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

NCT05454722 | Completed

• 1 other identifier: DENI-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

SCORAD; CDLQI; QoL

Outcome Measures

Primary Outcomes (2)

• SCORAD

  Change in SCORAD (SCORing Atopic Dermatitis, based on Area, Intensity and Subjective score. (Score of 0-103 with the higher the score the more severe the condition)) over 4 weeks.

  4 weeks

• QoL

  Change in CDLQI (Child Dermatology Quality of Life Index (a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is effected)) over 4 weeks

  4 Weeks

Study Arms (1)

Adex Gel

EXPERIMENTAL

Dry Skin Emollient with Nicotinamide

Device: ADEX Gel

Interventions

ADEX Gel DEVICE

Emollient Gel with added anti-inflammatory

Adex Gel

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female.
• Aged between 1 year and 15 years.
• Patients with atopic eczema (personal or combined personal and familial atopy), of moderate severity in accordance with the NICE categorisation
• SCORAD assessment score of between 25 to 50.
• Minimum score of 6 on the CDLQI (QoL).
• Patients or their parents/ legal guardians must be able to read and understand the patient information sheet and sign the consent form.
• Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s), or new atopic eczema sufferers, who have not been using oral or topical corticosteroids, Adex Gel or immunomodulators for the last month.
• Patients who are willing to use only Adex Gel for 4 weeks.
• Patients who are willing to continue to use their standard wash regime for the duration of the study. This will be documented at the initial visit.

You may not qualify if:

• Under 1 year of age or over 15 years and 11 months at screening.
• Are currently using or have used in the past month, any oral or topically applied corticosteroids, Adex Gel or immunomodulators for their atopic eczema.
• Have a known history of intolerance or skin sensitivity to any of the ingredients of Adex Gel (as identified on the patient information sheet and product labelling), or similar products.
• Have mild eczema.
• Have severe or potentially infected eczema.
• Participating in other ongoing studies or have participated in a study in the previous 30 days.
• Patients, or their parents/ legal guardians, who may have difficulties completing the quality-of-life questionnaire, which will be written in English only.
• Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
• Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their participation in the study.

Sponsors & Collaborators

• Dermal Laboratories Ltd: lead

Study Sites (2)

Cripps Health Centre

Nottingham, Nottinghamshire, United Kingdom

Location

Atherstone Surgery

Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

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 Design

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

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: November 16, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)