Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03901144
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2019-04-01
Brief Title:
A NOVel Moisturiser for Atopic Dermatitis Effect on the Skin Barrier
Sponsor:
ACO Hud Nordic AB
Organization:
ACO Hud Nordic AB
Study Overview
Official Title:
A Phase 2 Randomised Controlled Trial of a NOVel Moisturiser for Atopic Dermatitis Effect on the Skin Barrier in Adults With a Predisposition to a Skin Barrier Defect
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 110757 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 110757 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 110757 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
The newly developed moisturizing cream 110757 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 110757 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 110757 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002945-12 | EUDRACT_NUMBER | None | None |