Trial Outcomes & Findings for BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort (NCT NCT04818138)
NCT ID: NCT04818138
Last Updated: 2026-07-21
Results Overview
The EASI measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 72. Higher scores indicate worse disease.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Week 12
Results posted on
2026-07-21
Participant Flow
Participant milestones
| Measure |
Narrowband UVB
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
Baseline characteristics by cohort
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 12.1 • n=9 Participants
|
37.1 years
STANDARD_DEVIATION 15.9 • n=27 Participants
|
35.1 years
STANDARD_DEVIATION 14.1 • n=267 Participants
|
|
Sex/Gender, Customized
Gender (female, male) · Female
|
19 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Gender (female, male) · Male
|
15 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=9 Participants
|
32 participants
n=27 Participants
|
66 participants
n=267 Participants
|
|
Eczema Area and Severity Index (EASI)
|
17.4 units on a scale
STANDARD_DEVIATION 8.8 • n=9 Participants
|
17 units on a scale
STANDARD_DEVIATION 9.7 • n=27 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 9.2 • n=267 Participants
|
|
Patient-Oriented Eczema Measure (POEM)
|
20.1 units on a scale
STANDARD_DEVIATION 5.9 • n=9 Participants
|
18.6 units on a scale
STANDARD_DEVIATION 6 • n=27 Participants
|
19.4 units on a scale
STANDARD_DEVIATION 5.9 • n=267 Participants
|
|
Peak Pruritus Numerical Rating Scale (PP-NRS)
|
7 units on a scale
STANDARD_DEVIATION 2.2 • n=9 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.3 • n=27 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 2.3 • n=267 Participants
|
|
Dermatology Life Quality Index (DLQI)
|
14.7 units on a scale
STANDARD_DEVIATION 7.1 • n=9 Participants
|
12.8 units on a scale
STANDARD_DEVIATION 6.4 • n=27 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 6.8 • n=267 Participants
|
|
Recap of Atopic Eczema (RECAP)
|
18.4 units on a scale
STANDARD_DEVIATION 6 • n=9 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 6.7 • n=27 Participants
|
17.4 units on a scale
STANDARD_DEVIATION 6.4 • n=267 Participants
|
|
Body Surface Area (BSA) involved with eczema
|
32.5 percentage of body surface area
STANDARD_DEVIATION 21.5 • n=9 Participants
|
32.7 percentage of body surface area
STANDARD_DEVIATION 22.5 • n=27 Participants
|
32.6 percentage of body surface area
STANDARD_DEVIATION 21.8 • n=267 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA- AD)
3 (Moderate)
|
22 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
|
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA- AD)
4 (Severe)
|
12 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Week 12The EASI measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 72. Higher scores indicate worse disease.
Outcome measures
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Absolute Change From Baseline (95% CrI) in the Eczema Area and Severity Index (EASI)
|
-8.9 units on a scale
Interval -13.0 to -4.9
|
-8.1 units on a scale
Interval -12.1 to -4.1
|
SECONDARY outcome
Timeframe: Week 12The Investigator Global Assessment (vIGA) measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 4. Higher scores indicate worse disease.
Outcome measures
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 12The POEM measures symptoms of atopic dermatitis. The minimum value is 0, the maximum is 28. Higher scores indicate more frequent symptoms.
Outcome measures
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Absolute Change From Baseline (95% CrI) in the Patient Oriented Eczema Measure (POEM)
|
-8 units on a scale
Interval -11.3 to -4.8
|
-8.3 units on a scale
Interval -11.8 to -4.9
|
SECONDARY outcome
Timeframe: Week 12The PP-NRS measures itch. The minimum value is 0, the maximum is 10. Higher scores indicate worse itch.
Outcome measures
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Absolute Change From Baseline (95% CrI) in the Peak Pruritus Numeric Rating Scale (PP-NRS)
|
-2.8 units on a scale
Interval -3.8 to -1.8
|
-2.3 units on a scale
Interval -3.3 to -1.2
|
SECONDARY outcome
Timeframe: Week 12The DLQI measures skin-specific quality of life. The minimum value is 0, the maximum is 30. Higher scores indicate worse impact on quality of life.
Outcome measures
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Absolute Change From Baseline (95% CrI) in the Dermatology Life Quality Index (DLQI)
|
-6.7 units on a scale
Interval -9.2 to -4.2
|
-6.4 units on a scale
Interval -9.2 to -3.7
|
SECONDARY outcome
Timeframe: Week 12The RECAP measures atopic dermatitis control. The minimum value is 0, the maximum is 28. Higher scores indicate worse atopic dermatitis control.
Outcome measures
| Measure |
Narrowband UVB
n=34 Participants
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 Participants
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Absolute Change From Baseline (95% CrI) in the Recap of Atopic Eczema (RECAP)
|
-8.5 units on a scale
Interval -11.2 to -5.9
|
-7.6 units on a scale
Interval -10.3 to -5.0
|
Adverse Events
Narrowband UVB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Broadband UVB
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Narrowband UVB
n=34 participants at risk
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Narrowband UVB phototherapy: Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
Broadband UVB
n=32 participants at risk
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapy: Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Number of participants who discontinued phototherapy treatment due to adverse event
|
0.00%
0/34 • From enrollment up to 12 +/- 2 weeks.
Local skin reactions and adverse events leading to treatment discontinuation (i.e., erythema, discomfort, pain, pruritus, Herpes simplex infection)
|
12.5%
4/32 • Number of events 4 • From enrollment up to 12 +/- 2 weeks.
Local skin reactions and adverse events leading to treatment discontinuation (i.e., erythema, discomfort, pain, pruritus, Herpes simplex infection)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place