A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Psoriasis Vulgaris

Treatments

Drug: Calcipotriol plus LEO 27989 ointment

Drug: Calcipotriol ointment

Drug: Vehicle ointment

Drug: LEO 27989 ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01297166

2010-022663-35

PLQ-006

Details and patient eligibility

About

The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and calcipotriol plus LEO 27989 ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects having understood and signed an informed consent form
Age 18 years or above
Males, or females of non-child bearing potential
All skin types
Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk.

Exclusion criteria

Male who are not willing to use a local contraception (such as condom) for the entire duration of the study, and refrain from fathering a child within 3 months following the last study drug application
Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
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
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
Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
- Potent or very potent (WHO group III-IV) corticosteroids
- PUVA or Grenz ray therapy
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 for treatment of scalp and/or facial psoriasis)
- Topical retinoids
- Vitamin D analogues
- Topical immunomodulators (e.g. macrolides)
- Anthracen derivatives
- Tar
- Salicylic acid
- UVB therapy
Subjects using emollients on the target 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, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation 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 hypercalcaemia based on medical history
Subjects with a positive Hepatitis B, Hepatitis C or HIV test
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)
Subjects with current participation in any other interventional clinical, based on interview of the subject
Subjects with known or suspected hypersensitivity to component(s) of the investigational products
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).
Subjects with a positive Hepatitis B, Hepatitis C or HIV test
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 (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
Subjects with any contraindication to skin biopsy procedures: e.g., allergy to local anaesthetics, topical antiseptics (chlorhexidine), bleeding tendency, treatment with anticoagulant drugs, history of poor wound healing, and history of vasovagal hypotension or syncope.