LEO 90105 Ointment in Japanese Subjects With Psoriasis

NCT01422434 | Completed Phase 3 Results

• 1 other identifier: MCB 0903
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris.

Conditions

Psoriasis

Keywords

A national; multi-centre; prospective; randomised; double-blind; active-controlled; 3-arm; parallel group; 4 week study

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)

  The primary response criterion was the percentage change in m-PASI from baseline to Week 4. The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula: Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8.

  Baseline to Week 4

Secondary Outcomes (3)

• Change From Baseline in Target Lesion Assessment

  Baseline to Week 4

• Physician's Global Assessment of Psoriasis

  Week 4

• Change in mPASI From Baseline to Week 1

  Baseline to Week 1

Study Arms (3)

LEO 90105 ointment

ACTIVE COMPARATOR

LEO 90105 ointment applied once daily for 4 weeks.

Drug: LEO 90105 = calcipotriol + betamethasone dipropionate

Dovonex® ointment

ACTIVE COMPARATOR

Applied twice daily for 4 weeks.

Drug: Dovonex® = calcipotriol

Rinderon® - DP ointment

ACTIVE COMPARATOR

Applied once daily for 4 weeks

Drug: Rinderon® - DP = betamethasone dipropionate

Interventions

LEO 90105 = calcipotriol + betamethasone dipropionate DRUG

Applied once daily for 4 weeks.

Also known as: LEO 90105 = Dovobet/Daivobet/Taclonex

LEO 90105 ointment

Dovonex® = calcipotriol DRUG

Applied twice daily for 4 weeks.

Dovonex® ointment

Rinderon® - DP = betamethasone dipropionate DRUG

Applied once daily for 4 weeks.

Rinderon® - DP ointment

Eligibility Criteria

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

You may qualify if:

• Subjects having understood and signed a written informed consent form prior to any study related procedures being carried out.
• Japanese subjects.
• years of age or above.
• Either sex.
• Clinical diagnosis of psoriasis vulgaris amenable to topical treatment, involving arms and/or trunk and/or legs.
• A minimum m-PASI (Modified Psoriasis Area and Severity Index) score for extent of 2 in at least one body region (i.e.
• psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs).
• Psoriasis vulgaris on the trunk/limbs (excluding psoriasis on the genitals/skin folds) of not more than 30% body surface area (BSA).
• A target lesion of a minimum of 5 cm at its longest axis and preferably not located on an elbow or knee, scoring at least 3 for each of redness, thickness and scaliness, and at least 10 in total by the physician's assessment of severity of the target lesion - A physician's global assessment of disease severity of psoriasis on trunk/limbs of mild, moderate, severe or very severe.
• Females of childbearing potential must have a negative result for a urine pregnancy test at Day 0 (Visit 1) and must agree to use an adequate method of birth control, as judged by the (sub)investigator, during the study. The contraceptive method should have started an adequate amount of time before the pregnancy test, which is dependent on the partic-ular method used and as judged by the (sub)investigator, and must continue for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alter-native medical cause) or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).

You may not qualify if:

• Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to randomisation:
• etanercept, adalimumab, infliximab - 3 months
• ustekinumab - 4 months
• other products - 3 months/5 half-lives (whichever is longer).
• Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immu-nosuppressants such as ciclosporin and methotrexate) within 4 weeks prior to randomi-sation (use of inhaled and nasal corticosteroids is allowed, use of systemic antihistamines is allowed).
• Psoralen plus ultraviolet light A (PUVA) therapy, ultraviolet light B (UVB) therapy or ultraviolet light A (UVA) therapy within 4 weeks prior to randomisation.
• Topical treatment of psoriasis on area(s) to be treated with study medication within 2 weeks prior to randomisation (use of emollients is allowed during this 2-week period, but not after randomisation).
• Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D ana-logues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent World Health Organisation (WHO) group III or IV corticosteroids within 2 weeks prior to randomisation.
• Topical treatment of scalp psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or very potent WHO group IV corticosteroids within 2 weeks prior to randomisation.
• Topical treatment of conditions other than psoriasis with vitamin D analogues (e.g. calcipotriol, tacalcitol, maxacalcitol), or potent or very potent WHO group III or IV cor-ticosteroids within 2 weeks prior to randomisation.
• Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs, lithium and Angiotensin Converting Enzyme (ACE) inhibitors) during the study.
• Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis.
• Patients with any of the following disorders (a) or symptoms (b) present on the area(s) to be treated with study medication: (a) viral (e.g., herpes or varicella) lesions of the skin, fungal 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, or (b) fragility of skin veins..
• Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the trunk/limbs.
• Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc) during the study.

Sponsors & Collaborators

• LEO Pharma: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Tokai University School of Medicine

Isehara, Kanagawa, 259-1193, Japan

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Psoriasis

Interventions

betamethasone-17,21-dipropionate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical trial disclosure manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

00 45 44 94 58 88

Study Officials

• Akira Ozawa, MD, Professor

  Tokai University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 24, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 12, 2025
• Results First Posted: March 11, 2014

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)