Daxxin Psoriasis Shampoo PMCF

April 21, 2026 updated by: Daxxin AB

A Prospective, Single-arm, Open-label, Post-market Clinical Follow-up Investigation to Verify Performance and Safety of Daxxin Psoriasis Shampoo When Used for Treatment of Moderate Scalp Psoriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Mölndal, Sweden, 431 53
        • CTC
      • Örebro, Sweden, 70362
        • Enheten för kliniska studier, University Hospital Region Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scalp psoriasis
Subjects with the diagnosis of moderate scalp psoriasis
Device: Daxxin Psoriasis Shampoo
Daxxin Psoriasis Shampoo at least 3 times a week and at most once a day as per instructions for use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSSI score reduction at day 42
Time Frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
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).
From Day 0 (enrollment) to Day 42 after enrollment of each subject

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSSI score reduction at Days 14 and 28
Time Frame: From Day 0 (enrollment) to Day 28 after enrollment of each subject
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).
From Day 0 (enrollment) to Day 28 after enrollment of each subject
DLQI
Time Frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
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)
From Day 0 (enrollment) to Day 42 after enrollment of each subject
Scratch mark grades
Time Frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
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)
From Day 0 (enrollment) to Day 42 after enrollment of each subject
Itching
Time Frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
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
From Day 0 (enrollment) to Day 42 after enrollment of each subject
Subject reported symptoms
Time Frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
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)
From Day 0 (enrollment) to Day 42 after enrollment of each subject
Subject satisfaction
Time Frame: Day 42 after enrollment of each subject
To evaluate subject satisfaction after using Daxxin Psoriasis Shampoo, measured with a Likert scale at Visit 4 (Day 42).
Day 42 after enrollment of each subject
Device usability
Time Frame: Day 42 after enrollment of each subject
To evaluate device usability as measured by a Likert scale at Visit 4 (Day 42).
Day 42 after enrollment of each subject
Patient Safety
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
Incidence of AEs, adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), and device deficiencies (DDs) throughout the clinical investigation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daxxin AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Actual)

December 19, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAX_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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