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

NCT ID: NCT02506101

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-10-04

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:

1. 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.

2. 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.

Conditions

Vitiligo; Pigmentation; Dyschromia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

narrow-band ultraviolet B phototherapy

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

Group Type: EXPERIMENTAL

narrow-band ultraviolet B phototherapy

Intervention Type: DEVICE

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.

no intervention

untreated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

narrow-band ultraviolet B phototherapy

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.

Intervention Type: DEVICE

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ginette Okoye, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins Dept. of Dermatology

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00052103

Identifier Type: -

Identifier Source: org_study_id