Clinical study with TACRO-Skin solution in subjects with mild to severe scalp psoriasis to investigate efficacy and safety of the solutio

Phase 1

• Conditions: Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10037157Term: Psoriasis of scalpSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-000215-92-FR
• Lead Sponsor: Bay Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-05
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified