Trial Outcomes & Findings for Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris (NCT NCT03806790)

Last Updated: 2025-03-10

Results Overview

Overall improvement defined as 'Substantial Resolution' of Clinical Signs or at Least 'Moderately Improved' in the General Change in the Lesion. Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The details of the clinical scores are presented in secondary outcome measure description for 'Change in the total sign score'. Change in the Lesion is a 5 point scale below: * Markedly improved (best outcome) * Moderately improved * Slightly improved * Unchanged * Aggravated (worst outcome)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

182 participants

Primary outcome timeframe

End of Week 4

Results posted on

2025-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	LEO 90100 Foam calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Overall Study STARTED	87	95
Overall Study COMPLETED	87	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 90100 Foam n=87 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment n=95 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.	Total n=182 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 13.6 • n=5 Participants	54.8 years STANDARD_DEVIATION 12.9 • n=7 Participants	54.5 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	87 Participants n=5 Participants	95 Participants n=7 Participants	182 Participants n=5 Participants
Region of Enrollment Japan	87 participants n=5 Participants	95 participants n=7 Participants	182 participants n=5 Participants

PRIMARY outcome

Timeframe: End of Week 4

Population: The primary endpoint was analysed for the full analysis set. Rates of subjects with the event defined by the primary endpoint, 'overall improvement rate' for the target lesion at Visit 4 (end of Week 4), were compared between treatment groups by means of Fisher's exact test. Estimated rates, odds ratio, and its 95% CI were presented, together with the p-value from Fisher's exact test.

Outcome measures

Outcome measures
Measure	LEO 90100 Foam n=87 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment n=95 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Overall Improvement Rate for the Target Lesion	86 Participants	89 Participants

SECONDARY outcome

Timeframe: End of Weeks 1 and 2

Population: The secondary endpoints were analysed for the full analysis set. The number and percentage of subjects with 'overall improvement' were tabulated for Visits 2 and 3 (end of Weeks 1 and 2) and by treatment group.

Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion. Change in the Lesion is a 5 point scale below: * Markedly improved (best outcome) * Moderately improved * Slightly improved * Unchanged * Aggravated (worst outcome)

Outcome measures

Outcome measures
Measure	LEO 90100 Foam n=87 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment n=95 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Overall Improvement Rate for the Target Lesion at Weeks 1 and 2 Week 1	61 Participants	46 Participants
Overall Improvement Rate for the Target Lesion at Weeks 1 and 2 Week 2	83 Participants	77 Participants

SECONDARY outcome

Timeframe: End of Week 4

Population: The secondary endpoints were analysed for the full analysis set. For the change in the total sign score, the estimated difference between the treatment groups in the mean change (LEO 90100 foam group - Dovobet® ointment group) was calculated with 95% confidence interval. The treatment difference of the change in the total sign score at Visit 4 was estimated with an ANOVA with treatment as fixed effect.

The change in the total sign score from Week 0 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion. The severity for each of the 3 clinical signs was recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe. The sum of the 3 total sign scores could range from 0 (best) to 12 (worse). The greater the negative value for the change means a better outcome. Negative change denotes a decrease in the score and therefore a decrease in disease severity.

Outcome measures

Outcome measures
Measure	LEO 90100 Foam n=87 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment n=95 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Change in the Total Sign Score for the Target Lesion From Week 0 to Week 4	-7.09 score on a scale Standard Deviation 1.48	-5.98 score on a scale Standard Deviation 2.03

SECONDARY outcome

Timeframe: Treatment Emergent Adverse Events were assessed from Day 1 to end of Week 4, if Treatment Emergent Adverse Events were noted, they were followed for an additional 14 days

Population: The analysis of adverse events was based on the safety analysis set.

Number of treatment emergent adverse events (TEAEs). 14-day follow-up of TEAEs was only required if the TEAE was present at the last visit, and was of possible or probable relationship to trial medication.

Outcome measures

Outcome measures
Measure	LEO 90100 Foam n=87 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment n=95 Participants calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Number of Adverse Events	15 participants	19 participants

Adverse Events

LEO 90100 Foam

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Dovobet® Ointment

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical disclosure

LEO Pharma A/S

Phone: +4544945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all phase 3 clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
Publication restrictions are in place

Restriction type: OTHER

Measure	LEO 90100 Foam n=87 participants at risk calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g LEO 90100 foam: Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.	Dovobet® Ointment n=95 participants at risk calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g Dovobet® ointment: Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Musculoskeletal and connective tissue disorders Arthritis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Musculoskeletal and connective tissue disorders Tendonitis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Eye disorders Keratitis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
General disorders Pyrexia	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Infections and infestations Bronchitis	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Infections and infestations Folliculitis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Infections and infestations Furuncle	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Infections and infestations Gingivitis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Infections and infestations Nasopharyngitis	5.7% 5/87 • Number of events 5 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	5.3% 5/95 • Number of events 5 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Infections and infestations Pharyngitis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Injury, poisoning and procedural complications Animal bite	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Injury, poisoning and procedural complications Wound	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Investigations Blood calcium increased	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Investigations Glycosylated haemoglobin increased	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Skin and subcutaneous tissue disorders Acne	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	3.2% 3/95 • Number of events 3 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Skin and subcutaneous tissue disorders Dermatitis contact	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Skin and subcutaneous tissue disorders Pain of skin	1.1% 1/87 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	0.00% 0/95 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period
Vascular disorders Hypertension	0.00% 0/87 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period	1.1% 1/95 • Number of events 1 • Adverse event data were collected during 4 week treatment period and up to 2 weeks after the treatment period