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

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ClinicalTrials.gov Identifier: NCT02191748
Recruitment Status : Terminated (Principal investigator made the decision to close study and not submit a renewal. Lack of fixed research personnel to carry out the study effectively.)
First Posted : July 16, 2014
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE June 3, 2014
First Posted Date  ICMJE July 16, 2014
Last Update Posted Date July 25, 2017
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
Official Title  ICMJE Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE
  • Procedure: Needling
    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.
  • Drug: Triamcinolone
    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
    Other Name: Kenalog
Study Arms  ICMJE
  • Active Comparator: Needling
    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.
    Intervention: Procedure: Needling
  • Experimental: Needling and Triamcinolone
    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.
    Interventions:
    • Procedure: Needling
    • Drug: Triamcinolone
  • No Intervention: No treatment
    No treatment will be done to these vitiligo patches as a control.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 21, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2014)
60
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02191748
Other Study ID Numbers  ICMJE Pro2013003377
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Babar Rao, MD RWJUH Dermatology
PRS Account Rutgers, The State University of New Jersey
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP