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A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema

NCT06453512 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-03-18

No results posted yet for this study

Summary

A 4 week, open label, multi-centre (GP setting), post market clinical follow-up study with Doublebase Once in patients of any age and any severity of atopic eczema.

The study will involve patients who are already using emollients as part of their treatment regime, switching to Doublebase Once. Patients will ideally apply the product once daily for 4 weeks and SCORAD assessments will be performed, and patient questionnaires will be completed. A subgroup of adult patients (up to 15 patients) will also undergo skin hydration measurements for the first 8 days to evaluate objective measurements of skin hydration in patients with atopic eczema.

Photographs of the same, representative area of eczema will also be taken for all patients at baseline and after 4 weeks of using Doublebase Once.

Conditions

  • Atopic Eczema

Interventions

DEVICE

Doublebase Once

Emollient

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • Sherwood Forest Hospitals NHS Foundation Trust

    collaborator OTHER

  • Dermal Laboratories Ltd

    lead INDUSTRY

Principal Investigators

  • Simon T Royal, BMedSci BM BS · Dermal Laboratories Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2025-05-30
Completion
2025-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453512 on ClinicalTrials.gov