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

NCT ID: NCT02518048

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-01-31

Brief Summary

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

Detailed Description

The products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except Sundays) for 4 weeks. The application sites for each product will be determined according to random assignment. Depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.

Conditions

Skin and Connective Tissue Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LEO 90100 Aerosol foam

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

Group Type: ACTIVE_COMPARATOR

LEO 90100 Aerosol foam

Intervention Type: DRUG

Betesil® 2.25 mg

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® )

Group Type: ACTIVE_COMPARATOR

Betesil® 2.25 mg

Intervention Type: DRUG

Interventions

LEO 90100 Aerosol foam

Intervention Type: DRUG

Betesil® 2.25 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
• Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
• Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 27995521 (View on PubMed)

Related Links

https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

LP0053-1227

Identifier Type: -

Identifier Source: org_study_id