Daxxin Psoriasis Shampoo PMCF

Daxxin AB41 enrolled

Overview

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Scalp Psoriasis

Interventions

Daxxin Psoriasis ShampooDEVICE

Daxxin Psoriasis Shampoo at least 3 times a week and at most once a day as per instructions for use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female ≥18 years old 2. Clinical diagnosis of moderate scalp psoriasis assessed by Psoriasis Scalp Severity Index (PSSI, moderate = 3-10) 3. At least a score of 1 grade for each symptom erythema, induration and desquamation 4. Subject is willing and able to use Daxxin Psoriasis Shampoo as directed, comply with investigation instructions, and commit to all follow-up visits for the duration of the investigation, as judged by the Investigator 5. Subject agrees to refrain from using other treatments for scalp psoriasis during the clinical investigation 6. Subject is willing and able to provide written informed consent Exclusion Criteria: 1. Known allergy or sensitivity to any component of the device 2. Use of psoriasis shampoo 2 weeks prior to enrolment 3. Use of other psoriasis scalp treatment i.e., Betnovate that could affect the study result within 4 weeks prior to enrolment 4. Use of systemic and/or biological treatment for psoriasis 5. Subject has a history of psoriasis unresponsive to topical treatments 6. Subject is pregnant, lactating at time of enrolment, or is planning to become pregnant during the study 7. Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate 8. Subject with alcohol or drug abuse

Locations (2)

CTC

Mölndal, Sweden

Enheten för kliniska studier, University Hospital Region Örebro

Örebro, Sweden

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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