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Completed

NCT Number: NCT06771648

Daxxin Psoriasis Shampoo PMCF

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.

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Key information

Conditions

Scalp Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTC, Mölndal, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years old
  • Clinical diagnosis of moderate scalp psoriasis assessed by Psoriasis Scalp Severity Index (PSSI, moderate = 3-10)
  • At least a score of 1 grade for each symptom erythema, induration and desquamation
  • 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
  • Subject agrees to refrain from using other treatments for scalp psoriasis during the clinical investigation
  • Subject is willing and able to provide written informed consent

Exclusion criteria

  • Known allergy or sensitivity to any component of the device
  • Use of psoriasis shampoo 2 weeks prior to enrolment
  • Use of other psoriasis scalp treatment i.e., Betnovate that could affect the study result within 4 weeks prior to enrolment
  • Use of systemic and/or biological treatment for psoriasis
  • Subject has a history of psoriasis unresponsive to topical treatments
  • Subject is pregnant, lactating at time of enrolment, or is planning to become pregnant during the study
  • Subjects with any other condition that, as judged by the investigator, may make investigation procedures inappropriate
  • Subject with alcohol or drug abuse

Treatment and study plan

Daxxin Psoriasis Shampoo

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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).

  7. 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).

  8. 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

Sponsors and collaborators

Lead sponsor

Daxxin AB

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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