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Trial record 100 of 272 for:    Betamethasone

Adherence in Topical Treatment of Psoriasis

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ClinicalTrials.gov Identifier: NCT02858713
Recruitment Status : Completed
First Posted : August 8, 2016
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Mathias Tiedemann Svendsen, Odense University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Adherence
Interventions Drug: Calcipotriene + Betamethasone Dipropionate
Device: App
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title App as Intervention + Enstilar© Conventional Instructions + Enstilar©
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 68 66
Completed 61 61
Not Completed 7 5
Arm/Group Title App as Intervention + Enstilar© Conventional Instructions + Enstilar© Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 68 66 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 66 participants 134 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
  77.9%
53
  80.3%
106
  79.1%
>=65 years
15
  22.1%
13
  19.7%
28
  20.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants 66 participants 134 participants
50
(23 to 75)
48
(21 to 72)
48
(21 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 66 participants 134 participants
Female
27
  39.7%
25
  37.9%
52
  38.8%
Male
41
  60.3%
41
  62.1%
82
  61.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Denmark Number Analyzed 68 participants 66 participants 134 participants
68
 100.0%
66
 100.0%
134
 100.0%
1.Primary Outcome
Title Percentage of Adherent Participants
Hide Description 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
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title App as Intervention + Enstilar© Conventional Instructions + Enstilar©
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 68 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65
(53 to 77)
38
(26 to 51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection App as Intervention + Enstilar©, Conventional Instructions + Enstilar©
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.99
Confidence Interval (2-Sided) 95%
1.42 to 6.28
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Dermatology Life Quality Index (DLQI)
Hide Description

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.

Time Frame Baseline, week 4, 8 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Patients lost to follow-up
Arm/Group Title Conventional Instructions + Enstilar© App as Intervention + Enstilar©
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Conventional Instructions + Enstilar© Changing from baseline to week 4
App as intervention + Enstilar© Changing from baseline to week 4
Overall Number of Participants Analyzed 66 68
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to week 4 Number Analyzed 66 participants 68 participants
4.54
(3.47 to 5.61)
4.12
(3.27 to 4.98)
Change from baseline to week 8 Number Analyzed 63 participants 64 participants
5.17
(3.92 to 6.43)
4.59
(3.71 to 5.48)
Change from baseline to week 26 Number Analyzed 61 participants 61 participants
5.00
(3.69 to 6.31)
4.23
(3.25 to 5.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App as Intervention + Enstilar©
Comments DLQI: Change baseline to week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.545
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value -0.415
Confidence Interval (2-Sided) 95%
-1.770 to 0.939
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App as Intervention + Enstilar©
Comments DLQI: Change from baseline to week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.545
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value -0.415
Confidence Interval (2-Sided) 95%
-1.770 to 0.939
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App as Intervention + Enstilar©
Comments DLQI: Change from baseline to week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value -0.581
Confidence Interval (2-Sided) 95%
-2.099 to 0.938
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App as Intervention + Enstilar©
Comments DLQI: Change from baseline to week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value -0.770
Confidence Interval (2-Sided) 95%
-2.389 to 0.848
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Lattice-System Physician's Global Assessment (LS-PGA)
Hide Description

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.

Time Frame Week 4, 8 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Lost to follow-up
Arm/Group Title Conventional Instructions + Enstilar© App + Enstilar©
Hide Arm/Group Description:
Conventional Instructions + Enstilar© arm changing in LS-PGA form baseline to week 26.
App + Enstilar© arm changing in LS-PGA from baseline to week 26
Overall Number of Participants Analyzed 66 68
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from baseline to week 4 Number Analyzed 65 participants 65 participants
1.46
(1.17 to 1.75)
1.86
(1.59 to 2.13)
Change from baseline to week 8 Number Analyzed 63 participants 64 participants
2.16
(1.86 to 2.46)
2.25
(1.96 to 2.54)
Change from baseline to week 26 Number Analyzed 61 participants 61 participants
1.80
(1.49 to 2.11)
1.98
(1.66 to 2.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App + Enstilar©
Comments LS-PGA: Change from baseline to week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter coefficient
Estimated Value 0.400
Confidence Interval (2-Sided) 95%
0.005 to 0.795
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App + Enstilar©
Comments LS-PGA: Change from baseline to week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value 0.091
Confidence Interval (2-Sided) 95%
-0.321 to 0.504
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional Instructions + Enstilar©, App + Enstilar©
Comments LS-PGA: Change from baseline to week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Coefficient
Estimated Value 0.180
Confidence Interval (2-Sided) 95%
-0.264 to 0.625
Estimation Comments [Not Specified]
Time Frame Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Instructions + App as Intervention + Enstilar© App as Intervention + Enstilar©
Hide Arm/Group Description

Information obtained baseline, week 4, 8 and 26.

Participants were treated with Enstilar© once daily when needed for 6 months

Information obtained baseline, week 4, 8 and 26.

Participants were treated with Enstilar© once daily when needed for 6 months

All-Cause Mortality
Conventional Instructions + App as Intervention + Enstilar© App as Intervention + Enstilar©
Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)      0/68 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Instructions + App as Intervention + Enstilar© App as Intervention + Enstilar©
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      1/68 (1.47%)    
Musculoskeletal and connective tissue disorders     
Infection in knee prosthesis  [1]  0/66 (0.00%)  0 1/68 (1.47%)  1
Indicates events were collected by systematic assessment
[1]
Infection in knee prosthesis. Not Associated with the use of Cal/BD foam.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Instructions + App as Intervention + Enstilar© App as Intervention + Enstilar©
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/66 (33.33%)      20/68 (29.41%)    
Ear and labyrinth disorders     
Nausea   2/66 (3.03%)  2 1/68 (1.47%)  1
Hepatobiliary disorders     
Elevated liver enzymes  [1]  2/66 (3.03%)  2 1/68 (1.47%)  1
Infections and infestations     
Lung and skin infections  [2]  4/66 (6.06%)  4 4/68 (5.88%)  4
Musculoskeletal and connective tissue disorders     
various musculoskelatal disorders  [2]  4/66 (6.06%)  4 4/68 (5.88%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
relapse of carcinoma in situ of the glottis  [3]  0/66 (0.00%)  0 1/68 (1.47%)  1
Renal and urinary disorders     
Elevated creatinin levels   0/66 (0.00%)  0 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
Worsening of chronic obstructive pumonary disease (COPD)  [4]  1/66 (1.52%)  1 0/68 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin manifestations  [5]  8/66 (12.12%)  8 8/68 (11.76%)  8
Vascular disorders     
Fainting  [6]  1/66 (1.52%)  1 0/68 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Elevated liver enzymes after treatment with methotrexate. Not related to use of Cal/BD foam
[2]
Not related to the use of Cal/BD foam
[3]
Not related to use of Cal/BD foam
[4]
Associated to accidentally inhaling gas from canister containing Cal/BD foam
[5]
11 different skin manifestations not directly related to use of Enstilar
[6]
Fainting not related to use of Cal/BD foam
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M.D. Mathias Tiedemann Svendsen
Organization: Department of Dermatology, Odense University Hospital
Phone: +45 61265827
EMail: m_tiedemann@hotmail.dk
Layout table for additonal information
Responsible Party: Mathias Tiedemann Svendsen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02858713     History of Changes
Other Study ID Numbers: 2016-002143-42
First Submitted: August 3, 2016
First Posted: August 8, 2016
Results First Submitted: December 11, 2017
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019