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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
CTC
RECRUITING
Mölndal
Enheten för kliniska studier, University Hospital Region Örebro
RECRUITING
Örebro
Contact Information
Primary
Maria Wikström, Master of Science
maria.wikstrom@allderma.se
+46707164461
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2025-09
Participants
Target number of participants: 41
Treatments
Experimental: Scalp psoriasis
Subjects with the diagnosis of moderate scalp psoriasis
Related Therapeutic Areas
Sponsors
Leads: Daxxin AB

This content was sourced from clinicaltrials.gov