A Study to Evaluate the Efficacy of Microneedling as a Stand-alone Treatment for Vitiligo

NCT05053022 | Completed FDA Device

• 1 other identifier: CL-VL-21-04
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic susceptibility.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment (PGA)

  PGA to be completed starting at Visit 2 and on, prior to each treatment. The primary endpoint is to achieve Grade 2, 3 or 4 on the PGA Scale comparing photographs from baseline to visits 12, 13, and 14. This is a 5 Grade Repigmentation Scale. This assessment uses a scale of G0-G4. This global assessment will be done by the investigator starting at Visit 2 and afterwards. G4 Excellent \> 75% Repigmentation G3 Very Good 50%-75% Repigmentation G2 Good 25%-50% Repigmentation G1 Satisfactory \<25% Repigmentation G0 Poor No Repigmentation

  Through Study Completion, over the course of 244 days

Secondary Outcomes (1)

• Subject's assessment of their pre and post-treatment images using the Vitiligo Noticeability Scale (VNS)

  Through Study Completion, over the course of 244 days

Study Arms (1)

Microneedling with Skinpen Precision System

EXPERIMENTAL

Skinpen precision system will be used in accordance with the instructions in the IFU on the treatment area. A numbing cream will be applied at least 20-30 minutes before the Skinpen Precision system treatment is done. The affected areas will be treated at depths of up to 2.50mm. Treatment depth will be recorded for each treatment at every visit. Subjects will be dispensed with the Blue Lizard sunscreen and trained on proper use.

Device: Skinpen Precision System

Interventions

Skinpen Precision System DEVICE

Subjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions.

Microneedling with Skinpen Precision System

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male or female, ages 18 through 60.
• Clinical diagnosis of stable Vitiligo (no changes within the past 6 months) on any of the following body areas: face, neck, trunk, extremities, hands, feet (excluding digits).
• Subjects in generally good health and free of any conditions which, in the opinion of the investigator, would interfere with the study assessments.
• Subjects willing to discontinue all current therapies for vitiligo for the duration of the study.
• Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit and Final visit.
• Individuals that are willing to provide written informed consent and are able to read, speak, write and understand the informed consent document.
• Willingness to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.

You may not qualify if:

• Individuals diagnosed with known allergies to facial or general skin care products.
• Individuals who have presence of an active systemic or local skin disease, apart from vitiligo, that may affect wound healing. Uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
• Individuals with sensitivity to topical lidocaine, stainless steel, nickel, or chromium
• Individuals who have a recent or current history of inflammatory skin disease or cancerous/pre-cancerous lesion.
• Subjects currently or within the past 3 months on Vitiligo topical or systemic treatments.
• Use of skin lighteners or bleaching agents; hydroquinone, phenol peels or harsh chemicals.
• Individuals who have the inability to understand instructions or to give informed consent.
• Individuals who have a history of chronic drug or alcohol abuse.
• Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Individuals who are current smokers.
• Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
• Individuals with a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.
• Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study.
• Individuals who have any condition, which in the opinion of the Investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments)

Sponsors & Collaborators

• Crown Laboratories, Inc.: lead

Study Sites (1)

Crown Laboratories

Dallas, Texas, 75234, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A proof of concept study to determine the safety and efficacy of Microneedling in patients with stable Vitiligo.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 22, 2021
• Study Start: July 29, 2021
• Primary Completion: November 21, 2022
• Study Completion: January 24, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)