A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris

NCT02518048 | Completed Phase 2 Results

• 1 other identifier: LP0053-1227
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster

Conditions

Skin and Connective Tissue Diseases

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline

  The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT). The mean TCS at Baseline was 6.6 for both groups.

  Day 1 (Baseline) to Day 29

Secondary Outcomes (3)

• Change in TCS at Individual Visits

  Day 1 (Baseline) to Day 29

• Change in Score of Erythema, Scaling, and Infiltration at Individual Visits

  Day 1 (Baseline) to Day 29

• Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT

  Baseline to End of Treatment

Study Arms (2)

LEO 90100 Aerosol foam

ACTIVE COMPARATOR

Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)

Drug: LEO 90100 Aerosol foam

Betesil® 2.25 mg

ACTIVE COMPARATOR

Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone).(Betesil® )

Drug: Betesil® 2.25 mg

Interventions

LEO 90100 Aerosol foam DRUG

LEO 90100 Aerosol foam

Betesil® 2.25 mg DRUG

Betesil® 2.25 mg

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent has been obtained
• Subjects with a diagnosis of psoriasis vulgaris with preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. For subjects with three lesions, each lesion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). For subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites.
• Age 18 years or above
• Outpatients
• Female subjects must be of either
• non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
• child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.

You may not qualify if:

• Female subjects who are breast feeding
• Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
• Etanercept - within 4 weeks prior to randomisation and during the trial
• Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
• Ustekinumab - within 16 weeks prior to randomisation and during the trial
• Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
• Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial
• Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
• PUVA: 4 weeks
• UVB: 2 weeks
• Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
• Potent or very potent (WHO group III-IV) corticosteroids
• Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
• WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
• Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, 06000, France

Location

Related Publications (1)

• Queille-Roussel C, Rosen M, Clonier F, Norremark K, Lacour JP. Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis. Clin Drug Investig. 2017 Apr;37(4):355-361. doi: 10.1007/s40261-016-0489-5.

  PMID: 27995521 RESULT

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Skin and Connective Tissue Diseases; Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

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

ctr.disclosure@leo-pharma.com

+45 44945888

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 10, 2025
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)