Trial Outcomes & Findings for Blue Light Phototherapy (NCT NCT04343586)
NCT ID: NCT04343586
Last Updated: 2023-03-17
Results Overview
Demonstrate preliminary skin efficacy as measured by lesion count
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Time Frame: 5 weeks
Results posted on
2023-03-17
Participant Flow
Participant milestones
| Measure |
Adult Treatment Arm
Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.
Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blue Light Phototherapy
Baseline characteristics by cohort
| Measure |
Adult Treatment Arm
n=11 Participants
Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.
Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time Frame: 5 weeksDemonstrate preliminary skin efficacy as measured by lesion count
Outcome measures
| Measure |
Adult Treatment Arm
n=10 Participants
Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.
Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm
|
|---|---|
|
Efficacy of Blue Light Therapy for Patients With Grover's Disease
Baseline
|
27 lesion count
Interval 9.2 to 45.6
|
|
Efficacy of Blue Light Therapy for Patients With Grover's Disease
End of Treatment
|
6 lesion count
Interval 2.5 to 8.7
|
PRIMARY outcome
Timeframe: Time Frame: 5 weeksThe DLQI is a questionnaire with 10 questions. The maximum score is 30 and minimum is 0. The higher the score, the more quality of life is impaired.
Outcome measures
| Measure |
Adult Treatment Arm
n=10 Participants
Adults enrolled in the study will receive treatment (blue light phototherapy) on one area of their body affected by psoriasis or Grover's disease. The treatment area (restricted by size of the device) will be compared to untreated areas affected by disease on the same patient.
Blue light phototherapy: Phototherapy- Wavelength: 417±15 nm
|
|---|---|
|
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.
Baseline
|
4.3 score on a scale
Interval 1.3 to 7.4
|
|
Assess User Experience With the Dermatology Life Quality Index (DLQI) Pre and Post-treatment.
End of Treatment
|
2.3 score on a scale
Interval 1.3 to 3.4
|
Adverse Events
Adult Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place