search
Back to results

Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

Primary Purpose

Vitiligo

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost
Excimer laser
Microneedling with a dermaroller
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients 18 years and older with the diagnosis of Vitiligo.

Exclusion Criteria:

  • Female patients currently pregnant or lactating
  • Female patients with plans to come pregnant during the next 3 months
  • Allergic reactions to topical or oral prostaglandins
  • Uncontrolled skin disease
  • History of glaucoma
  • Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation.
  • Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation
  • Inability or unwillingness of subject or legal guardian/representative to give

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Area 1: Excimer laser, bimatoprost, and microneedling

Area 2: Excimer laser

Arm Description

Outcomes

Primary Outcome Measures

Percentage of skin repigmentation after 12 weeks
A blinded outcome accessor will compare photographs of patients before and after treatment.
Number of patients with perceived improvement after 12 weeks.
Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs.

Secondary Outcome Measures

Change in quality of life
To access vitiligo patient specifically though a QOL reliable and valid scale.
Change in quality of life
To access quality of life via a validated general Dermatology Life Quality Index Scale.

Full Information

First Posted
January 22, 2021
Last Updated
August 3, 2022
Sponsor
Medical University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT04738149
Brief Title
Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment
Official Title
A Proof of Concept, Split Study Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to treat vitiligo with a topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment. The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size. Enrolled subjects will present biweekly to clinic on the same two days for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions throughout the study. The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or then other available treatments for vitiligo, although this cannot be guaranteed.

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
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Area 1: Excimer laser, bimatoprost, and microneedling
Arm Type
Experimental
Arm Title
Area 2: Excimer laser
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bimatoprost
Intervention Description
Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
Excimer laser
Intervention Description
Participants will be receiving excimer laser 2x a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
Microneedling with a dermaroller
Intervention Description
Participants will have 4cm2 area pre-treated with dermaroller 2x per week for 12 weeks
Primary Outcome Measure Information:
Title
Percentage of skin repigmentation after 12 weeks
Description
A blinded outcome accessor will compare photographs of patients before and after treatment.
Time Frame
Post treatment (at week 12)
Title
Number of patients with perceived improvement after 12 weeks.
Description
Patients will be completing the Vitiligo Noticeability Scale that encompasses a series of questions assessing patient perceived change of before and after photographs.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
To access vitiligo patient specifically though a QOL reliable and valid scale.
Time Frame
Baseline and post treatment approximately 12 weeks
Title
Change in quality of life
Description
To access quality of life via a validated general Dermatology Life Quality Index Scale.
Time Frame
Baseline and post treatment approximately 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients 18 years and older with the diagnosis of Vitiligo. Exclusion Criteria: Female patients currently pregnant or lactating Female patients with plans to come pregnant during the next 3 months Allergic reactions to topical or oral prostaglandins Uncontrolled skin disease History of glaucoma Concomitant disease or therapy that interferes with the diagnosis that might interfere with vitiligo diagnosis sand evaluation. Patients currently using other treatments for Vitiligo, such as topical steroids, calcineurin inhibitors, and Vitamin D analogs within 2 weeks of study initiation Inability or unwillingness of subject or legal guardian/representative to give
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Microneedling, Bimatoprost and Excimer in Vitiligo Treatment

We'll reach out to this number within 24 hrs