A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier

NCT ID: NCT03901144

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2019-12-10

Brief Summary

Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease and it is characterised by exacerbations or relapses over years. The patients have a genetically impaired skin barrier that can be evaluated by measuring the transepidermal water loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients. Moisturisers are first line treatment for AD patients and moisturisers are the most prescribed products in dermatology. The use of moisturisers have been found to reduce the need for steroids.

The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms, such as dryness, itching, and flaking. As most people with dry skin of different origin have an impaired skin barrier function, it is important to investigate the possible influence on the skin barrier after long-term (several weeks') treatment. It is of utmost importance to evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice of moisturiser.

The primary objective of the trial is to determine whether applying the test cream 1107.57 for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) two reference creams in adults with a predisposition to a skin barrier defect. Secondary objectives are to determine whether there is a difference between 1107.57 and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability, cream consumption and safety.

Participants will treat their lower volar forearms for 28 days with three different creams (test cream and two reference creams) and leave one area untreated as a control. Each forearm will have two different treatment areas and treatment allocation will be randomized. One Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is measured on their forearms to evaluate the effect on skin barrier function and skin hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by measuring TEWL on their forearms. Study participants will attend visits at the start of randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will also grade and evaluate the tolerability of the different creams.

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis; skin barrier; moisturiser; emollient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test cream (2% urea/20% glycerol)

Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days

Group Type: EXPERIMENTAL

2% urea/20% glycerol cream

Intervention Type: DRUG

Moisturizing cream for topical application

Reference cream 1: Miniderm® 20% cream (20% glycerol)

Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days

Group Type: ACTIVE_COMPARATOR

Miniderm® 20% cream

Intervention Type: DRUG

Moisturizing cream for topical application

Reference cream 2: Diprobase® cream (cream without humectants)

Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days

Group Type: ACTIVE_COMPARATOR

Diprobase® cream

Intervention Type: DRUG

Emollient cream for topical application

Untreated

Untreated skin area on the volar forearm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

2% urea/20% glycerol cream

Moisturizing cream for topical application

Intervention Type: DRUG

Miniderm® 20% cream

Moisturizing cream for topical application

Intervention Type: DRUG

Diprobase® cream

Emollient cream for topical application

Intervention Type: DRUG

Other Intervention Names

Miniderm Duo 20 mg/g + 200 mg/g cream; Canomini 20 mg/g + 200 mg/g cream

Eligibility Criteria

Inclusion Criteria

The participants have to meet all of the following criteria to be eligible to enter the study:

• Willing and able to provide informed consent
• Male or female and aged 18 years or above
• Volunteers able to read and understand English
• A personal history of atopic dermatitis

Exclusion Criteria

Participants meeting any of the following criteria will not be permitted to enter the study:

• Eczema on the volar forearms requiring anti-inflammatory treatment
• Possible allergy to ingredients in the study medications.
• Any serious current medical condition which, in the opinion of the Investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the test medications
• Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy, as judged by the Investigator
• Use of any topical product, including cosmetic leave-on products on the volar forearms, within 1 week prior to, and throughout the study
• Female participant who, according to the participant, is pregnant or breast-feeding, or plans to become pregnant during the course of the study
• Any participant-related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse), as judged by the Investigator
• Enrolment in any interventional study or use of an investigational drug within 3 months prior to the screening visit
• Volunteers judged by the PI to be inappropriate for the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

ACO Hud Nordic AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Sheffield Medical School

Sheffield, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-002945-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Novum ACO-CT-2018-01

Identifier Type: -

Identifier Source: org_study_id