment
Photography measure to assess repigmentation
Measured: week 20 post treatment
Photography measure to assess repigmentation
Measured: week 24 post treatment
Photography measure to assess repigmentation
Measured: week 28 post treatment
Wood's lamp to assess repigmentation
Measured: week 4 post treatment
Wood's lamp to assess repigmentation
Measured: week 8 post treatment
Wood's lamp to assess repigmentation
Measured: week 12 post treatment
Wood's lamp to assess repigmentation
Measured: week 16 post treatment
Wood's lamp to assess repigmentation
Measured: week 20 post treatment
Wood's lamp to assess repigmentation
Measured: week 24 post treatment
Wood's lamp to assess repigmentation
Measured: week 28 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Principal investigator made the decision to close study and not submit a renewal. Lack of fixed research personnel to carry out the study effectively.
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 Rutgers, The State University of New JerseyThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Babar Rao, MD, Principal investigator, RWJUH Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191748
- Sponsor's protocol ID
- Pro2013003377
- Status last verified
- Jul 2017
- First submitted
- 3 Jun 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
- ClinicalTrials.gov ID
- NCT02191748
- Acronym / sponsor ID
- Pro2013003377
- Conditions
- Vitiligo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator made the decision to close study and not submit a renewal. Lack of fixed research personnel to carry out the study effectively.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Jul 2014 (estimated)
- 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 an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment. There is a need for new, effective modalities to treat patients with otherwise refractory vitiligo.
Needling is an office based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results.
The proposed randomized control trial (RCT) will further investigate the use of needling to treat vitiligo. It differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using confocal microscopy. Confocal microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has been used in the past to diagnose cutaneous pigmentary conditions. This study would be the first RCT of needling in vitiligo to use an objective measure to quantify results, thus has the potential to establish needling as a novel, effective treatment for vitiligo and to evaluate the utility of CFM for monitoring response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Needling | Active comparator | Procedure: NeedlingNeedling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. Saline, which doesn't affect repigmentation in vitiligo, will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of saline injected at each site. |
| Needling and Triamcinolone | Experimental | Procedure: Needling, Drug: TriamcinoloneDuring the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site. |
| No treatment | No intervention | –No treatment will be done to these vitiligo patches as a control. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients with 3 or more localized patches of stable vitiligo
- 2. No prior treatment or had failed previous vitiligo treatments
Key exclusion criteria (4 listed)
- 1. Unstable vitiligo
- 2. Allergic to triamcinolone
- 3. Systemic treatments
- 4. Pregnancy
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 |
|---|---|---|
| NeedlingNeedling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. | Procedure or surgery | Needling, Needling and Triamcinolone |
| TriamcinoloneAlso: KenalogDuring the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area | Drug | Needling and Triamcinolone |
Primary outcome
Repigmentation of vitiligo patch using confocal microscopy
Time frame: baseline
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 4 post treatment (only if repigmentation become first apparent at this time point)
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 8 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 12 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 16 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 20 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 24 post treatment (only if repigmentation become first apparent at this time point
Repigmentation of vitiligo patch using confocal microscopy
Time frame: week 28 post treatment
16 secondary outcomes
Photography measure to assess repigmentation
Time frame: baseline
Wood's lamp to assess repigmentation
Time frame: baseline
Photography measure to assess repigmentation
Time frame: week 4 post treatment
Photography measure to assess repigmentation
Time frame: week 8 post treatment
Photography measure to assess repigmentation
Time frame: week 12 post treatment
Photography measure to assess repigmentation
Time frame: week 16 post treatment
Photography measure to assess repigmentation
Time frame: week 20 post treatment
Photography measure to assess repigmentation
Time frame: week 24 post treatment
Photography measure to assess repigmentation
Time frame: week 28 post treatment
Wood's lamp to assess repigmentation
Time frame: week 4 post treatment
Wood's lamp to assess repigmentation
Time frame: week 8 post treatment
Wood's lamp to assess repigmentation
Time frame: week 12 post treatment
Wood's lamp to assess repigmentation
Time frame: week 16 post treatment
Wood's lamp to assess repigmentation
Time frame: week 20 post treatment
Wood's lamp to assess repigmentation
Time frame: week 24 post treatment
Wood's lamp to assess repigmentation
Time frame: week 28 post treatment
Results and safety
The study was stopped early (reason given: Principal investigator made the decision to close study and not submit a renewal. Lack of fixed research personnel to carry out the study effectively.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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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.
Babar Rao, MD principal investigator
RWJUH Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Needling and Triamcinolone in people with Vitiligo, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 25 Jul 2017. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Principal investigator made the decision to close study and not submit a renewal. Lack of fixed research personnel to carry out the study effectively.). 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?
Repigmentation of vitiligo patch using confocal microscopy (time frame: baseline). The study lists 8 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 25 Jul 2017.