Trial Outcomes & Findings for Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo (NCT NCT02506101)
NCT ID: NCT02506101
Last Updated: 2018-04-03
Results Overview
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 \[Hand Units\] ´ \[Residual depigmentation\].
TERMINATED
NA
2 participants
24 weeks
2018-04-03
Participant Flow
Participant milestones
| Measure |
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.
|
no Intervention
untreated
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
no Intervention
untreated
|
|---|---|---|
|
Overall Study
Transportation issues
|
1
|
0
|
|
Overall Study
No enrollment and staff unavailability
|
1
|
0
|
Baseline Characteristics
Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo
Baseline characteristics by cohort
| Measure |
Narrow-band Ultraviolet B Phototherapy
n=2 Participants
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.
|
no Intervention
untreated
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
—
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.
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 \[Hand Units\] ´ \[Residual depigmentation\].
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.
Quality of life assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.
Quality of life assessment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.
Outcome measures
Outcome data not reported
Adverse Events
Narrow-band Ultraviolet B Phototherapy
no Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Narrow-band Ultraviolet B Phototherapy
n=2 participants at risk
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.
|
no Intervention
untreated
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness of the skin area in both axillae (armpit)
|
50.0%
1/2 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place