Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2% urea/20% glycerol · 1 trial · 1 indication
The change in TEWL from treated and untreated skin before and after induction of skin irritation with SLS. SLS increases TEWL. An effective treatment protects skin from irritation and less TEWL increase is anticipated compared to untreated skin
Skin redness measurement by Objective Erythema (2D Skin Imaging) on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Captured 2D images are analysed to determine the skin erythema index (degree of redness, arbitrary numerical value), where a higher value denotes a stronger reaction/more redness. An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31
Objective skin redness measurement by Mexameter on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Skin redness is measured using a C\&K Mexameter probe to quantify SLS-induced skin irritation (arbitrary numerical scale). An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31
Skin redness by visual scoring on treated and untreated skin before induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.
Skin redness by visual scoring on treated and untreated skin after induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.
| Arm | Type | Description |
|---|---|---|
| Test cream (2% urea/20% glycerol) | EXPERIMENTAL | Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days |
| Reference cream 1: Miniderm® 20% cream (20% glycerol) | ACTIVE_COMPARATOR | Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days |
| Reference cream 2: Diprobase® cream (cream without humectants) | ACTIVE_COMPARATOR | Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days |
| Untreated | NO_INTERVENTION | Untreated skin area on the volar forearm |
| Name | Type | Description |
|---|---|---|
| 2% urea/20% glycerol cream | DRUG | Moisturizing cream for topical application |
| Miniderm® 20% cream | DRUG | Moisturizing cream for topical application |
| Diprobase® cream | DRUG | Emollient cream for topical application |
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 ...
2% urea/20% glycerol is an investigational small molecule being studied for the treatment of atopic dermatitis, a form of eczema. It is a topical moisturizer designed to improve the skin barrier in patients with this condition. The drug is currently in Phase 2 clinical development.
2% urea/20% glycerol is a combination of urea and glycerol, both of which are humectants that help retain moisture in the skin. By hydrating the skin, it aims to improve the skin barrier function in patients with atopic dermatitis. The specific molecular target is not disclosed.
2% urea/20% glycerol is being developed by Perrigo Company plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker PRGO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating atopic dermatitis.
2% urea/20% glycerol is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested in clinical trials. The drug is not yet available for commercial use.
2% urea/20% glycerol has one completed Phase 2 clinical trial registered under NCT03901144, titled "A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier." This randomized, double-blind, active-controlled study enrolled 50 participants with atopic dermatitis in the United Kingdom.
2% urea/20% glycerol is a specific combination of urea and glycerol formulated as a moisturizer. It is not known to be the same as any other named drug. Its mechanism of action, based on hydration, differs from many prescription treatments for atopic dermatitis that target immune pathways.