Trial Outcomes & Findings for Adherence in Topical Treatment of Psoriasis (NCT NCT02858713)
NCT ID: NCT02858713
Last Updated: 2019-06-03
Results Overview
Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
134 participants
Primary outcome timeframe
Week 4
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
App as Intervention + Enstilar©
Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Enstilar 0.005%-0.064% Topical Foam
|
Conventional Instructions + Enstilar©
Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Enstilar 0.005%-0.064% Topical Foam
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
66
|
|
Overall Study
COMPLETED
|
61
|
61
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
App as Intervention + Enstilar©
n=68 Participants
Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Enstilar 0.005%-0.064% Topical Foam
|
Conventional Instructions + Enstilar©
n=66 Participants
Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Enstilar 0.005%-0.064% Topical Foam
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=134 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=68 Participants
|
53 Participants
n=66 Participants
|
106 Participants
n=134 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=68 Participants
|
13 Participants
n=66 Participants
|
28 Participants
n=134 Participants
|
|
Age, Continuous
|
50 years
n=68 Participants
|
48 years
n=66 Participants
|
48 years
n=134 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=68 Participants
|
25 Participants
n=66 Participants
|
52 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=68 Participants
|
41 Participants
n=66 Participants
|
82 Participants
n=134 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
68 Participants
n=68 Participants
|
66 Participants
n=66 Participants
|
134 Participants
n=134 Participants
|
PRIMARY outcome
Timeframe: Week 4Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent
Outcome measures
| Measure |
App as Intervention + Enstilar©
n=68 Participants
Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Enstilar 0.005%-0.064% Topical Foam
|
Conventional Instructions + Enstilar©
n=66 Participants
Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Enstilar 0.005%-0.064% Topical Foam
|
|---|---|---|
|
Percentage of Adherent Participants
|
65 percentage of participants
Interval 53.0 to 77.0
|
38 percentage of participants
Interval 26.0 to 51.0
|
SECONDARY outcome
Timeframe: Baseline, week 4, 8 and 26Population: Patients lost to follow-up
Change from baseline to week 4 Description of Dermatology Life Quality Index (DLQI): A score from 0-30 \[0, patients' quality of life not affected; 30, patients' quality of life severely affected by the skin disease\]. The DLQI-scale is a summary of 10 questions on subscales, where patients' report how severely their quality of life has been affected for the last week (patient reported outcome measurements (PROM), each subscale have a score from 0 (not affected by skin disease) to 3 (severely affected by skin disease). The minimum score is 0 and the highest score is 30, a high score means worse outcome.
Outcome measures
| Measure |
App as Intervention + Enstilar©
n=66 Participants
Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Enstilar 0.005%-0.064% Topical Foam
|
Conventional Instructions + Enstilar©
n=68 Participants
Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Enstilar 0.005%-0.064% Topical Foam
|
|---|---|---|
|
Dermatology Life Quality Index (DLQI)
Change from baseline to week 4
|
4.54 units on a scale
Interval 3.47 to 5.61
|
4.12 units on a scale
Interval 3.27 to 4.98
|
|
Dermatology Life Quality Index (DLQI)
Change from baseline to week 8
|
5.17 units on a scale
Interval 3.92 to 6.43
|
4.59 units on a scale
Interval 3.71 to 5.48
|
|
Dermatology Life Quality Index (DLQI)
Change from baseline to week 26
|
5.00 units on a scale
Interval 3.69 to 6.31
|
4.23 units on a scale
Interval 3.25 to 5.21
|
SECONDARY outcome
Timeframe: Week 4, 8 and 26Population: Lost to follow-up
Change from baseline to week 4, 8 and 26 Lattice System Physican's Gloabal Assessment (LS-PGA) is a measure from 0-8 (0, patients skin clear; 8, patients' skin severely affected by psoriasis). The scale is a summary of three subscales: 1). thickness of psoriasis, 2). extent of scaling and 3). body surface ares (BSA) affected. The minimum score is 0 and the maximum score is 8, a high score represents a worse outcome.
Outcome measures
| Measure |
App as Intervention + Enstilar©
n=66 Participants
Patients prescribed Enstilar© receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Enstilar 0.005%-0.064% Topical Foam
|
Conventional Instructions + Enstilar©
n=68 Participants
Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Enstilar 0.005%-0.064% Topical Foam
|
|---|---|---|
|
Lattice-System Physician's Global Assessment (LS-PGA)
Change from baseline to week 4
|
1.46 units on a scale
Interval 1.17 to 1.75
|
1.86 units on a scale
Interval 1.59 to 2.13
|
|
Lattice-System Physician's Global Assessment (LS-PGA)
Change from baseline to week 8
|
2.16 units on a scale
Interval 1.86 to 2.46
|
2.25 units on a scale
Interval 1.96 to 2.54
|
|
Lattice-System Physician's Global Assessment (LS-PGA)
Change from baseline to week 26
|
1.80 units on a scale
Interval 1.49 to 2.11
|
1.98 units on a scale
Interval 1.66 to 2.31
|
Adverse Events
Conventional Instructions + App as Intervention + Enstilar©
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
App as Intervention + Enstilar©
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conventional Instructions + App as Intervention + Enstilar©
n=66 participants at risk
Information obtained baseline, week 4, 8 and 26.
Participants were treated with Enstilar© once daily when needed for 6 months
|
App as Intervention + Enstilar©
n=68 participants at risk
Information obtained baseline, week 4, 8 and 26.
Participants were treated with Enstilar© once daily when needed for 6 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Infection in knee prosthesis
|
0.00%
0/66 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
1.5%
1/68 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
Other adverse events
| Measure |
Conventional Instructions + App as Intervention + Enstilar©
n=66 participants at risk
Information obtained baseline, week 4, 8 and 26.
Participants were treated with Enstilar© once daily when needed for 6 months
|
App as Intervention + Enstilar©
n=68 participants at risk
Information obtained baseline, week 4, 8 and 26.
Participants were treated with Enstilar© once daily when needed for 6 months
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
relapse of carcinoma in situ of the glottis
|
0.00%
0/66 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
1.5%
1/68 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of chronic obstructive pumonary disease (COPD)
|
1.5%
1/66 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
0.00%
0/68 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Ear and labyrinth disorders
Nausea
|
3.0%
2/66 • Number of events 2 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
1.5%
1/68 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
3.0%
2/66 • Number of events 2 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
1.5%
1/68 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Renal and urinary disorders
Elevated creatinin levels
|
0.00%
0/66 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
1.5%
1/68 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Skin and subcutaneous tissue disorders
Skin manifestations
|
12.1%
8/66 • Number of events 8 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
11.8%
8/68 • Number of events 8 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Musculoskeletal and connective tissue disorders
various musculoskelatal disorders
|
6.1%
4/66 • Number of events 4 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
5.9%
4/68 • Number of events 4 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Vascular disorders
Fainting
|
1.5%
1/66 • Number of events 1 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
0.00%
0/68 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
|
Infections and infestations
Lung and skin infections
|
6.1%
4/66 • Number of events 4 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
5.9%
4/68 • Number of events 4 • Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
|
Additional Information
M.D. Mathias Tiedemann Svendsen
Department of Dermatology, Odense University Hospital
Phone: +45 61265827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place