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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

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.


Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Needling Drug: Triamcinolone Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo
Study Start Date : September 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
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.
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.

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.
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

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



Primary Outcome Measures :
  1. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: baseline ]
  2. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 4 post treatment (only if repigmentation become first apparent at this time point) ]
  3. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 8 post treatment (only if repigmentation become first apparent at this time point ]
  4. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 12 post treatment (only if repigmentation become first apparent at this time point ]
  5. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 16 post treatment (only if repigmentation become first apparent at this time point ]
  6. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 20 post treatment (only if repigmentation become first apparent at this time point ]
  7. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 24 post treatment (only if repigmentation become first apparent at this time point ]
  8. Repigmentation of vitiligo patch using confocal microscopy [ Time Frame: week 28 post treatment ]

Secondary Outcome Measures :
  1. Photography measure to assess repigmentation [ Time Frame: baseline ]
  2. Wood's lamp to assess repigmentation [ Time Frame: baseline ]
  3. Photography measure to assess repigmentation [ Time Frame: week 4 post treatment ]
  4. Photography measure to assess repigmentation [ Time Frame: week 8 post treatment ]
  5. Photography measure to assess repigmentation [ Time Frame: week 12 post treatment ]
  6. Photography measure to assess repigmentation [ Time Frame: week 16 post treatment ]
  7. Photography measure to assess repigmentation [ Time Frame: week 20 post treatment ]
  8. Photography measure to assess repigmentation [ Time Frame: week 24 post treatment ]
  9. Photography measure to assess repigmentation [ Time Frame: week 28 post treatment ]
  10. Wood's lamp to assess repigmentation [ Time Frame: week 4 post treatment ]
  11. Wood's lamp to assess repigmentation [ Time Frame: week 8 post treatment ]
  12. Wood's lamp to assess repigmentation [ Time Frame: week 12 post treatment ]
  13. Wood's lamp to assess repigmentation [ Time Frame: week 16 post treatment ]
  14. Wood's lamp to assess repigmentation [ Time Frame: week 20 post treatment ]
  15. Wood's lamp to assess repigmentation [ Time Frame: week 24 post treatment ]
  16. Wood's lamp to assess repigmentation [ Time Frame: week 28 post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191748


Locations
United States, New Jersey
RWJUH Dermatology office
Somerset, New Jersey, United States, 08873
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Babar Rao, MD RWJUH Dermatology

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02191748     History of Changes
Other Study ID Numbers: Pro2013003377
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action