AzTrials
AzTrials

Scalp PsoriasisNCT06771648

Daxxin Psoriasis Shampoo PMCF

A study of Scalp Psoriasis, run by Daxxin AB at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scalp Psoriasis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
2 sitesSweden
Study dates
24 Feb 2025to 19 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • CTC

    Mölndal, 431 53

  • Enheten för kliniska studier, University Hospital Region Örebro

    Örebro, 70362

Other trials in Sweden

About this study

Official 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

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.

Read the 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.

Conditions
Scalp Psoriasis
Being tested
Daxxin Psoriasis Shampoo
Keywords
scalp psoriasis, shampoo, PMCF, Daxxin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daxxin Psoriasis ShampooDevice

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

Study groups in NCT06771648
Study groupRoleWhat they receive
Scalp psoriasisExperimentalSubjects with the diagnosis of moderate scalp psoriasis
Receives: Device: Daxxin Psoriasis Shampoo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From Day 0 (enrollment) to Day 42 after enrollment of each subject

Secondary outcomes (8)

  1. 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).

    Measured: From Day 0 (enrollment) to Day 28 after enrollment of each subject

  2. 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)

    Measured: From Day 0 (enrollment) to Day 42 after enrollment of each subject

  3. 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)

    Measured: From Day 0 (enrollment) to Day 42 after enrollment of each subject

  4. 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

    Measured: From Day 0 (enrollment) to Day 42 after enrollment of each subject

  5. 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)

    Measured: From Day 0 (enrollment) to Day 42 after enrollment of each subject

  6. Subject satisfaction

    To evaluate subject satisfaction after using Daxxin Psoriasis Shampoo, measured with a Likert scale at Visit 4 (Day 42).

    Measured: Day 42 after enrollment of each subject

  7. Device usability

    To evaluate device usability as measured by a Likert scale at Visit 4 (Day 42).

    Measured: Day 42 after enrollment of each subject

  8. Patient 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start24 Feb 2025
  3. Primary completion19 Dec 2025
  4. Study completion19 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771648
Sponsor's protocol ID
DAX_001
Status last verified
Dec 2025
First submitted
19 Dec 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Crowley J. Scalp psoriasis: an overview of the disease and available therapies. J Drugs Dermatol. 2010 Aug;9(8):912-8.

    PubMed 20684141

  • Mosca M, Hong J, Hadeler E, Brownstone N, Bhutani T, Liao W. Scalp Psoriasis: A Literature Review of Effective Therapies and Updated Recommendations for Practical Management. Dermatol Ther (Heidelb). 2021 Jun;11(3):769-797. doi: 10.1007/s13555-021-00521-z. Epub 2021 Apr 24.

    PubMed 33893995

  • Papadimitriou I, Bakirtzi K, Katoulis A, Ioannides D. Scalp Psoriasis and Biologic Agents: A Review. Skin Appendage Disord. 2021 Nov;7(6):439-448. doi: 10.1159/000517806. Epub 2021 Aug 3.

    PubMed 34901174

  • Blakely K, Gooderham M. Management of scalp psoriasis: current perspectives. Psoriasis (Auckl). 2016 Mar 29;6:33-40. doi: 10.2147/PTT.S85330. eCollection 2016.

    PubMed 29387592

Questions about this trial

What is this clinical trial studying?

A study of Scalp Psoriasis, run by Daxxin AB at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSSI score reduction at day 42 (time frame: From Day 0 (enrollment) to Day 42 after enrollment of each subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06771648, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in