LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Psoriasis

NCT02668692 | Completed Phase 3 Results

• 1 other identifier: LP0076-1128
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of LEO 80185 gel with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Conditions

Psoriasis Vulgaris

Keywords

LEO 80185 gel, calcipotriol, betamethasone

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With 'Overall Improvement' for the Target Lesion on the Scalp

  'Overall improvement' for the target lesion on the scalp, defined as 'substantial resolution' of clinical signs and/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 lesion.

  End of Week 4

Secondary Outcomes (2)

• Number of Subjects With 'Overall Improvement' for the Target Lesion on the Non-scalp Area of the Body

  End of Week 4

• The Change in the Sum of the Scores (Total Sign Score) for the Severity of the 3 Clinical Signs:Thickness, Scaliness, Redness From Baseline to End of Week 4 (Visit 1-4) for Each Target Lesion.

  From Baseline to end of Week 4 (Visit 1-4)

Study Arms (2)

LEO 80185 gel

EXPERIMENTAL

Drug: LEO 80185 gel

Dovobet ® ointment

ACTIVE COMPARATOR

Drug: Dovobet ® ointment

Interventions

LEO 80185 gel DRUG

calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions

LEO 80185 gel

Dovobet ® ointment DRUG

calcipotriol hydrate 52.2 µg/g \[equivalent to 50.0 µg/g calcipotriol\] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions

Dovobet ® ointment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Informed consent has been obtained.
• \. Japanese subjects
• \. Aged 20 years or above
• \. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA
• \. A target psoriasis lesion on the scalp and on the non-scalp area of the body, each lesion of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs (redness, thickness and scaliness).
• \. 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.
• \. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

You may not qualify if:

• \. Systemic use of biological treatments with a potential effect on psoriasis vulgaris
• \. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris
• \. PUVA therapy, UVB therapy or UVA therapy
• \. Topical treatment of psoriasis on the areas to be treated with trial medication
• \. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
• \. Topical treatment of conditions other than psoriasis with vitamin D analogues, potent or very potent corticosteroids or immunosuppressants
• \. Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris
• \. Patients with any of the following disorders (a) or symptoms (b) present on the areas to be treated with trial medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal, spirochetal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, ichthyosis, acne rosacea, ulcers, burns, frostbite, wounds, animal skin disease (scabies, crabs, lice, etc.) or (b) fragility of skin veins.
• \. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris.
• \. Erythrodermic, exfoliative or pustular psoriasis
• \. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight
• \. Known or suspected disorders of calcium metabolism associated with hypercalcaemia, or albumin-corrected serum calcium above the reference range
• \. Known or suspected severe renal insufficiency, severe hepatic disorders or severe heart disease.
• \. Known or suspected hypersensitivity to any components of the investigational products.
• \. Clinical signs or symptoms of Cushing's disease or Addison's disease

Sponsors & Collaborators

• LEO Pharma: lead
• CMIC Co, Ltd. Japan: collaborator

Study Sites (1)

Medical Corporation Bikyukai Kokubu Dermatology

Kitami-shi, Hokkaido, 090-0832, Japan

Location

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 10, 2025
• Results First Posted: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)