A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes); Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes); Daivobet® gel applied for 24 hours (+/- 2 hours); Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)
Intervention description: Once daily application, 3 weeks; Once daily application, 3 weeks; Once daily application, 3 weeks; Once daily application, 3 weeks
Intervention MeSH terms: Calcitriol; Betamethasone
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied
      then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20
      minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24
      hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ
      Dumas and JR Scholtz.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Following verbal and written information about the trial, the subject has to provide
             signed and dated informed consent before any study related activities are carried out.

          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. The lesions must have a total size suitable for application of 4
             different products.

          6. Subjects with, in the opinion of the investigator, stable psoriasis based on Total
             Plaque Score evaluated at screening visit and at visit 2 (baseline).

          7. Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of
             scores of erythema, scaling and infiltration) of 4 to 9 inclusive, but each individual
             item ≥ 1.

          8. Subjects willing and able to follow all the study procedures and complete the whole
             study.

          9. Subjects affiliated to a social security system.

         10. Female subjects of childbearing potential using a reliable method of contraception for
             at least 1 month before the study start and during the course of the study (e.g., oral
             contraceptive pill, intrauterine device, contraceptive patches, implantable
             contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal
             (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or
             tubal section/ligation).

         11. Female with a negative urine pregnancy test (at screening visit).

        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, icthyosis, 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.