Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed as a topical gel for the treatment of acne vulgaris and acne. It is intended for patients as young as 9 years old. The drug is currently in clinical development and is not approved by the FDA.
IDP-120 is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating acne vulgaris.
IDP-120 has completed Phase 1, Phase 2, and Phase 3 clinical trials. However, it remains an investigational drug and has not received FDA approval. The most advanced trials completed were Phase 3 studies evaluating the gel's efficacy in treating acne vulgaris.
IDP-120 has been studied in four clinical trials. These include a Phase 1 pharmacokinetic study (NCT02850003), a Phase 2 efficacy and safety trial (NCT03003247), and two Phase 3 trials (NCT03664739 and NCT03664752) comparing IDP-120 gel to vehicle gel in patients with acne vulgaris.
IDP-120 is a small molecule formulated as a topical gel for acne treatment. Its specific molecular target has not been disclosed in available clinical trial information. The drug is applied directly to the skin to treat acne vulgaris and acne.
No alternative names for IDP-120 have been reported. The drug is consistently identified as IDP-120 across its clinical trials and development program by Bausch Health Companies Inc.