Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis

NCT07817394 | Not Yet Recruiting

• 1 other identifier: DLPF-04
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This PMCF study is to obtain patient feedback using online questionnaires. There will be no involvement from healthcare professionals (HCPs) or investigator sites. Up to 100 Patients are being recruited by My Health Focus through their website. The study is performed throughout the UK except Northern Ireland with no sites involved in this study. Patients apply directly to participate in the study and the testing and questionnaire responses are completed at home.

Conditions

Psoriasis

Keywords

PMCF Survey

Outcome Measures

Primary Outcomes (1)

• Emollient performance

  Patient reported questionnaire responses on skin condition and product use. Scoring of 0 - 10 to specific skin condition and product parameters (0=Strongly agree - 10 strongly disagree)

  4 weeks use

Other Outcomes (1)

• Adverse Device effects and Device deficiencies

  weeks 1 - 4

Study Arms (1)

Main Group

EXPERIMENTAL

Doublebase Once

Device: Doublebase Once

Interventions

Doublebase Once DEVICE

Once Daily Emollient

Main Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with psoriasis of any severity previously diagnosed by a Healthcare Professional (HCP).
• Patients normally managing their skin condition by regular and ongoing use of leave-on emollient(s).
• Patients willing to incorporate Doublebase Once into their normal skin condition management routine for approximately 1 month as their only emollient and instead of their usual emollient

You may not qualify if:

• Does not regularly use an emollient
• Known history of intolerance or skin sensitivity to any of the ingredients of Doublebase Once (as identified on the Patient Information Sheet and product labelling), or similar products used.
• Currently participating in a study involving an investigational medicinal product/medical device or having participated in the previous 30 days.
• Patients currently residing in Northern Ireland (this is due to the different approval process)
• Patients (or their parents/legal guardians, in the case of infants, very young children or adolescent adults) who may have difficulties completing the feedback questionnaires, which will be written in English only.
• Employees of My Health Focus or the Sponsor (Dermal or the Diomed group companies), or any immediate family member (partner, offspring, parents, siblings or sibling's offspring) of such employees

Sponsors & Collaborators

• Dermal Laboratories Ltd: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Model Details: Single arm, open label study

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 14, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Dec 2026