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There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to monitor the effect of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcipotriol plus hydrocortisone (LEO 80190) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol plus hydrocortisone (LEO 80190) | Drug | Once daily application |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low. | At Week 4 (Day 28) and Week 8 (Day 56) |
| Change in Albumin Corrected Serum Calcium | Baseline was defined as the last assessment performed before study medication application. The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). | From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Measure | Description | Time Frame |
|---|---|---|
| The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainard Fuhr, MD, PhD | Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceuticals | Hot Springs | Arkansas | 71913 | United States | ||
| Dermatology Research of Arkansas |
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The treatment phase was divided into two 4-week treatment periods during which the overall treatment duration had to be 28 days or 56 days. The participant was to leave the study if they were clear according to the investigator's global assessment of disease severity (IGA) of the face and of the intertriginous areas at Visit 3 (Day 28).
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcipotriol Plus Hydrocortisone (LEO 80190) | Calcipotriol plus hydrocortisone (LEO 80190) ointment applied topically once daily for either 28 or 56 consecutive days on psoriasis vulgaris affected skin on the face and on the intertriginous areas. The ointment was not to be applied in the 24-hour period before Day 28 and Day 56 to avoid interference from the hydrocortisone with the adrenocorticotrophic hormone (ACTH) challenge test. Treatment was to be resumed after Visit 3, where applicable. The face was defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead was to be estimated considering the standard or previous hairline. The intertriginous areas were defined as the axillae, the genito-femoral and inguinal folds, the inframammary folds, the intergluteal folds, and scrotum. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| At Week 4 and Week 8 |
| The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low. | At Week 4 and Week 8 |
| Serum Cortisol Concentration After 30 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. | At Week 4 and Week 8 |
| Serum Cortisol Concentration After 60 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. | At Week 4 and Week 8 |
| Change in Albumin Corrected Serum Calcium | Baseline was defined as the last assessment performed before study medication application. | From baseline to Week 2 and Week 6 |
| Albumin Corrected Serum Calcium | The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). | At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | The table summarizes the shifts in albumin corrected serum calcium versus the normal range. The end of treatment data was defined as the last value recorded for the parameter during the treatment phase of the study (i.e. Week 4, 6, or 8). The normal reference range for the albumin corrected serum calcium was defined as 2.1-2.64 mmol/L (8.4-10.6 mg/L). The value below this level was considered 'low', while the value above this range was considered 'high'. | At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | Controlled disease was defined as the following (P=Plaque thickening, S=Scaling, E=Erythema) Clear (Plaque thickening=no elevation/thickening of normal skin, S=no evidence of scaling, E= none/hyperpigmentation/residual red coloration) or Almost clear (P=none/possible thickening but difficult to ascertain whether there is a slight elevation above normal skin level, S=none/residual surface dryness and scaling, E=light pink coloration) (last value recorded i.e. Week 4, 6, or 8) | At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas | Controlled disease was defined as the following: Clear (Infiltration = no elevation or thickening of normal skin, Erythema = normal skin colour or hyperpigmentation) or Almost clear (Infiltration = no elevation or thickening of normal skin, Erythema = faint pink colour) The end of treatment data was defined as the last value recorded for the efficacy measure. | At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Overall Disease Severity of the Face According to the IGA | 6-category scale based on plaque thickening (P), Scaling (S), Erythema (E). Clear (P=no elevation/thickening of normal skin, S=no evidence of scaling, E=none/hyperpigmentation/residual red coloration) Almost clear (P=none/possible thickening but difficult to ascertain whether there is a slight elevation above normal skin level, S=none/residual surface dryness and scaling, E=light pink coloration) Mild (P=slight but definite elevation, S=fine scales partially/mostly covering lesions, E=light red coloration) Moderate (P=moderate elevation with rounded or sloped edges, S=most lesions at least partially covered, E=definite red coloration) Severe (P =marked elevation typically with hard or sharp edges, S=non-tenacious scale predominates, covering most or all of the lesions, E=very bright red coloration) Very severe (P=very marked elevation typically with hard or sharp edges, S=thick tenacious scale covers most or all of the lesions, E=extreme red coloration, deep red coloration) | At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Overall Disease Severity of Intertriginous Areas According to the IGA | The assessment of the disease severity of the intertriginous areas was made using the 6-category scale; clear, almost clear, mild, moderate, severe, very severe. Clear (Infiltration = no elevation or thickening of normal skin, Erythema = normal skin colour or hyperpigmentation) Almost clear (Infiltration = no elevation or thickening of normal skin, Erythema = faint pink colour) Mild (Infiltration = slight, subtle thickening or infiltration, only marginally increased from normal skin, Erythema = light pink colour) Moderate (Infiltration = palpable thickening or infiltration without elevation, Erythema = definite pink colour) Severe (Infiltration = palpable thickening or infiltration with elevation, Erythema = very bright red coloration) Very severe (Infiltration = marked thickening or infiltration with rounded or sloped edges, Erythema = bright deep red coloration) | At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Somerset Skin Center | Troy | Michigan | 48084 | United States |
| Psoriasis Treatment Center of Central NJ | East Windsor | New Jersey | 08520 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| The Guenther Dermatology Research Centre | London | Ontario | N6A3H7 | Canada |
| Institute of Clinical Pharmacology Parexel International Gmbh | Berlin | 12351 | Germany |
| LCG Bioscience | Bourn | Cambridge | CB3 7TR | United Kingdom |
| ICON Development Solutions | Manchester | M15 6SH | United Kingdom |
| The Dermatology Centre, Hope Hospital | Manchester | M6 8HD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcipotriol Plus Hydrocortisone (LEO 80190) | Calcipotriol plus hydrocortisone (LEO 80190): Once daily application |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low. | Per protocol analysis set (out of 33 participants who received treatment, 1 provided no ACTH challenge test data following start of treatment and 2 applied less than 1 gram of study treatment.) | Posted | Count of Participants | Participants | At Week 4 (Day 28) and Week 8 (Day 56) |
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| Primary | Change in Albumin Corrected Serum Calcium | Baseline was defined as the last assessment performed before study medication application. The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). | This evaluation was based on the safety analysis set that consists of all participants who received at least one application with study treatment (33 participants). The analysis only contains data from participants who attended the specific visits. | Posted | Mean | 95% Confidence Interval | mmol/L | From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
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| Secondary | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low. | Per protocol analysis set (out of 33 participants who received treatment, 1 provided no ACTH challenge test data following start of treatment and 2 applied less than 1 gram of study treatment.) | Posted | Count of Participants | Participants | At Week 4 and Week 8 |
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| Secondary | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low. | Per protocol analysis set (out of 33 participants who received treatment, 1 provided no ACTH challenge test data following start of treatment and 2 applied less than 1 gram of study treatment.) | Posted | Count of Participants | Participants | At Week 4 and Week 8 |
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| Secondary | Serum Cortisol Concentration After 30 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. | Per protocol analysis set (out of 33 participants who received treatment, 1 provided no ACTH challenge test data following start of treatment and 2 applied less than 1 gram of study treatment.) | Posted | Mean | Standard Deviation | mcg/dL | At Week 4 and Week 8 |
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| Secondary | Serum Cortisol Concentration After 60 Minutes | The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. | Per protocol analysis set (out of 33 participants who received treatment, 1 provided no ACTH challenge test data following start of treatment and 2 applied less than 1 gram of study treatment.) | Posted | Mean | Standard Deviation | mcg/dL | At Week 4 and Week 8 |
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| Secondary | Change in Albumin Corrected Serum Calcium | Baseline was defined as the last assessment performed before study medication application. | This evaluation was based on all participants who received at least one application with study treatments, thus 33 participants were analyzed. The table only contains data from participants who attended the specific visits. | Posted | Mean | Standard Deviation | mmol/L | From baseline to Week 2 and Week 6 |
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| Secondary | Albumin Corrected Serum Calcium | The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). | This evaluation was based on the safety analysis set that consists of all participants who received at least one application with study treatment (33 participants). The analysis only contains data from participants who attended the specific visits. | Posted | Mean | Standard Deviation | mmol/L | At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
|
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| Secondary | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | The table summarizes the shifts in albumin corrected serum calcium versus the normal range. The end of treatment data was defined as the last value recorded for the parameter during the treatment phase of the study (i.e. Week 4, 6, or 8). The normal reference range for the albumin corrected serum calcium was defined as 2.1-2.64 mmol/L (8.4-10.6 mg/L). The value below this level was considered 'low', while the value above this range was considered 'high'. | This evaluation was based on all participants who received at least one application with study treatments, thus 33 participants were analyzed. The table only contains data from participants who attended the specific visits. | Posted | Count of Participants | Participants | At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
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| Secondary | Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | Controlled disease was defined as the following (P=Plaque thickening, S=Scaling, E=Erythema) Clear (Plaque thickening=no elevation/thickening of normal skin, S=no evidence of scaling, E= none/hyperpigmentation/residual red coloration) or Almost clear (P=none/possible thickening but difficult to ascertain whether there is a slight elevation above normal skin level, S=none/residual surface dryness and scaling, E=light pink coloration) (last value recorded i.e. Week 4, 6, or 8) | This efficacy evaluation is based on the full analysis set that consists of all participants who received study treatment, thus 33 participants were analyzed. The analysis only contains data from participants who attended the specific visits. | Posted | Count of Participants | Participants | At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
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| Secondary | Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas | Controlled disease was defined as the following: Clear (Infiltration = no elevation or thickening of normal skin, Erythema = normal skin colour or hyperpigmentation) or Almost clear (Infiltration = no elevation or thickening of normal skin, Erythema = faint pink colour) The end of treatment data was defined as the last value recorded for the efficacy measure. | This efficacy evaluation is based on the full analysis set that consists of all participants who received study treatment, thus 33 participants were analyzed. The analysis only contains data from participants who attended the specific visits. | Posted | Count of Participants | Participants | At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
|
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| Secondary | Overall Disease Severity of the Face According to the IGA | 6-category scale based on plaque thickening (P), Scaling (S), Erythema (E). Clear (P=no elevation/thickening of normal skin, S=no evidence of scaling, E=none/hyperpigmentation/residual red coloration) Almost clear (P=none/possible thickening but difficult to ascertain whether there is a slight elevation above normal skin level, S=none/residual surface dryness and scaling, E=light pink coloration) Mild (P=slight but definite elevation, S=fine scales partially/mostly covering lesions, E=light red coloration) Moderate (P=moderate elevation with rounded or sloped edges, S=most lesions at least partially covered, E=definite red coloration) Severe (P =marked elevation typically with hard or sharp edges, S=non-tenacious scale predominates, covering most or all of the lesions, E=very bright red coloration) Very severe (P=very marked elevation typically with hard or sharp edges, S=thick tenacious scale covers most or all of the lesions, E=extreme red coloration, deep red coloration) | A participant was to leave the study if he/she was clear according to the IGA of the face and after 4 weeks of treatment. Participants who still had psoriasis on the face after 4 weeks of treatment continued treatment for another 4-week period. | Posted | Count of Participants | Participants | At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
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| Secondary | Overall Disease Severity of Intertriginous Areas According to the IGA | The assessment of the disease severity of the intertriginous areas was made using the 6-category scale; clear, almost clear, mild, moderate, severe, very severe. Clear (Infiltration = no elevation or thickening of normal skin, Erythema = normal skin colour or hyperpigmentation) Almost clear (Infiltration = no elevation or thickening of normal skin, Erythema = faint pink colour) Mild (Infiltration = slight, subtle thickening or infiltration, only marginally increased from normal skin, Erythema = light pink colour) Moderate (Infiltration = palpable thickening or infiltration without elevation, Erythema = definite pink colour) Severe (Infiltration = palpable thickening or infiltration with elevation, Erythema = very bright red coloration) Very severe (Infiltration = marked thickening or infiltration with rounded or sloped edges, Erythema = bright deep red coloration) | A participant was to leave the study if they were clear according to the IGA of the intertriginous after 4 weeks of treatment. Participants who still had psoriasis on the intertriginous areas after 4 weeks of treatment continued treatment for another 4-week period. | Posted | Count of Participants | Participants | At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) |
|
From baseline visit (Day -7 to -3) to Follow-up 1 (end of treatment +14 ± 2) and Follow-up 2 (end of treatment +28 ± 2).
Follow-up 1 was only applicable if an adverse event (AE, serious or non-serious) classified as possibly or probably related to the study medication or not assessable in relation to the study medication was present at the participant's last on-treatment visit. This follow-up had to be performed 14 ±2 days after the participant's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
Follow-up 2 was only applicable in case of possible HPA axis suppression.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcipotriol Plus Hydrocortisone (LEO 80190) | Calcipotriol plus hydrocortisone (LEO 80190): Once daily application | 0 | 33 | 0 | 33 | 15 | 33 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Application site burning | General disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (6.1) | Non-systematic Assessment |
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The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
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| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
| Moderate |
|
| Severe |
|
| Very severe |
|