Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10037157 Term: Psoriasis of scalp System Organ Class: 100000004858
Conditions
Interventions
Product Name: TACRO-Skin
Product Code: TACRO-Skin
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Tacrolimus
Other descriptive name: TACROLIMUS MONOHYDRATE
Concentration unit: % (W/W) per
Sponsors
Bay Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be able to understand the scope, risks and nature of the clinical study and decide independently on their participation 2) Males and females aged 18 years or older at the time of informed consent 3) Caucasian 4) Women of childbearing age must use an established contraceptive method (e.g. contraceptive pill, depot injection, spiral, abstinence, vasectomy of the partner), exceptions: 12 months of natural amenorrhoea, postoperatively (6 weeks after bilateral ovariectomy with or without hysterectomy) 5) Women of childbearing age must demonstrate a negative pregnancy test (urine rapid test) 6) Mild to moderate psoriasis vulgaris (plaque psoriasis) with scalp involvement for at least 6 months 7) s-IGA of 2 (mild scalp involvement) to 4 (severe scalp involvement) and 20% or higher or 5x5 cm or larger of scalp surface area (or 0.5% of Body Surface Area) affected 8) Discontinuation of systemic therapy with etanercept at least 4 weeks before start of study treatment (Visit 2 - baseline) 9) Discontinuation of systemic therapy with adalimumab and infliximab at least 12 weeks before start of study treatment (Visit 2 - baseline) 10) Discontinuation of systemic therapy with ustekinumab, all other biologics (incl. but not limited to IL 17 antagonists and IL-23 antagonists), and tacrolimus at least 12 weeks before start of study treatment (Visit 2 - baseline) 11) At least 4 weeks before start of study treatment (Visit 2 - baseline) discontinuation with other systemic therapies that have an effect on psoriasis, such as corticosteroids, methotrexate, retinoids, ciclosporin, fumaric acid esters, sulfasalzine, hydroxycarbamide, azathioprine, apremilast and other immunosuppressant or immunomodulating drugs 12) Discontinuation of UV therapy at least 4 weeks before start of study treatment (Visit 2 - baseline) 13) Discontinuation of topical treatment such as steroids, Vitamin D, tar, salicylic acid, dimeticon, and urea of scalp psoriasis at least 2 weeks before start of study treatment (Visit 2 - baseline) 14) Discontinuation of other physical and alternative therapy procedures (e.g. brine bath) at least 4 weeks before the start of study treatment (Visit 2 - baseline) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 101 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will not be permitted to enter the study: 1) Participation in another clinical study at least 4 weeks before the inclusion date 2) Pregnancy, planned pregnancy, lactation period 3) Chronic inflammatory skin or systemic disease or a skin or systemic disease affecting the barrier function of the skin, with the exception of psoriasis 4) Taking psoriasigen medicines (beta-blocker, angiotensin-converting-enzyme (ACE) inhibitors, lithium, antimalarials). If beta-blockers and ACE inhibitors are taken for a longer period of time (at a stable dose at least 2 weeks before start of study treatment (Visit 2 - baseline)), the inclusion is at the discretion of the Investigator 5) Intensive sun exposure (holiday, solarium) at least 4 weeks before start of study treatment (Visit 2 - baseline) and during the study 6) Non-drug treatments that could interfere with the conduct of the study 7) Use of vasoactive over-the-counter (OTC) products that interfere with the inflammation process of the skin in the scalp area 8) Use of nutritional supplements that can affect inflammatory processes in the body 9) Use of calcineurin inhibitors during the study 10) Topical application of cosmetic or hair care products during the study (hair gel, hair spray, etc.) 11) Use of medical shampoos (e.g. tar shampoo) 12) Current or potential contraindications, incompatibility or hypersensitivity to any of the ingredients of the IMP 13) Known drug abuse 14) Risk of haematological contagion (Human Immunodeficiency Virus (HIV), chronic or active Hepatitis B or C) 15) Subjects in close affiliation with the study personnel (e.g. immediate family member or subordinate), subjects who are a member of the clinical study personnel, or an employee of the sponsor or a CRO involved in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to analyse the efficacy of a Tacrolimus-containing solution (TACRO-Skin) in subjects with mild to severe scalp psoriasis measured by scalp Investigator’s Global Assessment (s-IGA) after 8 weeks of treatment (TACRO-Skin vs. placebo).;Secondary Objective: • evaluate efficacy of a TACRO-Skin in subjects with mild to severe scalp psoriasis (TACRO Skin vs. placebo) through s-IGA, scalp Patient’s Global Assessment (s-PGA), scalp modified Psoriasis Area and Severity Index (S-mPASI), and Physician’s Global Assessment (PGA), Visual Analogue Scale (VAS scalp pruritus [itch]) • evaluate the effect on subject’s quality of life of TACRO-Skin treatment in subjects with mild to severe scalp psoriasis (TACRO-Skin vs. placebo) • evaluate the systemic bioavailability of tacrolimus • evaluate the safety of Tacrolimus ;Primary end point(s): Proportion of subjects achieving an improvement in s-IGA after 8 weeks of treatment (Visit 7) (TACRO-Skin vs. placebo) to scale 0 or 1;Timepoint(s) of evaluation of this end point: s-IGA at screening, week 0,1,2,4,6,8 and early termination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change from baseline in severity scores s-IGA, s-PGA, S-mPASI, PGA and VAS; scalp pruritus (itch) •Change from baseline in quality of life via Scalpdex and Dermatology Life Quality Index (DLQI) from Visit 2 (baseline) to Visit 7 (end of treatment) •Determination of the systemic bioavailability of Tacrolimus at Visits 2 and 7 in a subgroup of subjects •Frequency of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: -s-IGA at screening, week 0,1,2,4,6,8 and early termination -s-PGA, S-mPASI, PGA and VAS at week 0,1,2,4,6,8 and early termination -QoL Scalpdex and DLQI at week 0,1,2,4,6,8 and early termination -PK week 0 and week 8 -AE/SAE at all visits | — |
Countries
France, Germany
Contacts
Public ContactClinical trials information
Bay Pharma GbmH
Outcome results
None listed