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 a topical moisturizing formulation being studied for atopic dermatitis, a form of eczema. It is designed for application to the skin to support the skin barrier in adults with this condition. It is an investigational product and is not an approved treatment.
2% urea/20% glycerol is being developed by Perrigo Company plc, which trades on the New York Stock Exchange under the ticker PRGO. Perrigo is the sponsor of the clinical program evaluating this topical formulation in atopic dermatitis.
2% urea/20% glycerol is in Phase 2 clinical development. The program includes one completed Phase 2 trial conducted in the United Kingdom. The formulation remains investigational and has not been approved by the FDA for any indication.
2% urea/20% glycerol has been evaluated in one completed Phase 2 trial, NCT03901144, titled A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier. The trial enrolled 50 adults in the United Kingdom, was randomized, double blind, and used an active control.