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

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ClinicalTrials.gov Identifier: NCT02506101
Recruitment Status : Terminated (Lack of enrollment and staff availability to administer treatment.)
First Posted : July 22, 2015
Results First Posted : December 11, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Vitiligo Pigmentation Dyschromia Device: narrow-band ultraviolet B phototherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo
Actual Study Start Date : July 2015
Actual Primary Completion Date : October 4, 2016
Actual Study Completion Date : October 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
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
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: no intervention
untreated



Primary Outcome Measures :
  1. Vitiligo Area Scoring Index (VASI) [ Time Frame: 24 weeks ]
    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 :
  1. Dermatology Life Quality Index (DLQI) [ Time Frame: 24 weeks ]
    Quality of life assessment

  2. Skindex-29 Questionnaire [ Time Frame: 24 weeks ]
    Quality of life assessment


Other Outcome Measures:
  1. Response Stability Index [ Time Frame: 24 weeks ]
  2. Number of Participants With Histological Change in Tissue Samples [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506101


Locations
United States, Maryland
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ginette Okoye, MD Johns Hopkins School of Medicine

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02506101     History of Changes
Other Study ID Numbers: IRB00052103
First Posted: July 22, 2015    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: April 3, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases