Trial Outcomes & Findings for Improvement of Psoriasis Patients' Adherence to Topical Drugs (NCT NCT04220554)
NCT ID: NCT04220554
Last Updated: 2024-01-30
Results Overview
Lattice-System Physician's Global Assessment (LS-PGA) (interval scale). From value 1 (no visible psoriasis) to 8 (severely affected by psoriasis).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
Change from baseline at week 48
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Intervention Group
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
45
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improvement of Psoriasis Patients' Adherence to Topical Drugs
Baseline characteristics by cohort
| Measure |
Intervention Group
n=51 Participants
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
n=52 Participants
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Continuous
|
58 years
n=99 Participants
|
52.5 years
n=107 Participants
|
55.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
51 participants
n=99 Participants
|
52 participants
n=107 Participants
|
103 participants
n=206 Participants
|
|
Severity of psoriasis: Lattice System Physician's Global Assessment (LS-PGA)
|
5.3 units on a scale
n=99 Participants
|
5.1 units on a scale
n=107 Participants
|
5.2 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at week 48Lattice-System Physician's Global Assessment (LS-PGA) (interval scale). From value 1 (no visible psoriasis) to 8 (severely affected by psoriasis).
Outcome measures
| Measure |
Intervention Group
n=45 Participants
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
n=47 Participants
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
|---|---|---|
|
Severity of Psoriasis
|
2.68 units on a scale
Interval 2.2 to 3.15
|
1.84 units on a scale
Interval 1.46 to 2.22
|
SECONDARY outcome
Timeframe: Week 48Population: The number participants analyzed is not consistent with the participant flow chart, since some patients did not return the medication packages and therefore their data could not be included in the analysis of secondary adherence.
Proportion of expected consumed amount of topical drugs. Secondary adherence was calculated by combining measured amount of medication used (determined by the weight of the remains in the used medication packages) per body surface area unit affected. Estimated recommended consumption of medication was 0.5 g per day multiplied by the estimated mean body surface area (BSA) during the whole study period, calculated from BSA measures at baseline and at weeks 12, 24, 36, and 48.
Outcome measures
| Measure |
Intervention Group
n=44 Participants
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
n=44 Participants
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
|---|---|---|
|
Secondary Adherence
|
106 percentage of adherence
Interval 68.0 to 144.0
|
72 percentage of adherence
Interval 49.0 to 95.0
|
SECONDARY outcome
Timeframe: Change from baseline to week 48Dermatology Life Quality Index (DLQI) (interval scale). From value 0 (no impact on quality of life) to 30 (severe impact on quality of life).
Outcome measures
| Measure |
Intervention Group
n=45 Participants
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
n=47 Participants
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
|---|---|---|
|
Quality of Life (QOL)
|
6.88 units on a scale
Interval 5.83 to 7.93
|
1.55 units on a scale
Interval 0.51 to 2.6
|
Adverse Events
Intervention Group
Serious events: 20 serious events
Other events: 22 other events
Deaths: 0 deaths
Non-intervention Group
Serious events: 12 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention Group
n=51 participants at risk
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
n=52 participants at risk
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
3.8%
2/52 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Number of events 6 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Reproductive system and breast disorders
Inflammation of epididymis
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Gastrointestinal disorders
Abscess in anogenital area
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Endocrine disorders
Primary adrenal insufficiency
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Endocrine disorders
Dysregulated diabetes mellitus
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Psychiatric disorders
Alcohol withdrawal
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Psychiatric disorders
Mania
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Ear and labyrinth disorders
Ear stone dizziness
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular adenoma
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Nervous system disorders
Commotio cerebri
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Renal and urinary disorders
Exacerbation of chronic renal failure
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Respiratory, thoracic and mediastinal disorders
Acute sore throat
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Psychiatric disorders
Depression
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell skin cancer
|
5.9%
3/51 • Number of events 3 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Endocrine disorders
Osteoporosis
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthritis
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
Other adverse events
| Measure |
Intervention Group
n=51 participants at risk
Intervention group:
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
During the study period, a nurse or pharmaconomist will deliver;
* Improved support and instructions to the patients
* Patients will receive a diary and access to more consultations.
Improved support by health-care professionals: Improved support to patients prescribed topical antipsoriatic drugs
|
Non-intervention Group
n=52 participants at risk
All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bacterial folliculitis
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Deep bacterial inflammation in the subcutaneous tissue
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Erysipelas
|
3.9%
2/51 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
9.6%
5/52 • Number of events 5 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Boil
|
3.9%
2/51 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Dermatophytosis
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
5.8%
3/52 • Number of events 3 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
5.8%
3/52 • Number of events 3 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Urticaria acuta
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
3.9%
2/51 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Hidrosadenitis suppurativa
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Spontaneous ecchymoses
|
19.6%
10/51 • Number of events 10 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Skin and subcutaneous tissue disorders
Dysesthesia of the skin
|
2.0%
1/51 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
0.00%
0/52 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Vascular disorders
Superficial vein trombosis
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
1.9%
1/52 • Number of events 1 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
|
Musculoskeletal and connective tissue disorders
Fractura caput radii
|
0.00%
0/51 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
3.8%
2/52 • Number of events 2 • 48 weeks.
Adverse event recording was collected by systematic interview and patient charts.
|
Additional Information
Consultant, MD, PhD Mathias Tiedemann Svendsen
University of Southern Denmark
Phone: 0045 61265827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place