Psoriasis vulgaris MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Enstilar
Product Name: Enstilar
Product Code: Enstilar
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: CALCIPOTRIOL
CAS Number: 112828-00-9
Concentration unit: µg/kg microgram(s)/
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be enrolled in the study if all of the following criteria are met at the screening (visit 1) and baseline (visit 2) visits: 1. Women or men with chronic stable plaque psoriasis aged 18 years or older at the time of consent. Consent must be obtained prior to any study-related procedures. The participants must furthermore be willing to participate and must be of a condition capable of giving informed consent. Type of participant and disease characteristics: 2. History of chronic stable plaque psoriasis. 3. Candidate for topical treatment, as judged by the investigator. 4. Candidate for NB-UVB treatment, as judged by the investigator. 5. Two target lesions of ~3 cm at its longest axis located on the body (except for the scalp, face, or intertriginous areas), scoring at least 1 for each of redness, thickness, and scaliness on the TPSS. 6. Women involved in any sexual intercourse that could lead to pregnancy must agree to use an effective contraceptive method from at least 4 weeks before baseline (visit 2). Effective contraceptive methods are: Systemic hormonal contraceptives (oral contraceptive, transdermal patches, vaginal rings, long-acting injectables, or implants), intrauterine devices, vasectomy, or barrier methods of contraception in conjunction with spermicide. This must be used until EOT. Hormonal contraceptives must be on a stable dose for at least 4 weeks before baseline (visit 2). a. Women of nonchildbearing potential are as follows: i. Women =60 years of age. ii. Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation) iii. Women >40 and =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 8. Female participant who is breastfeeding, pregnant, or who is planning pregnancy during the study period. 9. History of concomitant skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments and the acquisition of biopsies. 10. Other psoriasis subtype (erythrodermic, guttate, pustular, inverse, drug-induced). 11. History or presence of signs or symptom of progressive or uncontrollable infectious, endocrine, neurological, renal, hepatic, cardiac, hepatic, vascular, pulmonary, gastrointestinal, hematological rheumatological, psychiatric or metabolic disturbance and/or abnormal blood test or vital signs other paraclinical information, including disorders of calcium metabolism, that, in the opinion of the investigator, may expose the patient to elevated or unnecessary risk or interfere with the interpretation of results. 12. Known hypersensitivity to any ingredient in the IMP or to components of the container. 13. Infectious skin lesions on treated areas (e.g., herpes, varicella, fungal, bacterial, and parasitic skin infections, skin manifestations in relation to tuberculosis). 14. Treated skin must not be affected by perioral dermatitis, striae atrophicae, atrophic skin, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds. 15. History or presence of signs or symptoms of a light dermatosis (e.g., polymorphic light eruption, juvenile spring eruption, actinic folliculitis, actinic prurigo, solar urticaria, or chronic actinic/photosensitivity dermatitis. 16. Participant has had, or is planning, a major surgery within 8 weeks prior to baseline during the study. 17. Participant has a contraindication to skin biopsies. 18. Are taking medication known to cause phototoxic reactions (e.g., nonsteroidal anti-inflammatory drugs, tetracyclines, or thiazides). 19. Participant is currently receiving an investigational product or device or has received one within 4 weeks prior to baseline, that in the opinion of the investigator, might interfere with the results. 20. Participant has used biologic medication 12 weeks prior to baseline visit (Day 0), or 5 half-lives (whichever is longer). 21. Use of any systemic treatment for psoriasis (such as methotrexate, immunosuppressive drugs, corticosteroids, azathioprine, or cyclosporine) within 4 weeks prior to baseline. 22. Use of any topical medication to treat psoriasis (including salicylic acid, retinoid, calcineurin inhibitors, corticosteroids, vitamin D analogue, or tar) within 2 weeks prior to baseline. Use of moisturizers and emollients are not exclusion criteria. 23. Participant had psoralen and ultraviolet A (PUVA) treatment within 12 weeks prior to baseline. 24. Participant had any UVB phototherapy (including tanning beds) or excimer laser within 12 weeks prior to baseline. 25. Participant had excessive sun exposure within 2 weeks prior to baseline. This includes unwillingness to minimize natural and artificial sun exposure. Sunscreen products and protective apparel are recommended for circumstances when exposure cannot be avoided. Sunscreen must not be applied on the clinic visit days before the visit. 26. Participant has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics. 27. History of keloid formation or hypertrophic scarring in suture sites or scars. 28. Known inability or unavailability of a participant to complete required study visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Evaluate the efficacy of Enstilar® foam in combination with NB-UVB in changing the TRM-cells microenvironment in the skin.;Secondary Objective: 1. Evaluate the efficacy of Enstilar® foam in combination with NB-UVB in changing other immune cells using quantitative immunohistochemistry and gene expression analysis over the study duration. 2. Evaluate the efficacy of Enstilar® foam in combination with NB-UVB on clinical and subjective disease activity.;Primary end point(s): •Change in number of TRM-cells in the epidermis and dermis between baseline, over the study duration. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD69, CD103. •Change in type of TRM-cells in the epidermis and dermis between baseline, during the study duration assessed using analysis of microenvironment surround TRM-cells. The following markers in combination will be used to differentiate TRM-cells: CD3, CD4, CD8, CD69, CD103. ;Timepoint(s) of evaluation of this end point: Baseline, Week 8, Week 13, Week 18. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in CD11c+ Dendritic-cells over the study duration. • Change in CD163+ Macrophages over the study duration. • Change in Langerin+/CD207+ Langerhans-cells over the study duration. • Change in Myeloperoxidase+ Neutrophils over the study duration. • Change in FOXP3+ cells over the study duration. • Change in Proliferation as assessed using Ki67 over the study duration. • Change in CD49a+ cells over the study duration. • Change in epidermal thickness over the study duration. • Change in the whole skin transcriptome over the study duration. • Change over the study duration for standardized clinical parameters Psoriasis Area and Severity Index (PASI), the 5-point Investigator's Global Assessment (IGA), the Dermatology Life Quality Index (DLQI), the Target Plaque Severity Score (TPSS) and target plaque area (TPA).;Timepoint(s) of evaluation of this end point: Baseline, Week 8, Week 13, Week 18. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology, Thomas E
Aarhus University
Outcome results
None listed