VitiligoNCT02506101
Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo
A study testing narrow-band ultraviolet B phototherapy in people with Vitiligo and Pigmentation, run by Johns Hopkins University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Pigmentation, Dyschromia
- What is being tested?
- narrow-band ultraviolet B phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 4 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, 21287
About this study
Official title: Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo
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:
- 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.
- Conditions
- Vitiligo, Pigmentation, Dyschromia
- Being tested
- narrow-band ultraviolet B phototherapy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narrow-band ultraviolet B phototherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| narrow-band ultraviolet B phototherapy | Experimental | We will use the 3 Series PC \& SP Phototherapy Cabinet for treatment of vitiligo. Receives: Device: narrow-band ultraviolet B phototherapy |
| no intervention | No intervention | untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 24 weeks
Secondary outcomes (2)
Dermatology Life Quality Index (DLQI)
Quality of life assessment
Measured: 24 weeks
Skindex-29 Questionnaire
Quality of life assessment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion4 Oct 2016
- Study completion4 Oct 2016
Why it stopped: Lack of enrollment and staff availability to administer treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ginette Okoye, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506101
- Sponsor's protocol ID
- IRB00052103
- Status last verified
- Mar 2018
- First submitted
- 21 Jul 2015
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo
- ClinicalTrials.gov ID
- NCT02506101
- Acronym / sponsor ID
- IRB00052103
- Conditions
- Vitiligo, Pigmentation, Dyschromia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment and staff availability to administer treatment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 11 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| narrow-band ultraviolet B phototherapy | Experimental | Device: narrow-band ultraviolet B phototherapyWe will use the 3 Series PC \& SP Phototherapy Cabinet for treatment of vitiligo. |
| no intervention | No intervention | –untreated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| narrow-band ultraviolet B phototherapyThere 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. | Device | narrow-band ultraviolet B phototherapy |
Primary outcome
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].
2 secondary outcomes
Dermatology Life Quality Index (DLQI)
Time frame: 24 weeks
Skindex-29 Questionnaire
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ginette Okoye, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing narrow-band ultraviolet B phototherapy in people with Vitiligo and Pigmentation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitiligo Area Scoring Index (VASI) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.