Trial Outcomes & Findings for Effect of Calcipotriol Plus Hydrocortisone Ointment on the Adrenal Hormone Balance and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and Skin Folds (NCT NCT00704262)

Last Updated: 2025-03-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

At Week 4 (Day 28) and Week 8 (Day 56)

Results posted on

2025-03-07

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Calcipotriol Plus Hydrocortisone Ointment on the Adrenal Hormone Balance and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and Skin Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Age, Continuous	47.4 years STANDARD_DEVIATION 15.9 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	19 Participants n=99 Participants
Region of Enrollment Canada	8 participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants
Region of Enrollment United Kingdom	11 participants n=99 Participants
Region of Enrollment Germany	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.)

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=30 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
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
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

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Change in Albumin Corrected Serum Calcium Baseline	2.215 mmol/L Interval 2.188 to 2.243
Change in Albumin Corrected Serum Calcium Week 4 (Day 28)	0.002 mmol/L Interval -0.026 to 0.029
Change in Albumin Corrected Serum Calcium Week 8 (Day 56)	-0.045 mmol/L Interval -0.083 to -0.007
Change in Albumin Corrected Serum Calcium End of Treatment (last value recorded)	-0.033 mmol/L Interval -0.066 to 0.0

SECONDARY outcome

Timeframe: At Week 4 and Week 8

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=30 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes >18 mcg/dL	29 Participants
The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes ≤18 mcg/dL	1 Participants

SECONDARY outcome

Timeframe: At Week 4 and Week 8

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=30 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes >18 mcg/dL	30 Participants
The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes ≤18 mcg/dL	0 Participants

SECONDARY outcome

Timeframe: At Week 4 and Week 8

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=30 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Serum Cortisol Concentration After 30 Minutes Week 4 (Day 28)	25.29 mcg/dL Standard Deviation 4.35
Serum Cortisol Concentration After 30 Minutes Week 8 (Day 56)	25.93 mcg/dL Standard Deviation 4.73

SECONDARY outcome

Timeframe: At Week 4 and Week 8

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=30 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Serum Cortisol Concentration After 60 Minutes Week 4 (Day 28)	28.81 mcg/dL Standard Deviation 3.48
Serum Cortisol Concentration After 60 Minutes Week 8 (Day 56)	28.82 mcg/dL Standard Deviation 5.30

SECONDARY outcome

Timeframe: 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.

Baseline was defined as the last assessment performed before study medication application.

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Change in Albumin Corrected Serum Calcium Baseline	2.215 mmol/L Standard Deviation 0.077
Change in Albumin Corrected Serum Calcium Week 2 (Day 14)	0.018 mmol/L Standard Deviation 0.095
Change in Albumin Corrected Serum Calcium Week 6 (Day 42)	-0.013 mmol/L Standard Deviation 0.083

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Albumin Corrected Serum Calcium Week 2 (Day 14)	2.233 mmol/L Standard Deviation 0.079
Albumin Corrected Serum Calcium Week 4 (Day 28)	2.217 mmol/L Standard Deviation 0.074
Albumin Corrected Serum Calcium Week 6 (Day 42)	2.208 mmol/L Standard Deviation 0.096
Albumin Corrected Serum Calcium Week 8 (Day 56)	2.179 mmol/L Standard Deviation 0.085
Albumin Corrected Serum Calcium End of Treatment (last value recorded)	2.182 mmol/L Standard Deviation 0.081

SECONDARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 8 (Day 56) · Normal	21 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 8 (Day 56) · High	0 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 2 (Day 14) · Low	2 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 2 (Day 14) · Normal	30 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 2 (Day 14) · High	0 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 4 (Day 28) · Low	3 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 4 (Day 28) · Normal	30 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 4 (Day 28) · High	0 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 6 (Day 42) · Low	2 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 6 (Day 42) · Normal	26 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 6 (Day 42) · High	0 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range Week 8 (Day 56) · Low	6 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range End of Treatment (last value recorded) · Low	6 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range End of Treatment (last value recorded) · Normal	27 Participants
Albumin Corrected Serum Calcium Values Above the Upper Limit of the Reference Range End of Treatment (last value recorded) · High	0 Participants

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
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
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
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
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
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
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
Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas Week 4 (Day 28) · Controlled	20 Participants
Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas Week 4 (Day 28) · Non-controlled	13 Participants
Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas Week 8 (Day 56) · Controlled	19 Participants
Participants With "Controlled Disease" ("Clear" or "Almost Clear") According to the IGA of the Intertriginous Areas Week 8 (Day 56) · Non-controlled	9 Participants
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

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Overall Disease Severity of the Face According to the IGA Week 2 (Day 14) · Severe	1 Participants
Overall Disease Severity of the Face According to the IGA Week 6 (Day 42) · Almost clear	15 Participants
Overall Disease Severity of the Face According to the IGA Baseline · Clear	0 Participants
Overall Disease Severity of the Face According to the IGA Baseline · Almost clear	0 Participants
Overall Disease Severity of the Face According to the IGA Baseline · Mild	0 Participants
Overall Disease Severity of the Face According to the IGA Baseline · Moderate	27 Participants
Overall Disease Severity of the Face According to the IGA Baseline · Severe	6 Participants
Overall Disease Severity of the Face According to the IGA Baseline · Very severe	0 Participants
Overall Disease Severity of the Face According to the IGA Week 2 (Day 14) · Clear	0 Participants
Overall Disease Severity of the Face According to the IGA Week 2 (Day 14) · Almost clear	12 Participants
Overall Disease Severity of the Face According to the IGA Week 2 (Day 14) · Mild	15 Participants
Overall Disease Severity of the Face According to the IGA Week 2 (Day 14) · Moderate	5 Participants
Overall Disease Severity of the Face According to the IGA Week 2 (Day 14) · Very severe	0 Participants
Overall Disease Severity of the Face According to the IGA Week 4 (Day 28) · Clear	5 Participants
Overall Disease Severity of the Face According to the IGA Week 4 (Day 28) · Almost clear	16 Participants
Overall Disease Severity of the Face According to the IGA Week 4 (Day 28) · Mild	9 Participants
Overall Disease Severity of the Face According to the IGA Week 4 (Day 28) · Moderate	2 Participants
Overall Disease Severity of the Face According to the IGA Week 4 (Day 28) · Severe	1 Participants
Overall Disease Severity of the Face According to the IGA Week 4 (Day 28) · Very severe	0 Participants
Overall Disease Severity of the Face According to the IGA Week 6 (Day 42) · Clear	5 Participants
Overall Disease Severity of the Face According to the IGA Week 6 (Day 42) · Mild	7 Participants
Overall Disease Severity of the Face According to the IGA Week 6 (Day 42) · Moderate	1 Participants
Overall Disease Severity of the Face According to the IGA Week 6 (Day 42) · Severe	0 Participants
Overall Disease Severity of the Face According to the IGA Week 6 (Day 42) · Very severe	0 Participants
Overall Disease Severity of the Face According to the IGA Week 8 (Day 56) · Clear	5 Participants
Overall Disease Severity of the Face According to the IGA Week 8 (Day 56) · Almost clear	14 Participants
Overall Disease Severity of the Face According to the IGA Week 8 (Day 56) · Mild	6 Participants
Overall Disease Severity of the Face According to the IGA Week 8 (Day 56) · Moderate	3 Participants
Overall Disease Severity of the Face According to the IGA Week 8 (Day 56) · Severe	0 Participants
Overall Disease Severity of the Face According to the IGA Week 8 (Day 56) · Very severe	0 Participants
Overall Disease Severity of the Face According to the IGA End of Treatment (last value recorded) · Clear	9 Participants
Overall Disease Severity of the Face According to the IGA End of Treatment (last value recorded) · Almost clear	14 Participants
Overall Disease Severity of the Face According to the IGA End of Treatment (last value recorded) · Mild	6 Participants
Overall Disease Severity of the Face According to the IGA End of Treatment (last value recorded) · Moderate	3 Participants
Overall Disease Severity of the Face According to the IGA End of Treatment (last value recorded) · Severe	1 Participants
Overall Disease Severity of the Face According to the IGA End of Treatment (last value recorded) · Very severe	0 Participants

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 Participants Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Overall Disease Severity of Intertriginous Areas According to the IGA Week 6 (Day 42) · Severe	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Baseline · Clear	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Baseline · Almost clear	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Baseline · Mild	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Baseline · Moderate	19 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Baseline · Severe	12 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Baseline · Very severe	2 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 2 (Day 14) · Clear	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 2 (Day 14) · Almost clear	7 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 2 (Day 14) · Mild	16 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 2 (Day 14) · Moderate	9 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 2 (Day 14) · Severe	1 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 2 (Day 14) · Very severe	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 4 (Day 28) · Clear	5 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 4 (Day 28) · Almost clear	15 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 4 (Day 28) · Mild	10 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 4 (Day 28) · Moderate	2 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 4 (Day 28) · Severe	1 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 4 (Day 28) · Very severe	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 6 (Day 42) · Clear	4 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 6 (Day 42) · Almost clear	17 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 6 (Day 42) · Mild	5 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 6 (Day 42) · Moderate	2 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 6 (Day 42) · Very severe	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 8 (Day 56) · Clear	7 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 8 (Day 56) · Almost clear	12 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 8 (Day 56) · Mild	7 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 8 (Day 56) · Moderate	2 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 8 (Day 56) · Severe	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA Week 8 (Day 56) · Very severe	0 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA End of Treatment (last value recorded) · Clear	10 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA End of Treatment (last value recorded) · Almost clear	13 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA End of Treatment (last value recorded) · Mild	7 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA End of Treatment (last value recorded) · Moderate	2 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA End of Treatment (last value recorded) · Severe	1 Participants
Overall Disease Severity of Intertriginous Areas According to the IGA End of Treatment (last value recorded) · Very severe	0 Participants

Adverse Events

Calcipotriol Plus Hydrocortisone (LEO 80190)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Calcipotriol Plus Hydrocortisone (LEO 80190) n=33 participants at risk Calcipotriol plus hydrocortisone (LEO 80190): Once daily application
Blood and lymphatic system disorders Lymphadenopathy	3.0% 1/33 • 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.
Ear and labyrinth disorders Ear disorder	3.0% 1/33 • 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.
Gastrointestinal disorders Irritable bowel syndrome	3.0% 1/33 • 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.
Gastrointestinal disorders Nausea	6.1% 2/33 • 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.
General disorders Application site burning	3.0% 1/33 • 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.
General disorders Application site pruritus	3.0% 1/33 • 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.
Infections and infestations Bronchitis	3.0% 1/33 • 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.
Infections and infestations Nasopharyngitis	9.1% 3/33 • 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.
Infections and infestations Otitis externa	3.0% 1/33 • 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.
Infections and infestations Pharyngitis	3.0% 1/33 • 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.
Injury, poisoning and procedural complications Face injury	3.0% 1/33 • 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.
Injury, poisoning and procedural complications Joint sprain	3.0% 1/33 • 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.
Injury, poisoning and procedural complications Ligament injury	3.0% 1/33 • 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.
Metabolism and nutrition disorders Gout	3.0% 1/33 • 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.
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • 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.
Musculoskeletal and connective tissue disorders Groin pain	3.0% 1/33 • 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.
Musculoskeletal and connective tissue disorders Joint stiffness	3.0% 1/33 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	3.0% 1/33 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	3.0% 1/33 • 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.
Nervous system disorders Dizziness	3.0% 1/33 • 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.
Nervous system disorders Headache	12.1% 4/33 • 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.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.0% 1/33 • 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.
Skin and subcutaneous tissue disorders Pruritus	3.0% 1/33 • 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.
Vascular disorders Hypertension	3.0% 1/33 • 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.

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER