Trial Outcomes & Findings for An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects (NCT NCT02038569)

NCT ID: NCT02038569

Last Updated: 2025-03-10

Results Overview

Number of Adverse Drug Reactions (ADRs)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 125 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-03-10

Participant Flow

Participant milestones

Measure	LEO 80185 Gel LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Overall Study STARTED	107
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects

Baseline characteristics by cohort

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.
Age, Continuous	14.2 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	97 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants
Region of Enrollment Romania	42 participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Region of Enrollment Poland	14 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants
Region of Enrollment France	5 participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants
Fitzpatrick Skin Type Type I	2 Participants n=5 Participants
Fitzpatrick Skin Type Type II	47 Participants n=5 Participants
Fitzpatrick Skin Type Type III	34 Participants n=5 Participants
Fitzpatrick Skin Type Type IV	20 Participants n=5 Participants
Fitzpatrick Skin Type Type V	2 Participants n=5 Participants
Fitzpatrick Skin Type Type VI	2 Participants n=5 Participants
Duration of psoriasis vulgaris	4.1 years STANDARD_DEVIATION 3.2 • n=5 Participants
Investigator's global assessment of disease severity on body Mild	14 Participants n=5 Participants
Investigator's global assessment of disease severity on body Moderate	87 Participants n=5 Participants
Investigator's global assessment of disease severity on body Severe	6 Participants n=5 Participants
Psoriasis Area and Severity Index Score	10.70 score on a scale STANDARD_DEVIATION 4.41 • n=5 Participants
Investigator's assessment of extent of psoriasis on the body and scalp (%)	14.9 % of body surface area affected STANDARD_DEVIATION 8.3 • n=5 Participants
Patient's global assessment of disease severity on body Very Mild	5 Participants n=5 Participants
Patient's global assessment of disease severity on body Mild	21 Participants n=5 Participants
Patient's global assessment of disease severity on body Moderate	77 Participants n=5 Participants
Patient's global assessment of disease severity on body Severe	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis set

Number of Adverse Drug Reactions (ADRs)

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Adverse Drug Reactions (ADRs) Blood cortisol decreased	2 Number of adverse drug reactions
Adverse Drug Reactions (ADRs) Blood parathyroid hormone increased	1 Number of adverse drug reactions
Adverse Drug Reactions (ADRs) Acne	1 Number of adverse drug reactions
Adverse Drug Reactions (ADRs) Erythema	1 Number of adverse drug reactions
Adverse Drug Reactions (ADRs) Hyperparathyroidism	1 Number of adverse drug reactions
Adverse Drug Reactions (ADRs) Folliculitis	1 Number of adverse drug reactions
Adverse Drug Reactions (ADRs) Headache	1 Number of adverse drug reactions

PRIMARY outcome

Timeframe: 30 minutes after ACTH-challenge at Week 4

Population: Per protocol analysis set

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4

Outcome measures

Measure	LEO 80185 Gel n=31 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 Serum cortisol equal to or below 18 mcg/dL	4 Participants
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 Serum cortisol above 18 mcg/dL	27 Participants

PRIMARY outcome

Timeframe: 30 minutes after ACTH-challenge at Week 8

Population: Per protocol analysis set

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8

Outcome measures

Measure	LEO 80185 Gel n=31 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8 Serum cortisol equal to or below 18 mcg/dL	2 Participants
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8 Serum cortisol above 18 mcg/dL	27 Participants
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8 No assessment performed	2 Participants

PRIMARY outcome

Timeframe: From baseline to Week 4

Population: Safety analysis set.

Change in albumin-corrected serum calcium from baseline to Week 4

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Albumin-corrected Serum Calcium From Baseline to Week 4	-0.012 mmol/L Standard Deviation 0.131

PRIMARY outcome

Timeframe: From baseline to Week 8

Population: Safety analysis set.

Change in albumin-corrected serum calcium from baseline to Week 8

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Albumin-corrected Serum Calcium From Baseline to Week 8	-0.008 mmol/L Standard Deviation 0.125

PRIMARY outcome

Timeframe: From baseline to end of treatment

Population: Safety analysis set.

Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment	-0.003 mmol/L Standard Deviation 0.121

PRIMARY outcome

Timeframe: From baseline to Week 4

Population: Safety analysis set

Change in 24-hour urinary calcium excretion from baseline to Week 4

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4	-0.493 mmol/24hr Standard Deviation 1.669

PRIMARY outcome

Timeframe: From baseline to Week 8

Population: Safety analysis set

Change in 24-hour urinary calcium excretion from baseline to Week 8

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8	0.040 mmol/24hr Standard Deviation 1.638

PRIMARY outcome

Timeframe: From baseline to end of treatment

Population: Safety analysis set

Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment	0.069 mmol/24hr Standard Deviation 1.593

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety analysis set

Number of Adverse Events (AEs)

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Adverse Events (AEs) Nasopharyngitis	6 Adverse Events
Adverse Events (AEs) Rhinitis	2 Adverse Events
Adverse Events (AEs) Folliculitis	1 Adverse Events
Adverse Events (AEs) Hordeolum	1 Adverse Events
Adverse Events (AEs) Impetigo	1 Adverse Events
Adverse Events (AEs) Peritonsillar abscess	1 Adverse Events
Adverse Events (AEs) Upper respiratory tract infection	1 Adverse Events
Adverse Events (AEs) Viral infection	1 Adverse Events
Adverse Events (AEs) Blood parathyroid hormone increased	5 Adverse Events
Adverse Events (AEs) Blood cortisol decreased	2 Adverse Events
Adverse Events (AEs) Eosinophil count increased	1 Adverse Events
Adverse Events (AEs) Headache	8 Adverse Events
Adverse Events (AEs) Balance disorder	1 Adverse Events
Adverse Events (AEs) Dizziness	1 Adverse Events
Adverse Events (AEs) Syncope	1 Adverse Events
Adverse Events (AEs) Cough	2 Adverse Events
Adverse Events (AEs) Oropharyngeal pain	2 Adverse Events
Adverse Events (AEs) Dyspnoea	1 Adverse Events
Adverse Events (AEs) Epistaxis	1 Adverse Events
Adverse Events (AEs) Respiratory disorder	1 Adverse Events
Adverse Events (AEs) Acne	1 Adverse Events
Adverse Events (AEs) Erythema	1 Adverse Events
Adverse Events (AEs) Pruritus	1 Adverse Events
Adverse Events (AEs) Sunburn	1 Adverse Events
Adverse Events (AEs) Abdominal pain upper	1 Adverse Events
Adverse Events (AEs) Constipation	1 Adverse Events
Adverse Events (AEs) Diarrhoea	1 Adverse Events
Adverse Events (AEs) Back pain	1 Adverse Events
Adverse Events (AEs) Muscle spasms	1 Adverse Events
Adverse Events (AEs) Musculoskeletal chest pain	1 Adverse Events
Adverse Events (AEs) Neck pain	1 Adverse Events
Adverse Events (AEs) Dysmenorrhoea	3 Adverse Events
Adverse Events (AEs) Arthropod sting	1 Adverse Events
Adverse Events (AEs) Concussion	1 Adverse Events
Adverse Events (AEs) Sleep disorder	1 Adverse Events
Adverse Events (AEs) Suicide attempt	1 Adverse Events
Adverse Events (AEs) Cardiovascular disorder	1 Adverse Events
Adverse Events (AEs) Hyperparathyroidism	1 Adverse Events
Adverse Events (AEs) Iron deficiency	1 Adverse Events
Adverse Events (AEs) Wisdom teeth removal	1 Adverse Events

SECONDARY outcome

Timeframe: 30 and 60 minutes after ACTH-challenge at Week 4

Population: Per protocol analysis set

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4

Outcome measures

Measure	LEO 80185 Gel n=31 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4 Serum cortisol equal to or below 18 mcg/dL	0 Participants
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4 Serum cortisol above 18 mcg/dL	31 Participants

SECONDARY outcome

Timeframe: 30 and 60 minutes after ACTH-challenge at Week 8

Population: Per protocol analysis set

Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 8

Outcome measures

Measure	LEO 80185 Gel n=31 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8 Serum cortisol equal to or below 18 mcg/dL	0 Participants
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8 Serum cortisol above 18 mcg/dL	29 Participants
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8 No assessment performed	2 Participants

SECONDARY outcome

Timeframe: From baseline to Week 4

Population: Safety analysis set

Change in urinary calcium:creatinine ratio from baseline to Week 4

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4	-0.098 mmol/g Standard Deviation 1.642

SECONDARY outcome

Timeframe: From baseline to Week 8

Population: Safety analysis set

Change in urinary calcium:creatinine ratio from baseline to Week 8

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8	0.219 mmol/g Standard Deviation 1.700

SECONDARY outcome

Timeframe: From baseline to Week 4

Population: Safety analysis set

Change in serum alkaline phosphatase from baseline to Week 4

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Serum Alkaline Phosphatase From Baseline to Week 4	-0.4 mmol/L Standard Deviation 31.4

SECONDARY outcome

Timeframe: From baseline to Week 8

Population: Safety analysis set

Change in serum alkaline phosphatase from baseline to Week 8

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Change in Serum Alkaline Phosphatase From Baseline to Week 8	-6.8 mmol/L Standard Deviation 42.6

SECONDARY outcome

Timeframe: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

Population: PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

AUC(0-t) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-t) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-t). The mean value of AUC(0-t) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

Outcome measures

Measure	LEO 80185 Gel n=32 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Pharmacokinetic Evaluation AUC(0-t) Betamethasone dipropionate	NA pg*h/mL Standard Deviation NA Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, therefore it was not possible to calculate AUC(0-t).
Pharmacokinetic Evaluation AUC(0-t) Betamethasone 17-propionate	325 pg*h/mL Standard Deviation 193.75

SECONDARY outcome

Timeframe: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

Population: PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

AUC(0-infinity) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-infinity) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-infinity). The mean value of AUC(0-infinity) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

The terms AUC(0-infinity) and AUC(all) are interchangeable, AUC(0-infinity) was used in the protocol whereas AUC(all) was used in the report. AUC(0-infinity) has been used here to be consistent with the protocol.

Outcome measures

Measure	LEO 80185 Gel n=32 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Pharmacokinetic Evaluation AUC(0-infinity) Betamethasone dipropionate	NA pg*h/mL Standard Deviation NA Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, therefore it was not possible to calculate AUC(0-infinity).
Pharmacokinetic Evaluation AUC(0-infinity) Betamethasone 17-propionate	325 pg*h/mL Standard Deviation 193.75

SECONDARY outcome

Timeframe: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

Population: PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

C(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore pharmacokinetic profiles could not be calculated. Presented C(max) values for betamethasone dipropionate and betamethasone 17-propionate are the the single highest concentrations measured in any sample at any time. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

Outcome measures

Measure	LEO 80185 Gel n=32 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Pharmacokinetic Evaluation C(Max) Betamethasone dipropionate	104 pg/mL
Pharmacokinetic Evaluation C(Max) Betamethasone 17-propionate	126 pg/mL

SECONDARY outcome

Timeframe: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

Population: PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

T(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects. Therefore it was not possible to calculate T(max) for betamethasone dipropionate and betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

Outcome measures

Measure	LEO 80185 Gel n=32 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Pharmacokinetic Evaluation T(Max) Betamethasone dipropionate	NA h Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, therefore it was not possible to calculate T(max).
Pharmacokinetic Evaluation T(Max) Betamethasone 17-propionate	NA h Betamethasone 17-propionate was only detected above lower limit of quantification in 12 samples from 5 subjects, therefore it was not possible to calculate T(max).

SECONDARY outcome

Timeframe: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP

Population: PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.

T(½) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore it was not possible to calculate T(½) for betamethasone dipropionate or betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

Outcome measures

Measure	LEO 80185 Gel n=32 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Pharmacokinetic Evaluation T(½) Betamethasone dipropionate	NA h Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, therefore it was not possible to calculate T(½).
Pharmacokinetic Evaluation T(½) Betamethasone 17-propionate	NA h Betamethasone 17-propionate was only detected above lower limit of quantification in 12 samples from 5 subjects, therefore it was not possible to calculate T(½).

SECONDARY outcome

Timeframe: End of treatment

Population: Full analysis set

Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the investigator's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment Controlled	62 Participants
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment Non-controlled	45 Participants

SECONDARY outcome

Timeframe: From baseline to end of treatment

Population: Full analysis set

Percentage change in Psoriasis area and severity index (PASI) score from baseline to end of treatment, defined as the last value recorded up to and including Week 8. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Percentage Change in PASI From Baseline to End of Treatment	-78.7 Percentage change in PASI score Standard Deviation 32.4

SECONDARY outcome

Timeframe: End of treatment

Population: Full analysis set

Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the patient's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.

Outcome measures

Measure	LEO 80185 Gel n=107 Participants LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions.
Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment Non-controlled	40 Participants
Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment Controlled	67 Participants

Adverse Events

LEO 80185 Gel

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure

LEO 80185 Gel n=107 participants at risk LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.

Psychiatric disorders Suicide attempt

0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.

Other adverse events

Measure	LEO 80185 Gel n=107 participants at risk LEO 80185 gel, containing calcipotriol (50 mcg/g) and betamethasone (0.5 mg/g, as dipropionate), was applied once daily to scalp and body psoriasis lesions. This arm contains all 107 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 31 subjects in this arm performed additional hypothalamic-pituitary axis assessments and constitute the per protocol analysis set.
Infections and infestations Nasopharyngitis	5.6% 6/107 • Number of events 6 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Rhinitis	1.9% 2/107 • Number of events 2 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Folliculitis	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Hordeolum	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Impetigo	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Peritonsillar abscess	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Upper respiratory tract infection	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Infections and infestations Viral infection	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Investigations Blood parathyroid hormone increased	3.7% 4/107 • Number of events 5 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Investigations Blood cortisol decreased	1.9% 2/107 • Number of events 2 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Investigations Eosinophil count increased	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Nervous system disorders Headache	5.6% 6/107 • Number of events 8 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Nervous system disorders Balance disorder	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Nervous system disorders Dizziness	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Nervous system disorders Syncope	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 2/107 • Number of events 2 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 2/107 • Number of events 2 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Skin and subcutaneous tissue disorders Acne	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Skin and subcutaneous tissue disorders Erythema	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Skin and subcutaneous tissue disorders Pruritus	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Skin and subcutaneous tissue disorders Sunburn	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Gastrointestinal disorders Abdominal pain upper	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Gastrointestinal disorders Constipation	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Gastrointestinal disorders Diarrhoea	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Musculoskeletal and connective tissue disorders Back pain	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Musculoskeletal and connective tissue disorders Muscle spasms	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Musculoskeletal and connective tissue disorders Neck pain	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Reproductive system and breast disorders Dysmenorrhoea	2.8% 3/107 • Number of events 3 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Injury, poisoning and procedural complications Arthropod sting	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Injury, poisoning and procedural complications Concussion	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Psychiatric disorders Sleep disorder	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Cardiac disorders Cardiovascular disorder	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Endocrine disorders Hyperparathyroidism	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Metabolism and nutrition disorders Iron deficiency	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Surgical and medical procedures Wisdom teeth removal	0.93% 1/107 • Number of events 1 • During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.

Additional Information

Clinical Disclosure Specialist

LEO Pharma A/S

Phone: +45 44945888

Email: disclosure@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee LEO acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. 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