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

NCT02506101 | Terminated Results

• 1 other identifier: IRB00052103
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Pigmentation; Dyschromia

Outcome Measures

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

  24 weeks

Secondary Outcomes (2)

• Dermatology Life Quality Index (DLQI)

  24 weeks

• Skindex-29 Questionnaire

  24 weeks

Other Outcomes (2)

• Response Stability Index

  24 weeks

• Number of Participants With Histological Change in Tissue Samples

  24 weeks

Study Arms (2)

narrow-band ultraviolet B phototherapy

EXPERIMENTAL

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

narrow-band ultraviolet B phototherapy 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.

narrow-band ultraviolet B phototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Dept. of Dermatology

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

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

Results Point of Contact

• Title: Dr. Ginette Okoye
• Organization: Johns Hopkins Medicine

CTReP@jhmi.edu

410-502-7546

Study Officials

• Ginette Okoye, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: October 4, 2016
• Study Completion: October 4, 2016
• Last Updated: April 3, 2018
• Results First Posted: December 11, 2017

Record last verified: 2018-03

Locations

US (1)