Efficacy and safety of LEO 90100 foam in Japanese subjects with psoriasis vulgaris

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224538

Enrollment

180

Registered

2019-01-31

Start date

2019-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis vulgaris

Interventions

investigational material(s) Generic name etc : LEO 90100 foam INN of investigational material : combination of calcipotriol hydrate plus betamethasone dipropionate Therapeutic category code : 269 Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Japanese subjects aged 20 years or more 2.Clinical diagnosis of psoriasis vulgaris of less than or equal to 30% BSA (excluding any psoriasis on the face, skin folds, genitals) 3.A target psoriasis lesion on the body, of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of redness, thickness and scaliness 4.Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control

Exclusion criteria

Exclusion criteria: 1. Use of systemic treatment with an effect on psoriaisis 2. Use of UV therapy on full body or on the target lesion 3. Use of topical treatment on areas to be treated with trial medication 4. Topical treatment on areas other than treated areas with vitamin D analogues, immunosuppressants or strong/very strong corticosteroids 5. Skin diseases besides psoriasis on the areas to be treated with trial medication. 6. Disorders of calcium metabolism, hypercalcaemia, renal insufficiency, hepatic disorders, heart disease.

Design outcomes

Primary

Measure	Time frame
efficacy Primary Objective:To compare the efficacy of LEO 90100 foam with Dovobet ointment in the treatment of psoriasis in Japanese subjects. Primary Endpoint:The primary endpoint is "overall improvement rate" for the target lesion at Visit 4 (end of Week 4), defined as "substantial resolution" of clinical signs or at least "moderately improved" in the general change in the target 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.	—

Measure

Time frame

efficacy Primary Objective:To compare the efficacy of LEO 90100 foam with Dovobet ointment in the treatment of psoriasis in Japanese subjects. Primary Endpoint:The primary endpoint is "overall improvement rate" for the target lesion at Visit 4 (end of Week 4), defined as "substantial resolution" of clinical signs or at least "moderately improved" in the general change in the target 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.

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Secondary

Measure	Time frame
safety efficacy Secondary Objectives:To compare the safety of LEO 90100 foam with Dovobet ointment in the treatment of psoriasis in Japanese subjects. Secondary Endpoints:The "overall improvement rate" for the target lesion at Visits 2 and 3 (end of Weeks 1 and 2). The change in the total sign score from Visit 1 to Visit 4; total sign score is defined as the sum of the scores from the 3 clinical signs assessing severity in the target lesion. The change in the sum of the scores (total sign score) for the severity of the three clinical signs (thickness, scaliness, redness) from Visit 1 to the sum of the scores at Visit 4 (end of Week 4) for the target lesion. The number of adverse events.	—

Measure

Time frame

safety efficacy Secondary Objectives:To compare the safety of LEO 90100 foam with Dovobet ointment in the treatment of psoriasis in Japanese subjects. Secondary Endpoints:The "overall improvement rate" for the target lesion at Visits 2 and 3 (end of Weeks 1 and 2). The change in the total sign score from Visit 1 to Visit 4; total sign score is defined as the sum of the scores from the 3 clinical signs assessing severity in the target lesion. The change in the sum of the scores (total sign score) for the severity of the three clinical signs (thickness, scaliness, redness) from Visit 1 to the sum of the scores at Visit 4 (end of Week 4) for the target lesion. The number of adverse events.

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026