Trial Outcomes & Findings for Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D. (NCT NCT02735187)
NCT ID: NCT02735187
Last Updated: 2019-01-08
Results Overview
The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
week 12
Results posted on
2019-01-08
Participant Flow
A total number of 51 patients were enrolled for the study at 1 study site in Germany between March and April 2016. 140 patients were pre-screened.
Participant milestones
| Measure |
group30
Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15
Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Blue Light (453 nm) Treatment for Mild Psoriasis Vulgaris Over Three Months Compared to Vitamin D.
Baseline characteristics by cohort
| Measure |
group30
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15
n=26 Participants
Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
45.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Skin type
Type I
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Skin type
Type II
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Skin type
Type III
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Skin type
Type IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Skin type
Type V
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Skin type
Type VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 12Population: Full Analysis Set (FAS)
The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=25 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 30) as Compared to the VitaminD Treated Area (Control) at End of Treatment (Week 12).
|
-2.4 units on a scale
Standard Deviation 1.45
|
-2.4 units on a scale
Standard Deviation 1.38
|
—
|
—
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis Set
The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4 each). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.
Outcome measures
| Measure |
group30 (Blue Light)
n=26 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 15) as Compared to the VitaminD Treated (Control) Area at End of Treatment (Week 12).
|
-2.4 units on a scale
Standard Deviation 1.65
|
-2.5 units on a scale
Standard Deviation 1.56
|
—
|
—
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis set
Patient Rating of severity of Psoriasis Plaques on a 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 cm corresponds to no pain,, VAS = 10 cm corresponds to maximal imaginable pain.
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=25 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 30) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
|
-3.82 units on a scale
Standard Deviation 2.70
|
-3.56 units on a scale
Standard Deviation 2.73
|
—
|
—
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis set
Patient Rating of severity of Psoriasis Plaques on 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 corresponds to no symptoms of Psoriasis, VAS = 10 corresponds to most severe symptoms of Psoriasis.
Outcome measures
| Measure |
group30 (Blue Light)
n=26 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 15) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).
|
-2.92 units on a scale
Standard Deviation 2.44
|
-2.44 units on a scale
Standard Deviation 2.79
|
—
|
—
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis set
Lesional erythema was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the redness of the skin (range 0-99). 0 = no redness and 99 = maximal redness.
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=25 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
n=26 Participants
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Lesional Erythema Measured by Mexameter Measured at End of Treatment.
|
65.44 units on a scale
Standard Deviation 16.29
|
65.32 units on a scale
Standard Deviation 14.27
|
59.88 units on a scale
Standard Deviation 10.94
|
61.50 units on a scale
Standard Deviation 11.75
|
SECONDARY outcome
Timeframe: week 12Population: Full Analysis set
Patient satisfaction will be measured by questionnaire using the System usability score (SUS). The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. The higher the score the better the patient satisfaction the better the outcome. The lower the score the worse the patient satisfaction the worse the outcome.
Outcome measures
| Measure |
group30 (Blue Light)
n=21 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=20 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Patient Satisfaction (Week 12)
|
88.62 units on a scale
Standard Deviation 7.92
|
89.00 units on a scale
Standard Deviation 8.71
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 2-16Population: Safety Set
Lesional tanning was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the brownish color of the skin (range 0-99). 0 = no tanning and 99 = maximal tanning.
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=25 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
n=26 Participants
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter
week 2
|
26.72 units on a scale
Standard Deviation 7.20
|
24.16 units on a scale
Standard Deviation 3.77
|
24.65 units on a scale
Standard Deviation 6.72
|
22.92 units on a scale
Standard Deviation 3.78
|
|
Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter
week 4
|
25.48 units on a scale
Standard Deviation 5.95
|
24.52 units on a scale
Standard Deviation 5.93
|
24.15 units on a scale
Standard Deviation 3.90
|
23.12 units on a scale
Standard Deviation 3.60
|
|
Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter
week 8
|
27.40 units on a scale
Standard Deviation 6.89
|
25.00 units on a scale
Standard Deviation 4.21
|
25.31 units on a scale
Standard Deviation 8.99
|
22.35 units on a scale
Standard Deviation 6.24
|
|
Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter
week 16
|
25.76 units on a scale
Standard Deviation 4.61
|
25.16 units on a scale
Standard Deviation 4.67
|
26.31 units on a scale
Standard Deviation 7.04
|
25.04 units on a scale
Standard Deviation 7.13
|
|
Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter
week 12/End of treatment
|
25.60 units on a scale
Standard Deviation 5.11
|
24.96 units on a scale
Standard Deviation 4.23
|
26.15 units on a scale
Standard Deviation 5.90
|
24.15 units on a scale
Standard Deviation 5.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0-16Population: Safety set
Adverse Events (serious and non-serious) collected during the study conduct.
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Adverse Events (Serious and Non-serious)
Any adverse events
|
4 Number of adverse events
|
10 Number of adverse events
|
—
|
—
|
|
Adverse Events (Serious and Non-serious)
Causal related to IMD
|
0 Number of adverse events
|
0 Number of adverse events
|
—
|
—
|
|
Adverse Events (Serious and Non-serious)
Causal related to medical procedure
|
1 Number of adverse events
|
0 Number of adverse events
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0-16Population: Safety set
Adverse device effects collected during the study conduct.
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Adverse Device Effects
|
0 Number of adverse device effects
|
0 Number of adverse device effects
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 0-12Population: Safety set
The number of device deficiencies was collected throughout the study
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Device Deficiencies
|
2 Number of device deficiencies
|
2 Number of device deficiencies
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 12Population: Safety set
Thermal comfort will be measured by questionaire: How comfortable was this temperature on your skin?
Outcome measures
| Measure |
group30 (Blue Light)
n=25 Participants
Treatment of the target area with 30 minutes of blue light at 453nm
|
group30 (Comparator)
n=26 Participants
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15 (Blue Light)
Treatment of the target area with 15 minutes of blue light at 453nm
|
group15 (Comparator)
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|---|---|
|
Thermal Comfort
Slightly comfortable
|
2 Count of Participants
|
3 Count of Participants
|
—
|
—
|
|
Thermal Comfort
Comfortable
|
7 Count of Participants
|
10 Count of Participants
|
—
|
—
|
|
Thermal Comfort
Very comfortable
|
0 Count of Participants
|
0 Count of Participants
|
—
|
—
|
|
Thermal Comfort
Very uncomfortable
|
0 Count of Participants
|
0 Count of Participants
|
—
|
—
|
|
Thermal Comfort
Uncomfortable
|
0 Count of Participants
|
0 Count of Participants
|
—
|
—
|
|
Thermal Comfort
Slightly uncomfortable
|
5 Count of Participants
|
4 Count of Participants
|
—
|
—
|
|
Thermal Comfort
Just right
|
9 Count of Participants
|
8 Count of Participants
|
—
|
—
|
|
Thermal Comfort
No data
|
2 Count of Participants
|
1 Count of Participants
|
—
|
—
|
Adverse Events
group30
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
group15
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
group30
n=25 participants at risk
Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15
n=26 participants at risk
Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
Other adverse events
| Measure |
group30
n=25 participants at risk
Treatment of the target area with 30 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
group15
n=26 participants at risk
Treatment of the target area with 15 minutes of blue light at 453nm compared to VitaminD creme Daivonex on contralateral Plaque of same patient.
Blue light treatment: Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
Vitamin D: Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
|
|---|---|---|
|
Infections and infestations
Tonsillitis
|
4.0%
1/25 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
0.00%
0/26 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Infections and infestations
Viral infection
|
4.0%
1/25 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
0.00%
0/26 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Nervous system disorders
Migraine
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/25 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.0%
1/25 • Number of events 1 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
0.00%
0/26 • Adverse events were collected during the complete 16 weeks of the clinical Investigation.
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in patients, users or other persons whether or not related to the investigational medical device. This includes events related to the investigational device or the comparator. This includes events related to the procedures involved. For users or other persons this is restricted to events related to the investigational medical device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place