An Exploratory Psoriasis Plaque Test Study With Different Dose Combinations of Calcipotriol Plus Betamethasone Dipropionate in the Daivobet® Gel Vehicle in Psoriasis Vulgaris

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriol plus BDP gel in different doses (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Catherine Queille-Roussel, MD, Principal Investigator, Affiliation: Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), 06202 Nice Cedex 3, France

The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components.

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

Primary outcome: The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration)

Secondary outcome:

Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.

Absolute change in Total Clinical Score (TCS) at individual visits compared to baseline

The absolute change in total skin thickness and echopoor band thickness at end of treatment compared to baseline.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject must provide written information.

- Age 18 years or above.

- Males, or females subjects.

- Subjects with lesions of psoriasis vulgaris located on arms and/or legs and/or trunk.

- Subjects with, in the opinion of the investigator, stable psoriasis

- Subjects with psoriasis lesions(plaques)assessed by a Total Clinical Score 4 to 9

inclusive but each individual item ≥ 1.

- Subjects willing and able to follow all the study procedures and complete the whole

study.

- Subjects affiliated to a social security system.

- Female of childbearing potential with a negative urine pregnancy test

Exclusion Criteria:

- Female subjects who are pregnant, of childbearing potential and who wish to become

pregnant during the study, or who are breast feeding.

- Systemic treatment with biological therapies within 4 weeks (etanercept), 2 months

(adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 halflives (whichever is longer) for experimental biological products prior to randomisation and during the study.

- Systemic treatments with all other therapies than biologicals, (e. g.,

corticosteroids, retinoids, immunosuppressants) within the 4 week period prior to randomisation and during the study.

- Subjects using one of the following topical drugs for the treatment of psoriasis

prior to randomisation and during the study: Potent or very potent (WHO group III-IV) corticosteroids (4 weeks).

- Subjects using of phototherapy prior to randomisation and during the study:

- PUVA (4 weeks)

- UVB (2 weeks).

- Subjects using one of the following topical drugs for the treatment of psoriasis

within two weeks prior to randomisation and during the study:

- WHO group I-II corticosteroids (except if used fortreatment of scalp and/or facial

psoriasis),

- Topical retinoids, Vitamin D analogues, Topical immunomodulators (e. g. macrolides),

Anthracen derivatives, Tar, Salicylic acid

- Subjects using emollients on the selected plaques within one week before

randomisation and during the study.

- 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 randomization and during the study.

- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular

psoriasis.

- Subjects with known/suspected disorders of calcium metabolism associated with

hypercalcemia within the last 10 years, based on medical history and/or subject interview.

- History of any severe disease or serious current condition 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

- Subjects who have accepted biopsies with a positive Hepatitis B, Hepatitis C or HIV

test

- Subjects who have received treatment with any non marketed drug substance within the

4 week period prior to randomisation or longer, if the class of the substancerequires a longer washout as defined above

- Subjects with current participation in any other interventional clinical

- Subjects with known or suspected hypersensitivity to component(s) of the

investigational products.

- Subjects with any concomitant medical or dermatological disorder(s) which might

preclude accurate evaluation of the psoriasis on the test areas.

- Subjects foreseeing an intensive solar exposure during the study or having been

exposed within two weeks preceding the screening visit.

- Subjects who have accepted the biopsies with any contraindication to skin biopsy

procedures.

- Subjects impossible to contact in case of emergency.

- In the opinion of the investigator, subjects are unlikely to comply with the Clinical

Study Protocol.

- Subjects who are in an exclusion period in the National Biomedical Research Register

of the French Ministry of Health at randomization.

- Subject under guardianship, hospitalized in a public or private institution, for a

reason other than the research or subject deprived of freedom.

- Subjects previously randomised in this trial.

Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD), Nice, Nice Cedex 3 06202, France

Starting date: April 2013
Last updated: July 22, 2013