Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
betamethasone valerate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1:1 | EXPERIMENTAL | Part 1 - eczema treatment |
| 1:2 | ACTIVE_COMPARATOR | Part 1 - eczema treatment |
| 2:1 | EXPERIMENTAL | Part 2 - maintenance treatment |
| 2:2 | NO_INTERVENTION | Part 2 - maintenance treatment |
| Name | Type | Description |
|---|---|---|
| betamethasone valerate | DRUG | Topical application according to a fixed schedule for three weeks |
| urea | DRUG | Topical application twice daily for up to 6 months |
Inclusion Criteria: * Females and males between 18 and 65 years of age * Caucasian * AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, ...
Betamethasone valerate is a small molecule under development for atopic eczema, a form of dermatitis. Perrigo Company plc is developing it as a Phase 3 candidate. The clinical program has focused on skin tolerance in adults with atopic eczema, with a completed trial that also examined the preventative properties of a moisturiser.
Betamethasone valerate targets NR3C1, the glucocorticoid receptor. It acts as an agonist at this receptor. This target class is consistent with its development as a small molecule for atopic eczema.
Perrigo Company plc, which trades under the ticker PRGO, is the developer of betamethasone valerate. The company is advancing the candidate for atopic eczema.
Betamethasone valerate is in Phase 3 development for atopic eczema. It is an investigational product and has not been approved by the FDA for this indication. The Phase 3 program includes one completed trial.
Betamethasone valerate has been studied in one completed Phase 3 trial, NCT00576238, titled "Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser." The trial enrolled 55 adults in Sweden and was randomized, double-blind, and active-controlled.