Daxxin Psoriasis Shampoo PMCF

NCT06771648 | Completed

• 1 other identifier: DAX_001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Scalp Psoriasis

Keywords

scalp psoriasis; shampoo; PMCF; Daxxin

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (8)

• PSSI score reduction at Days 14 and 28

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

• DLQI

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

• Scratch mark grades

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

• Itching

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

• Subject reported symptoms

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

Study Arms (1)

Scalp psoriasis

EXPERIMENTAL

Subjects with the diagnosis of moderate scalp psoriasis

Device: Daxxin Psoriasis Shampoo

Interventions

Daxxin Psoriasis Shampoo DEVICE

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

Scalp psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daxxin AB: lead

Study Sites (2)

CTC

Mölndal, 431 53, Sweden

Location

Enheten för kliniska studier, University Hospital Region Örebro

Örebro, 70362, Sweden

Location

Related Publications (4)

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

  PMID: 20684141 BACKGROUND

• 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.

  PMID: 33893995 BACKGROUND

• 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.

  PMID: 34901174 BACKGROUND

• 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.

  PMID: 29387592 BACKGROUND

Related Links

• Daxxin Psoriasis Shampoo description

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 13, 2025
• Study Start: February 24, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: April 24, 2026

Record last verified: 2025-12

Locations

SE (2)