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

NCT06453512 | Recruiting

• 1 other identifier: DLPF-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in SCORAD after 4 weeks of treatment

  The SCORAD scoring is described in section 7.4.1. For each patient, a score will be obtained at baseline, after 4 weeks. The minimum score is 0 (best outcome) and the maximum score is 103 (worst outcome). The change score will be calculated by subtracting the baseline score from the score after 4 weeks. The actual scores after 4 weeks and the change from baseline will be summarised using summary statistics. In addition, the change from baseline will be presented with a 95% confidence interval (CI), and the following hypotheses will be tested at the two-sided 5% significance level using a paired t-test. The SCORAD score is from 0-103 and there is a minimum score of 15 at inclusion. A reduction in total score represents an improvement in the overall condition.

  4 weeks

Secondary Outcomes (4)

• Change from baseline in SCORAD after 1 week of treatment.

  1 week

• SCORAD individual items

  4 weeks

• Patient Questionnaire

  4 weeks

• Skin Hydration

  8 days

Other Outcomes (1)

• Correlation between SCORAD and corneometry

  8 days

Study Arms (1)

Main Study

OTHER

Main Study which also involves the subgroup

Device: Doublebase Once

Interventions

Doublebase Once DEVICE

Emollient

Main Study

Eligibility Criteria

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

You may qualify if:

• ii) Patients with atopic eczema (personal history or combined personal and familial atopy), of any severity in accordance with the NICE categorisation set out in the table below.
• iii) Baseline SCORAD assessment score of at least 15. iv) Patients or their parents/ legal guardians must be able to read and understand the patient information sheet and sign the Consent Form/Assent Form.
• v) Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s).
• vi) Patients who are not currently using systemic or topically applied antibiotics or Doublebase Once.
• vii) Patients who are willing to use Doublebase Once, once daily, as their only leave-on emollient, for 4 weeks.
• viii) Patients who are willing to continue to use their standard cleansing regime and/or Doublebase Once as a soap substitute for the duration of the study.
• i) Baseline corneometry measurement of ≤40 arbitrary units.

You may not qualify if:

• i) Are currently using or have used in the previous month, any systemic or topically applied antibiotics or Doublebase Once for their atopic eczema.
• ii) Have a 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.
• iii) Currently participating in any other ongoing research studies or have participated in a study in the previous 30 days.
• iv) Patients, or their parents/ legal guardians, who may have difficulties completing the questionnaire, which will be written in English only.
• v) Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
• vi) Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their ability to participate in the study.

Sponsors & Collaborators

• Dermal Laboratories Ltd: lead
• Nottingham University Hospitals NHS Trust: collaborator
• Sherwood Forest Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cripps Medical Centre

Nottingham, Nottinghamshire, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Simon T Royal, BMedSci BM BS

  Dermal Laboratories Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie A Hart

CONTACT

01462 458866; valerie.hart@dermal.co.uk

Jennine L Walker

CONTACT

01462458866; jennine.walker@dermal.co.uk

Study Design

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

Model Details: Post market Surveillance

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 11, 2024
• Study Start: October 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: October 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)