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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506101

Enrollment

Registered

2015-07-22

Start date

2015-07-31

Completion date

2016-10-04

Last updated

2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyschromia, Pigmentation, Vitiligo

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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Vitiligo Area Scoring Index (VASI)	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

Measure	Time frame	Description
Dermatology Life Quality Index (DLQI)	24 weeks	Quality of life assessment
Skindex-29 Questionnaire	24 weeks	Quality of life assessment

Other

Measure	Time frame
Response Stability Index	24 weeks
Number of Participants With Histological Change in Tissue Samples	24 weeks

Countries

United States

Participant flow

Participants by arm

Arm	Count
Narrow-band Ultraviolet B Phototherapy We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo. 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.	2
no Intervention untreated	0
Total	2

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	No enrollment and staff unavailability	1	0
Overall Study	Transportation issues	1	0

Baseline characteristics

Characteristic	Narrow-band Ultraviolet B Phototherapy	no Intervention	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	2 Participants	0 Participants	2 Participants
Region of Enrollment United States	2 participants	—	2 participants
Sex: Female, Male Female	2 Participants	0 Participants	2 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 2	0 / 0
other Total, other adverse events	1 / 2	0 / 0
serious Total, serious adverse events	0 / 2	0 / 0

Outcome results

Primary

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