Clinical trial NCT06771648: Daxxin Psoriasis Shampoo PMCF
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scalp Psoriasis
Keywords: scalp psoriasis
shampoo
PMCF
Daxxin
Lead sponsor: Daxxin AB
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PSSI score reduction at day 42
timeFrame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
Secondary outcomes:
measure: PSSI score reduction at Days 14 and 28
timeFrame: From Day 0 (enrollment) to Day 28 after enrollment of each subject
measure: DLQI
timeFrame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
measure: Scratch mark grades
timeFrame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
measure: Itching
timeFrame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
measure: Subject reported symptoms
timeFrame: From Day 0 (enrollment) to Day 42 after enrollment of each subject
measure: Subject satisfaction
timeFrame: Day 42 after enrollment of each subject
measure: Device usability
timeFrame: Day 42 after enrollment of each subject
measure: Safety
timeFrame: 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
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Enheten för kliniska studier, University Hospital Region Örebro
Study officials:
References:
citation: Crowley J. Scalp psoriasis: an overview of the disease and available therapies. J Drugs Dermatol. 2010 Aug;9(8):912-8.
citation: 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.
citation: 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.
citation: 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.