- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506101
Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo
Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Dept. of Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: narrow-band ultraviolet B phototherapy
We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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].
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dermatology Life Quality Index (DLQI)
Time Frame: 24 weeks
|
Quality of life assessment
|
24 weeks
|
Skindex-29 Questionnaire
Time Frame: 24 weeks
|
Quality of life assessment
|
24 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response Stability Index
Time Frame: 24 weeks
|
24 weeks
|
Number of Participants With Histological Change in Tissue Samples
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ginette Okoye, MD, Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00052103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitiligo
-
PfizerRecruitingStable Nonsegmental Vitiligo | Active Nonsegmental VitiligoUnited States, Spain, Australia, Mexico, Canada, China, Japan, Italy, Turkey, Korea, Republic of, Germany, South Africa, Poland, United Kingdom, Bulgaria
-
PfizerRecruitingStable Nonsegmental Vitiligo | Active Nonsegmental VitiligoJapan, Canada, China, United States
-
Fundació Institut de Recerca de l'Hospital de la...Completed
-
Incyte CorporationRecruitingNonSegmental VitiligoGermany, United States, Italy, Poland, Canada, France, Bulgaria, Hungary, United Kingdom
-
Incyte CorporationCompletedNonSegmental VitiligoUnited States, Canada
-
Cairo UniversitySuspended
-
Assiut UniversityUnknown
-
University of TorontoCanadian Interdisciplinary Network Complementary & Alternative Medicine ResearchCompleted
-
University Hospital, GhentNovartisCompletedVitiligo VulgarisBelgium
Clinical Trials on narrow-band ultraviolet B phototherapy
-
Cytokind, Inc.Baylor College of Medicine; Louisiana State University Health Sciences Center... and other collaboratorsCompletedAutoimmune Diseases | Covid19 | Corona Virus Infection | Coagulation Disorder, BloodUnited States
-
South Valley UniversityCompleted
-
National Institute of Allergy and Infectious Diseases...PPD; Amgen; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)Recruiting
-
Incyte CorporationCompletedVitiligoUnited States, Canada
-
Cairo UniversityCompletedActive Non Segmental VitiligoEgypt
-
Assiut UniversityUnknown
-
University of PennsylvaniaPatient-Centered Outcomes Research Institute; University of Utah; National Psoriasis...Completed
-
Brigham and Women's HospitalDana-Farber Cancer InstituteTerminatedOral Chronic Graft-Versus-Host DiseaseUnited States
-
Derm Research, PLLCGenentech, Inc.; Dermatology Associates, PLLCCompletedPlaque PsoriasisUnited States
-
National Taiwan University HospitalCompletedUremic PruritusTaiwan