Approval Probability
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Also known as IDP-120 Gel
IDP-120 · 4 trials · 2 indications
For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.
Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).
| Arm | Type | Description |
|---|---|---|
| IDP-120 Gel | EXPERIMENTAL | IDP-120 Gel, once-daily application |
| IDP-120 vehicle gel | PLACEBO_COMPARATOR | IDP-120 vehicle gel, once daily application |
| IDP-120 Component A Gel | ACTIVE_COMPARATOR | IDP-120 Monad Gel of Component A |
| IDP-120 Component B Gel | ACTIVE_COMPARATOR | IDP-120 Monad Gel of Component B |
| Name | Type | Description |
|---|---|---|
| IDP-120 Gel | DRUG | IDP-120 Gel, once-daily application |
| IDP-120 Vehicle Gel | DRUG | IDP-120 Vehicle Gel, once-daily application |
| IDP 120 Component A Gel | DRUG | Monad of Component A |
| IDP 120 Component B Gel | DRUG | Monad of Component B |
| IDP 120 Vehicle Gel | DRUG | Vehicle |
Inclusion Criteria: 1. Male or female at least 9 years of age and older; 2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent du...
IDP-120 is an investigational small molecule gel being developed for the treatment of acne and acne vulgaris. It is administered as a topical gel and is in clinical development. Bausch Health Companies Inc. is the developer. The program includes Phase 1, Phase 2, and Phase 3 studies conducted in the United States and Canada.
IDP-120 is being studied for the treatment of acne and acne vulgaris. Clinical trials have enrolled participants with acne vulgaris, with study eligibility beginning at 9 years of age. The program has included Phase 1 pharmacokinetic work, a Phase 2 efficacy and safety study, and two Phase 3 studies comparing IDP-120 Gel with IDP-120 Vehicle Gel.
IDP-120 is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor of the clinical program evaluating IDP-120 Gel in acne vulgaris, including Phase 1, Phase 2, and Phase 3 studies conducted in the United States and Canada.
IDP-120 is in Phase 1 development according to its current development stage, and the program has also completed Phase 2 and Phase 3 studies. IDP-120 is investigational and has not been established as approved for any indication. Its trials include NCT03003247 in Phase 2 and NCT03664752 and NCT03664739 in Phase 3.
IDP-120 has been evaluated in completed trials including NCT02850003, a Phase 1 pharmacokinetic study of topically applied IDP-120 Gel with 20 participants; NCT03003247, a Phase 2 study with 364 participants; and NCT03664752 and NCT03664739, two Phase 3 studies with 585 and 608 participants. All enrolled participants with acne vulgaris in the United States and Canada.
Yes, IDP-120 Gel is the same asset as IDP-120. The gel formulation is the name used in the clinical trial titles, including the Phase 3 studies comparing IDP-120 Gel with IDP-120 Vehicle Gel and the Phase 1 study of topically applied IDP-120 Gel. Searches for either name refer to the same investigational acne program.