Clinical trial NCT01347255: A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris
Official title: A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline
timeFrame: Day 1 (Baseline)/Day 29
Secondary outcomes:
measure: Change in Clinical Sign Scores
timeFrame: Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)
measure: Changes in Total Clinical Score (TCS) by Visit
timeFrame: Baseline and Days 4, 8, 11, 15, 18, 22, 25
measure: Change From Baseline in Echo-poor Band Thickness at End of Treatment
timeFrame: Baseline and Day 29
measure: Changes in Total Skin Thickness
timeFrame: Baseline and Days 8, 15, 22, and 29.
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Study officials:
affiliation: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 06202 Nice Cedex 3, France
name: Catherine Queille-Roussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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).