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Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo

Primary Purpose

Vitiligo, Pigmentation, Dyschromia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

narrow-band ultraviolet B phototherapy

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
If a woman, before entry she must be:
1. postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or >45 years of age with amenorrhea for at least 6 months and a serum follicule stimulating hormone (FSH) level >40 IU/mL, or surgically postmenopausal (bilateral oophorectomy), or
2. surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or
3. If heterosexually active and of childbearing potential, practicing a highly effective method of birth control, (examples include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragms, or cervical cap, with spermicidal foam, cream, or gel), or male partner sterilization consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study, or
4. Not heterosexually active

Exclusion Criteria:

Patients less than 18 years old
Patients not able to understand consent procedure
Patients unable to comply with protocol activities
Patients that do not have bilateral symmetrical vitiligo lesions
Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English. Given the lack of translators in over 50% of patient encounters in the dermatology clinic and the interpreters' limited time commitments when one does show up, it is impossible to safely enroll or follow patients who do not speak English. Phone translators are impossible given that we have written consent forms, which often exceed 10 pages in length.
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
Systemic corticosteroid therapy within the past month Concurrent use of drugs listed in Appendix C.

Sites / Locations

Johns Hopkins Dept. of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

narrow-band ultraviolet B phototherapy

no intervention

Arm Description

We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.

untreated

Outcomes

Primary Outcome Measures

Vitiligo Area Scoring Index (VASI)

VASI scores of treated versus untreated symmetrical body sites.The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites [Hand Units] ´ [Residual depigmentation].

Secondary Outcome Measures

Dermatology Life Quality Index (DLQI)

Quality of life assessment

Skindex-29 Questionnaire

Quality of life assessment

Full Information

NCT ID

NCT02506101

First Posted

July 21, 2015

Last Updated

March 9, 2018

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT02506101

Brief Title

Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo

Official Title

Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment and staff availability to administer treatment.

Study Start Date

July 2015 (Actual)

Primary Completion Date

October 4, 2016 (Actual)

Study Completion Date

October 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to assess the effectiveness and safety of narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.

Detailed Description

Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy is a clinically indicated treatment for skin lesions. Treatments are usually administered in an outpatient setting, typically three times per week. This is a proof-of-concept study as there are few well-designed prospective clinical studies showing the efficacy of NB-UVB phototherapy in the treatment of vitiligo in terms of repigmentation and quality of life. The following are the proposed objectives of this study: NB-UVB phototherapy improves vitiligo with at least 50% repigmentation compared to no treatment on affected areas of the trunk and extremities over 24 weeks. NB-UVB phototherapy leads to improvement in quality of life as measured by standardized quality of life metrics (DLQI and Skindex-29) over 24 weeks.

6. Conditions and Keywords

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

Vitiligo, Pigmentation, Dyschromia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

narrow-band ultraviolet B phototherapy

Arm Type

Experimental

Arm Description

We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.

Arm Title

no intervention

Arm Type

No Intervention

Arm Description

untreated

Intervention Type

Device

Intervention Name(s)

narrow-band ultraviolet B phototherapy

Intervention Description

There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week.

Primary Outcome Measure Information:

Title

Vitiligo Area Scoring Index (VASI)

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Dermatology Life Quality Index (DLQI)

Description

Quality of life assessment

Time Frame

24 weeks

Title

Skindex-29 Questionnaire

Description

Quality of life assessment

Time Frame

24 weeks

Other Pre-specified Outcome Measures:

Title

Response Stability Index

Time Frame

24 weeks

Title

Number of Participants With Histological Change in Tissue Samples

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 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 If a woman, before entry she must be: postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or >45 years of age with amenorrhea for at least 6 months and a serum follicule stimulating hormone (FSH) level >40 IU/mL, or surgically postmenopausal (bilateral oophorectomy), or surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or If heterosexually active and of childbearing potential, practicing a highly effective method of birth control, (examples include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragms, or cervical cap, with spermicidal foam, cream, or gel), or male partner sterilization consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study, or Not heterosexually active Exclusion Criteria: Patients less than 18 years old Patients not able to understand consent procedure Patients unable to comply with protocol activities Patients that do not have bilateral symmetrical vitiligo lesions Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English. Given the lack of translators in over 50% of patient encounters in the dermatology clinic and the interpreters' limited time commitments when one does show up, it is impossible to safely enroll or follow patients who do not speak English. Phone translators are impossible given that we have written consent forms, which often exceed 10 pages in length. 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 Systemic corticosteroid therapy within the past month Concurrent use of drugs listed in Appendix C.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ginette Okoye, MD

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Dept. of Dermatology

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo

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