Psoriasis Vulgaris
Conditions
Brief summary
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
Interventions
Once daily application
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginous areas * Clinical diagnosis of psoriasis vulgaris on the trunk and/or limbs or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs * An extent of psoriatic involvement on the face of at least 5 cm2 and the sum of all facial and intertriginous lesions at least 30 cm2 * Treatment areas (face and intertriginous) amenable to topical treatment with a maximum of 100g ointment per week * Disease severity of the face and intertriginous areas graded as moderate, severe or very severe according to the investigator´s global assessment of disease severity * Patients with a normal HPA axis function: serum cortisol concentration above 5 mcg/dl before adrenocorticotropic hormone (ACTH: tetracosactid/cosyntropin) injection and serum cortisol concentration above 18 mcg/dl 30 min after ACTH (tetracosactid/cosyntropin) injection * Albumin corrected serum calcium within reference range * Females of childbearing potential have to use a highly effective method of contraception during the study (hormonal contraceptives on oestrogen basis are not allowed)
Exclusion criteria
* A history of active allergy, asthma, allergic skin rash, or sensitivity to any medication (including ACTH/tetracosactid/cosyntropin) or to any component of the formulations being tested * Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (eg vitamin D analogues, retinoids)within 2 weeks prior to Visit 1. Stable treatment with methotrexate or fumaric acid is allowed * Systemic treatment with corticosteroids within 12 weeks prior to Visit 1 * Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (eg. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to Visit 1 * Psoralen plus ultraviolet light A (PUVA) therapy or Grenz ray therapy within 4 weeks prior to Visit 1 * Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1 * Topical treatment with World Health Organization (WHO) group 2, 3 or 4 corticosteroids within 4 weeks prior to Visit 1 * Topical treatment with WHO group 1 corticosteroids within 2 weeks prior to Visit 1 * Any topical treatment of the face and intertriginous areas (except for emollients) within 2 weeks prior to Visit 1 * Oestrogen therapy or any other medication known to affect cortisol levels or HPA-axis integrity within 4 weeks prior to Visit 1 * Enzymatic inductors, systemic or topical cytochrome P450 inhibitors, hypoglycaemic sulfonamides or antidepressive medication within 4 weeks prior to Visit 1 * Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis * Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds * Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas * Planned exposure to sun, Ultraviolet A (UVA) or UVB during the study that may affect the psoriasis vulgaris * Clinical signs or symptoms of Cushing´s disease or Addison's disease * Known or suspected severe renal insufficiency or severe hepatic disorders * Known or suspected disorders of calcium metabolism associated with hypercalcaemia * Known or suspected endocrine disorder that may affect the results of the ACTH challenge test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes | At Week 4 (Day 28) and Week 8 (Day 56) | 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. |
| Change in Albumin Corrected Serum Calcium | From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Cortisol Concentration After 30 Minutes | At Week 4 and Week 8 | 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. |
| Serum Cortisol Concentration After 60 Minutes | At Week 4 and Week 8 | 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. |
| Change in Albumin Corrected Serum Calcium | From baseline to Week 2 and Week 6 | Baseline was defined as the last assessment performed before study medication application. |
| Albumin Corrected Serum Calcium | At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) | The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8). |
| The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes | At Week 4 and Week 8 | 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. |
| Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) | 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) |
| Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) | 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. |
| Overall Disease Severity of the Face According to the IGA | At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) | 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) |
| Overall Disease Severity of Intertriginous Areas According to the IGA | At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8) | 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) |
| Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8) | 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'. |
| The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes | At Week 4 and Week 8 | 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. |
Countries
Canada, Germany, United Kingdom, United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) Calcipotriol plus hydrocortisone (LEO 80190): Once daily application | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Calcipotriol Plus Hydrocortisone (LEO 80190) |
|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 15.9 |
| Region of Enrollment Canada | 8 participants |
| Region of Enrollment Germany | 7 participants |
| Region of Enrollment United Kingdom | 11 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 15 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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).
Time frame: From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | End of Treatment (last value recorded) | -0.033 mmol/L |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | Baseline | 2.215 mmol/L |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | Week 4 (Day 28) | 0.002 mmol/L |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | Week 8 (Day 56) | -0.045 mmol/L |
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.
Time frame: At Week 4 (Day 28) and Week 8 (Day 56)
Population: 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.)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes | >18 mcg/dL | 29 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes | ≤18 mcg/dL | 1 Participants |
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).
Time frame: At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium | Week 2 (Day 14) | 2.233 mmol/L | Standard Deviation 0.079 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium | Week 4 (Day 28) | 2.217 mmol/L | Standard Deviation 0.074 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium | Week 6 (Day 42) | 2.208 mmol/L | Standard Deviation 0.096 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium | Week 8 (Day 56) | 2.179 mmol/L | Standard Deviation 0.085 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium | End of Treatment (last value recorded) | 2.182 mmol/L | Standard Deviation 0.081 |
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'.
Time frame: At Week 2, Week 4, Week 6 and Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 2 (Day 14) | Low | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 2 (Day 14) | Normal | 30 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 2 (Day 14) | High | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 4 (Day 28) | Low | 3 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 4 (Day 28) | Normal | 30 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 4 (Day 28) | High | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 6 (Day 42) | Low | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 6 (Day 42) | Normal | 26 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 6 (Day 42) | High | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 8 (Day 56) | Low | 6 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 8 (Day 56) | Normal | 21 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | Week 8 (Day 56) | High | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | End of Treatment (last value recorded) | Low | 6 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | End of Treatment (last value recorded) | Normal | 27 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range | End of Treatment (last value recorded) | High | 0 Participants |
Secondary
Change in Albumin Corrected Serum Calcium
Baseline was defined as the last assessment performed before study medication application.
Time frame: From baseline to Week 2 and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | Baseline | 2.215 mmol/L | Standard Deviation 0.077 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | Week 2 (Day 14) | 0.018 mmol/L | Standard Deviation 0.095 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Change in Albumin Corrected Serum Calcium | Week 6 (Day 42) | -0.013 mmol/L | Standard Deviation 0.083 |
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)
Time frame: At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Baseline | Clear | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Baseline | Almost clear | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Baseline | Mild | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Baseline | Moderate | 19 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Baseline | Severe | 12 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Baseline | Very severe | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 2 (Day 14) | Clear | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 2 (Day 14) | Almost clear | 7 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 2 (Day 14) | Mild | 16 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 2 (Day 14) | Moderate | 9 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 2 (Day 14) | Severe | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 2 (Day 14) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 4 (Day 28) | Clear | 5 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 4 (Day 28) | Almost clear | 15 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 4 (Day 28) | Mild | 10 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 4 (Day 28) | Moderate | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 4 (Day 28) | Severe | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 4 (Day 28) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 6 (Day 42) | Clear | 4 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 6 (Day 42) | Almost clear | 17 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 6 (Day 42) | Mild | 5 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 6 (Day 42) | Moderate | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 6 (Day 42) | Severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 6 (Day 42) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 8 (Day 56) | Clear | 7 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 8 (Day 56) | Almost clear | 12 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 8 (Day 56) | Mild | 7 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 8 (Day 56) | Moderate | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 8 (Day 56) | Severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | Week 8 (Day 56) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | End of Treatment (last value recorded) | Clear | 10 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | End of Treatment (last value recorded) | Almost clear | 13 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | End of Treatment (last value recorded) | Mild | 7 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | End of Treatment (last value recorded) | Moderate | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | End of Treatment (last value recorded) | Severe | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of Intertriginous Areas According to the IGA | End of Treatment (last value recorded) | Very severe | 0 Participants |
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)
Time frame: At baseline, Week 2, Week 4, Week 6, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Baseline | Clear | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Baseline | Almost clear | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Baseline | Mild | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Baseline | Moderate | 27 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Baseline | Severe | 6 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Baseline | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 2 (Day 14) | Clear | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 2 (Day 14) | Almost clear | 12 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 2 (Day 14) | Mild | 15 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 2 (Day 14) | Moderate | 5 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 2 (Day 14) | Severe | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 2 (Day 14) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 4 (Day 28) | Clear | 5 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 4 (Day 28) | Almost clear | 16 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 4 (Day 28) | Mild | 9 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 4 (Day 28) | Moderate | 2 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 4 (Day 28) | Severe | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 4 (Day 28) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 6 (Day 42) | Clear | 5 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 6 (Day 42) | Almost clear | 15 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 6 (Day 42) | Mild | 7 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 6 (Day 42) | Moderate | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 6 (Day 42) | Severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 6 (Day 42) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 8 (Day 56) | Clear | 5 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 8 (Day 56) | Almost clear | 14 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 8 (Day 56) | Mild | 6 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 8 (Day 56) | Moderate | 3 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 8 (Day 56) | Severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | Week 8 (Day 56) | Very severe | 0 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | End of Treatment (last value recorded) | Clear | 9 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | End of Treatment (last value recorded) | Almost clear | 14 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | End of Treatment (last value recorded) | Mild | 6 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | End of Treatment (last value recorded) | Moderate | 3 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | End of Treatment (last value recorded) | Severe | 1 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Overall Disease Severity of the Face According to the IGA | End of Treatment (last value recorded) | Very severe | 0 Participants |
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.
Time frame: At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | Week 4 (Day 28) | Controlled | 20 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | Week 4 (Day 28) | Non-controlled | 13 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | Week 8 (Day 56) | Controlled | 19 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | Week 8 (Day 56) | Non-controlled | 9 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | End of Treatment (last value recorded) | Controlled | 23 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the IGA of the Intertriginous Areas | End of Treatment (last value recorded) | Non-controlled | 10 Participants |
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)
Time frame: At Week 4, Week 8 and end of treatment (last value recorded i.e. Week 4, 6, or 8)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | Week 4 (Day 28) | Controlled | 21 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | Week 4 (Day 28) | Non-controlled | 12 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | Week 8 (Day 56) | Controlled | 19 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | Week 8 (Day 56) | Non-controlled | 9 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | End of Treatment (last value recorded) | Controlled | 23 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Participants With Controlled Disease (Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity (IGA) of the Face | End of Treatment (last value recorded) | Non-controlled | 10 Participants |
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.
Time frame: At Week 4 and Week 8
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Serum Cortisol Concentration After 30 Minutes | Week 4 (Day 28) | 25.29 mcg/dL | Standard Deviation 4.35 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Serum Cortisol Concentration After 30 Minutes | Week 8 (Day 56) | 25.93 mcg/dL | Standard Deviation 4.73 |
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.
Time frame: At Week 4 and Week 8
Population: 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.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Serum Cortisol Concentration After 60 Minutes | Week 4 (Day 28) | 28.81 mcg/dL | Standard Deviation 3.48 |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | Serum Cortisol Concentration After 60 Minutes | Week 8 (Day 56) | 28.82 mcg/dL | Standard Deviation 5.3 |
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.
Time frame: At Week 4 and Week 8
Population: 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.)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes | >18 mcg/dL | 29 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes | ≤18 mcg/dL | 1 Participants |
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.
Time frame: At Week 4 and Week 8
Population: 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.)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calcipotriol Plus Hydrocortisone (LEO 80190) | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes | >18 mcg/dL | 30 Participants |
| Calcipotriol Plus Hydrocortisone (LEO 80190) | The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes | ≤18 mcg/dL | 0 Participants |