A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: LEO90100 cutaneous spray, ointment; Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate; Drug: LEO 90100 cutaneous spray, ointment, vehicle; Drug: Daivobet® ointment

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nice, France, Cedex 3
    • Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects having signed and dated an informed consent
2. Age 18 years or above
3. Either sex
4. All skin types
5. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk.

Exclusion Criteria:

1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
2. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer)for experimental biological products prior to randomisation and during the study
3. Systemic treatments 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 study

4. Use of phototherapy within the following time periods prior to randomisation and during the study:

   • PUVA or Grenz ray therapy (4 weeks)
   • UVB (2 weeks)

5. Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:

   • Potent or very potent (WHO group III-IV) corticosteroids

6. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study:

   • 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)
   • Anthracen derivatives
   • Tar
   • Salicylic acid
7. Subjects using emollients on the target plaques within one week before randomisation and during the study
8. Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study
9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history
11. Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
12. Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
13. History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency)
14. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
15. Subjects with current participation in any other interventional clinical trial, based on interview of the subject
16. Subjects with known or suspected hypersensitivity to component(s) of the investigational products
17. Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
19. Subjects impossible to contact in case of emergency
20. Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
21. Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation
22. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom
23. Subjects previously randomised in this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 90100 cutaneous spray ointment; LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).	Drug: LEO90100 cutaneous spray, ointment; once daily application, 4 weeks
Active Comparator: LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone; Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)	Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate; once daily application, 4 weeks
Placebo Comparator: LEO 90100 Cutaneous Spray, Ointment, Vehicle; LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.	Drug: LEO 90100 cutaneous spray, ointment, vehicle; once daily application, 4 weeks
Active Comparator: Daivobet® Ointment; Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)	Drug: Daivobet® ointment; once daily application, 4 weeks; Other Names: Taclonex® ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline	TCS range from 0 (all signs absent) to 9 (all signs severe).	Day 1 (Baseline)/Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Sign Scores	Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) 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 (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement.	Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)
Changes in Total Clinical Score (TCS) by Visit	Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.	Baseline and Days 4, 8, 11, 15, 18, 22, 25
Change From Baseline in Echo-poor Band Thickness at End of Treatment	Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound	Baseline and Day 29
Changes in Total Skin Thickness	Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline	Baseline and Days 8, 15, 22, and 29.

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Catherine Queille-Roussel, MD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 06202 Nice Cedex 3, France

Publications and helpful links

General Publications

• Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015 Apr;35(4):239-45. doi: 10.1007/s40261-015-0269-7.
• Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Semin Cutan Med Surg. 2015;34 S1:PA-10.
• Hollesen Basse L, Olesen M, Lacour J, Queille-Roussel C. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. J Invest Dermatol. 2014;134:S33(abst 192).

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (Estimated): May 4, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
• Other Study ID Numbers: LEO 90100-01; 2011-000153-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO