Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acyclovir buccal/ BAYM008894/UI1614773 · 1 trial · 1 indication
Duration of episode (DOE) is defined as the time from the initiation of treatment (study intervention) to the healing of primary lesions (loss of crust) for participants who experience a vesicular lesion. For participants whose primary lesions are not vesicular in nature, duration of episode is the time from study intervention initiation to the return to normal skin as determined by the independent blinded reader of the participant's face images using a 6-point Likert scale or to the cessation of symptoms, whichever comes last.
| Arm | Type | Description |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet treatment group | EXPERIMENTAL | - |
| Matching placebo group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 | DRUG | Oral (upper gum area), 50mg, 1 tablet. |
| Placebo | DRUG | Oral (upper gum area), 1 table. |
Inclusion Criteria: * Males or females, 18 years of age or older inclusive; * History of recurrent HL lesions where: * Recurrence is defined as at least 4 episodes in the preceding 12 months; * At least half of the episodes should be vesicular in nature; * At least half of the episodes shoul...