Clinical trial NCT02506101: 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
Overall status: TERMINATED
Phase: NA
Conditions: Vitiligo
Pigmentation
Dyschromia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 24 weeks
measure: Skindex-29 Questionnaire
timeFrame: 24 weeks
Other outcomes:
measure: Response Stability Index
timeFrame: 24 weeks
measure: Number of Participants With Histological Change in Tissue Samples
timeFrame: 24 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Dept. of Dermatology
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Ginette Okoye, MD
role: PRINCIPAL_INVESTIGATOR
References: