Approval Probability
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Adjusted LOA
ML Risk
GI148512 · 1 trial · 1 indication
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.
| Arm | Type | Description |
|---|---|---|
| GI148512 (Benzoyl Peroxide 3% Gel) | EXPERIMENTAL | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. Comparison of 2 arms (GI148512 vs vehicle) |
| vehicle gel | PLACEBO_COMPARATOR | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. |
| Name | Type | Description |
|---|---|---|
| GI148512 | DRUG | GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg |
| vehicle gel | DRUG | Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide) |
Inclusion Criteria: * Male or female subjects 12 to 45 years (inclusive) of age in good general health. * Subjects must have both on the face: A) A minimum of 17 but not more than 60 inflammatory lesions (papules / pustules), including nasal lesions. And B) A minimum of 20 but not more than 150 n...
GI148512 is an investigational small molecule being developed for the treatment of acne vulgaris. It is currently in Phase 3 clinical development. The drug has been studied in a completed clinical trial involving Japanese subjects with acne vulgaris.
GI148512 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The drug is currently in Phase 3 clinical development for the treatment of acne vulgaris.
GI148512 is in Phase 3 clinical development. It is an investigational drug for the treatment of acne vulgaris and is not yet approved by regulatory authorities. A Phase 3 clinical trial of the drug has been completed.
GI148512 has been studied in one completed Phase 3 clinical trial with the identifier NCT01400932. This trial, titled 'Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects,' enrolled 360 participants in Japan.
GI148512 is the drug being studied in the clinical trial identified as STF115288. The trial is titled 'Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects.' The drug itself is referred to as GI148512.