The goal of this clinical investigation is to verify the performance and safety of the CE-marked Daxxin Psoriasis Shampoo to treat scalp psoriasis. Forty-one subjects with moderate scalp psoriasis are planned to be recruited at one site in Sweden. Subjects will be asked to use the shampoo between 3 and 7 times a week, as per the instructions for use from the manufacturer, for a period of 6 weeks.
Investigational device: Daxxin Psoriasis Shampoo, Basic UDI-DI: 733116220030 Intended use: Daxxin Psoriasis Shampoo is designed to alleviate symptoms related to scalp psoriasis, such as itchiness, redness, flaking, and scratch marks Overall design: This is a prospective, single-arm, open-label, post-market clinical follow-up investigation designed to verify performance and safety of Daxxin Psoriasis Shampoo when used by subjects with scalp psoriasis in need of treatment. The outcome will be evaluated and incorporated in the product specific clinical evaluation report (CER) and serve as a base for continuous investigations. Following approval from the ethical committee (EC), 41 subjects with the diagnosis of moderate scalp psoriasis will be recruited at sites in Sweden. The subjects should only use Daxxin Psoriasis Shampoo and no other shampoo during the study period. The overall duration of the investigation is estimated to 8 months, including a 6-months recruitment period. Expected duration of each subject's participation is 6 weeks with 4 visits at site. The investigation will be considered complete when the last subject has completed the last visit. Description of Medical Procedure: Daxxin Psoriasis Shampoo should be used at least 3 times a week and at most once a day (7 times per week). Daxxin Psoriasis Shampoo should be used according to the instruction for use (IFU), and it is important to leave the shampoo in the hair and scalp for 2-5 minutes after massaging a generous foam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Daxxin Psoriasis Shampoo at least 3 times a week and at most once a day as per instructions for use
CTC
Mölndal, Sweden
Enheten för kliniska studier, University Hospital Region Örebro
Örebro, Sweden
PSSI score reduction at day 42
Percentage of subjects with reduction of at least 1-grade in the PSSI (Psoriasis Scalp Severity Index) score, at Visit 4 (Day 42) compared to Day 0 (baseline).
Time frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
PSSI score reduction at Days 14 and 28
Percentage of subjects with reduction of at least 1-grade in the PSSI score, at Visit 2 (Day 14) and Visit 3 (Day 28) compared to Day 0 (baseline).
Time frame: From Day 0 (enrollment) to Day 28 after enrollment of each subject
DLQI
Change in Quality of Life assessed with Dermatology Life Quality Index Scale (DLQI) from baseline (Day 0) to Visit 2 (Day 14), to Visit 3 (Day 28), Visit 4 (Day 42)
Time frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
Scratch mark grades
Change in scratch mark grades from baseline (Day 0) to Visit 2 (Day 14), to Visit 3 (Day 28), and to Visit 4 (Day 42)
Time frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
Itching
Change in subject reported itching, assessed with scalp-specific itch NRS, from baseline (Day 0) to end of treatment Visit 4 (Day 42) including weekly reports
Time frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
Subject reported symptoms
Change in subject reported symptoms (itching, redness, and flaking) using Likert scale from baseline (Day 0) to Visit 2 (Day 14), to Visit 3 (Day 28), and to Visit 4 (Day 42)
Time frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subject satisfaction
To evaluate subject satisfaction after using Daxxin Psoriasis Shampoo, measured with a Likert scale at Visit 4 (Day 42).
Time frame: Day 42 after enrollment of each subject
Device usability
To evaluate device usability as measured by a Likert scale at Visit 4 (Day 42).
Time frame: Day 42 after enrollment of each subject
Safety
Incidence of AEs, adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), and device deficiencies (DDs) throughout the clinical investigation
Time frame: From the enrollment of the first subject to the last visit of the last subject, which is planned to correspond to a 8-month period