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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347255
• Other study ID #: LEO 90100-01
• Secondary ID: 2011-000153-23
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2011
• Last updated: January 26, 2016
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2016
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO90100 cutaneous spray, ointment
once daily application, 4 weeks
• LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate
once daily application, 4 weeks
• LEO 90100 cutaneous spray, ointment, vehicle
once daily application, 4 weeks
• Daivobet® ointment
once daily application, 4 weeks

Locations

Country	Name	City	State
France	Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)	Nice

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

References & Publications (3)

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)

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

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No