Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2025-02-24
2025-12-19
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Scalp psoriasis
Subjects with the diagnosis of moderate scalp psoriasis
Daxxin Psoriasis Shampoo
Daxxin Psoriasis Shampoo at least 3 times a week and at most once a day as per instructions for use
Interventions
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Daxxin Psoriasis Shampoo
Daxxin Psoriasis Shampoo at least 3 times a week and at most once a day as per instructions for use
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Daxxin AB
INDUSTRY
Responsible Party
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Locations
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CTC
Mölndal, , Sweden
Enheten för kliniska studier, University Hospital Region Örebro
Örebro, , Sweden
Countries
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References
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Crowley J. Scalp psoriasis: an overview of the disease and available therapies. J Drugs Dermatol. 2010 Aug;9(8):912-8.
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.
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.
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.
Other Identifiers
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DAX_001
Identifier Type: -
Identifier Source: org_study_id