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

Phase 3

Completed

• Conditions: psoriasis vulgaris

• Registration Number: JPRN-jRCT2080224538
• Lead Sponsor: EO Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-31
• Study Completion: 2019-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 182

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified