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A Study to Evaluate Adex Gel in the Treatment of Atopic Eczema.

NCT05454722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-17

No results posted yet for this study

Summary

This is a prospective, open label, uncontrolled study which will be performed in multiple Primary Care (GP) centres, in approximately 60 children (aged 1 year to 15 years) who have moderate atopic eczema and who are not currently using oral or topical corticosteroids or immunomodulators and have not used them in the previous month.

Study patients will be asked to use Adex Gel three times daily, for 4 weeks instead of their usual emollient or as the first treatment for their condition, and without supplementary use of any oral or topical steroids or immunomodulators (unless this becomes unavoidable, see section 4.6.3). The Scoring Atopic Dermatitis (SCORAD) assessment will be performed by the investigator/ research nurse at baseline and then after 2 and 4 weeks of treatment. Patients or their parents/ guardians will be asked to complete the quality-of-life questionnaires (Children's Dermatology Life Quality Index (CDLQI) at baseline and after 4 weeks of treatment. Photographs, which will not include any identifiable features or details of the patient, of one eczema affected area will also be taken at baseline and again 4 weeks after treatment.

Conditions

  • Atopic Eczema

Interventions

DEVICE

ADEX Gel

Emollient Gel with added anti-inflammatory

Sponsors & Collaborators

  • Dermal Laboratories Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2024-03-28
Completion
2024-03-28

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 NCT05454722 on ClinicalTrials.gov