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TerminatedNCT02506101Updated Apr 3, 2018Results posted

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

An interventional study of narrow-band ultraviolet B phototherapy in Vitiligo, Pigmentation and Dyschromia, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-03.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of enrollment and staff availability to administer treatment.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Vitiligo
  • Pigmentation
  • Dyschromia

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03

In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

This study's enrollment of 2 is below the median of 30 across 227 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    narrow-band ultraviolet B phototherapy

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

    Device: narrow-band ultraviolet B phototherapy

  • No intervention
    no intervention

    untreated

Interventions

  • Devicenarrow-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.

06

What researchers measure

Primary outcomes

  1. 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 \[Hand Units\] ´ \[Residual depigmentation\].

    Time frame: 24 weeks

Secondary outcomes

  1. Dermatology Life Quality Index (DLQI)

    Quality of life assessment

    Time frame: 24 weeks

  2. Skindex-29 Questionnaire

    Quality of life assessment

    Time frame: 24 weeks

Other outcomes

  1. Response Stability Index

    Time frame: 24 weeks

  2. Number of Participants With Histological Change in Tissue Samples

    Time frame: 24 weeks

07

Results

Posted Dec 11, 2017
Limitations and caveats
The main limitation was the fact that study was a long term one and therefore participants could not keep pace with the visits and follow ups

Participant flow

Participant flow — Overall Study
MilestoneNarrow-band Ultraviolet B Phototherapyno Intervention
Started20
Completed00
Not completed20
Withdrew: Transportation issues10
Withdrew: No enrollment and staff unavailability10

Outcome measures

PrimaryVitiligo 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 \[Hand Units\] ´ \[Residual depigmentation\].

Time frame:
24 weeks

No measurements were reported for this outcome.

SecondaryDermatology Life Quality Index (DLQI)

Quality of life assessment

Time frame:
24 weeks

No measurements were reported for this outcome.

SecondarySkindex-29 Questionnaire

Quality of life assessment

Time frame:
24 weeks

No measurements were reported for this outcome.

Other pre-specifiedResponse Stability Index
Time frame:
24 weeks

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants With Histological Change in Tissue Samples
Time frame:
24 weeks

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Narrow-band Ultraviolet B Phototherapy0/2 (0%)0/2 (0%)1/2 (50%)
no Intervention———
Most frequent other events
Most frequent other events
EventNarrow-band Ultraviolet B Phototherapyno Intervention
Redness of the skin area in both axillae (armpit)Skin and subcutaneous tissue disorders1/2—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Narrow-band Ultraviolet B Phototherapyno InterventionTotal
<=18 years000
Between 18 and 65 years202
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Narrow-band Ultraviolet B Phototherapyno InterventionTotal
Female202
Male000
Region of Enrollment
Region of Enrollment(participants)Narrow-band Ultraviolet B Phototherapyno InterventionTotal
United States2—2
08

Study locations

1 site
  • Johns Hopkins Dept. of Dermatology
    Baltimore, Maryland 21287, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02506101
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Jul 22, 2015
Start date
Jul 2015
Primary completion
Oct 4, 2016
Completion
Oct 4, 2016
Results posted
Dec 11, 2017
Last update
Apr 3, 2018

Study contacts

Ginette Okoye, MD
principal investigator · Johns Hopkins School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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