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Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Primary Purpose

Vitiligo, Dermatology/Skin - Other

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Dermatology, Johns Hopkins, Compensation, Paid, Phototherapy, NB-UVB, Light treatment, Skin, Biopsies, Money, Short-term

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adults 18 years or older with bilateral symmetrical vitiligo lesions, in general good health as determined by the Principal Investigator by medical history and physical exam.
Able to understand consent procedure
Able to comply with protocol activities

Exclusion Criteria:

Patients less than 18 years old
Patients not able to understand consent procedure
Patients unable to comply with protocol activities
Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English.
Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity
Patients receiving concomitant phototherapy to test sites
Patient receiving topical medication to test sites within 2 weeks of study initiation
Patient receiving oral medications for vitiligo within 4 weeks prior to study initiation
Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study initiation
Pregnant or nursing patients (self-reported)
Patient with significant medical history or concurrent illness that the investigator feels is not safe for study participation, including melanoma
Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.
Patients with history of excessive scar or keloid formation in the past 10 years
Patients with known allergy to anesthetic used
Subjects with a pacemaker, implanted cardioverter-defibrillator, baroreflex activation device, cochlear implant, implanted bone growth stimulator, robotic limb prosthesis, subcutaneous GPS tracking device, electrodes implanted in the brain, attached electrodes in a subject undergoing cardiac defibrillation during the moment of skin color reading, or other device which may be disrupted by electrical current, UNLESS subject is kept "1 yard (one arm's length) from the main unit" of the spectrophotometer at all times, as specified in device approval letter.

Sites / Locations

Johns Hopkins Outpatient Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phototherapy (NB-UVB)

Arm Description

Phototherapy (NB-UVB) will be administered for all enrolled subjects. The starting dosage will be 250 mJ/cm2. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment.

Outcomes

Primary Outcome Measures

Molecular changes from NB-UVB therapy

The investigators are assessing the histological and molecular changes of normal and Vitiligo-lesion skin from NB-UVB therapy. The molecular markers (in microgram/ mL) include, but not limited to, KIT receptor, stem cell factor (SCF), tumor necrosis factor-alpha (TNF-alpha), and interleukin-1 (IL-1).

Secondary Outcome Measures

Full Information

NCT ID

NCT03270241

First Posted

August 28, 2017

Last Updated

July 13, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03270241

Brief Title

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Official Title

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

March 14, 2023 (Actual)

Study Completion Date

March 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has been shown to promote repigmentation and normalize cellular behaviors. The investigators would like to analyze the change in protein expression and histological change in skin from NB-UVB treatment in participants with Vitiligo. The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.

Detailed Description

This is a dermatology study of the effects of short-term NB-UVB treatment, standard phototherapy for Vitiligo patients. In the study, demographics information, three ascending dose of phototherapy, and small skin biopsies will be required of the participants. For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2, which is the standard of care for patients with Vitiligo. The dose will be increased by 10% with each treatment, as long as there are no side effects with treatment such as burning or redness/ erythema. Small skin biopsies will be collected from normal skin and from affected skin from vitiligo participants at the baseline visit and 3 days after the conclusion of treatment; up to a total of 6 biopsies will be collected from each patient. Participants will be compensated for time and effort.

6. Conditions and Keywords

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

Vitiligo, Dermatology/Skin - Other

Keywords

Vitiligo, Dermatology, Johns Hopkins, Compensation, Paid, Phototherapy, NB-UVB, Light treatment, Skin, Biopsies, Money, Short-term

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Participants diagnosed with Vitiligo who are enrolled in the study will receive phototherapy (NB-UVB), with the starting dose of 250 mJ/cm2. The dose will be increased by 10% with each treatment. Small skin samples will be collected before and after NB-UVB treatment.

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phototherapy (NB-UVB)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet

Intervention Description

This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.

Primary Outcome Measure Information:

Title

Molecular changes from NB-UVB therapy

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults 18 years or older with bilateral symmetrical vitiligo lesions, in general good health as determined by the Principal Investigator by medical history and physical exam. Able to understand consent procedure Able to comply with protocol activities Exclusion Criteria: Patients less than 18 years old Patients not able to understand consent procedure Patients unable to comply with protocol activities Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English. Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity Patients receiving concomitant phototherapy to test sites Patient receiving topical medication to test sites within 2 weeks of study initiation Patient receiving oral medications for vitiligo within 4 weeks prior to study initiation Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study initiation Pregnant or nursing patients (self-reported) Patient with significant medical history or concurrent illness that the investigator feels is not safe for study participation, including melanoma Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy. Patients with history of excessive scar or keloid formation in the past 10 years Patients with known allergy to anesthetic used Subjects with a pacemaker, implanted cardioverter-defibrillator, baroreflex activation device, cochlear implant, implanted bone growth stimulator, robotic limb prosthesis, subcutaneous GPS tracking device, electrodes implanted in the brain, attached electrodes in a subject undergoing cardiac defibrillation during the moment of skin color reading, or other device which may be disrupted by electrical current, UNLESS subject is kept "1 yard (one arm's length) from the main unit" of the spectrophotometer at all times, as specified in device approval letter.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noori Kim, M.D

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Outpatient Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The investigators are still deciding on what information to release to other researchers.

Learn more about this trial

Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy

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