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Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo

Primary Purpose

Vitiligo

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Needling
Triamcinolone
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Patients with 3 or more localized patches of stable vitiligo
  • 2. No prior treatment or had failed previous vitiligo treatments

Exclusion Criteria:

  • 1. Unstable vitiligo
  • 2. Allergic to triamcinolone
  • 3. Systemic treatments
  • 4. Pregnancy

Sites / Locations

  • RWJUH Dermatology office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Needling

Needling and Triamcinolone

No treatment

Arm Description

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.

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.

No treatment will be done to these vitiligo patches as a control.

Outcomes

Primary Outcome Measures

Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy
Repigmentation of vitiligo patch using confocal microscopy

Secondary Outcome Measures

Photography measure to assess repigmentation
Wood's lamp to assess repigmentation
Photography measure to assess repigmentation
Photography measure to assess repigmentation
Photography measure to assess repigmentation
Photography measure to assess repigmentation
Photography measure to assess repigmentation
Photography measure to assess repigmentation
Photography measure to assess repigmentation
Wood's lamp to assess repigmentation
Wood's lamp to assess repigmentation
Wood's lamp to assess repigmentation
Wood's lamp to assess repigmentation
Wood's lamp to assess repigmentation
Wood's lamp to assess repigmentation
Wood's lamp to assess repigmentation

Full Information

First Posted
June 3, 2014
Last Updated
July 21, 2017
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02191748
Brief Title
Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
Official Title
Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Needling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Needling and Triamcinolone
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment will be done to these vitiligo patches as a control.
Intervention Type
Procedure
Intervention Name(s)
Needling
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Kenalog
Intervention Description
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
Primary Outcome Measure Information:
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
baseline
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 4 post treatment (only if repigmentation become first apparent at this time point)
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 8 post treatment (only if repigmentation become first apparent at this time point
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 12 post treatment (only if repigmentation become first apparent at this time point
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 16 post treatment (only if repigmentation become first apparent at this time point
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 20 post treatment (only if repigmentation become first apparent at this time point
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 24 post treatment (only if repigmentation become first apparent at this time point
Title
Repigmentation of vitiligo patch using confocal microscopy
Time Frame
week 28 post treatment
Secondary Outcome Measure Information:
Title
Photography measure to assess repigmentation
Time Frame
baseline
Title
Wood's lamp to assess repigmentation
Time Frame
baseline
Title
Photography measure to assess repigmentation
Time Frame
week 4 post treatment
Title
Photography measure to assess repigmentation
Time Frame
week 8 post treatment
Title
Photography measure to assess repigmentation
Time Frame
week 12 post treatment
Title
Photography measure to assess repigmentation
Time Frame
week 16 post treatment
Title
Photography measure to assess repigmentation
Time Frame
week 20 post treatment
Title
Photography measure to assess repigmentation
Time Frame
week 24 post treatment
Title
Photography measure to assess repigmentation
Time Frame
week 28 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 4 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 8 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 12 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 16 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 20 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 24 post treatment
Title
Wood's lamp to assess repigmentation
Time Frame
week 28 post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients with 3 or more localized patches of stable vitiligo 2. No prior treatment or had failed previous vitiligo treatments Exclusion Criteria: 1. Unstable vitiligo 2. Allergic to triamcinolone 3. Systemic treatments 4. Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babar Rao, MD
Organizational Affiliation
RWJUH Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
RWJUH Dermatology office
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States

12. IPD Sharing Statement

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Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo

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