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Also known as IDP-121 Lotion
IDP-121 · 3 trials · 1 indication
Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Acne severity will be determined by the investigator/evaluator based on a 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-121 Lotion | EXPERIMENTAL | IDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| IDP-121 Vehicle Lotion | PLACEBO_COMPARATOR | IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| IDP 121 Lotion | DRUG | IDP-121 lotion will be applied as per the instructions provided by the investigational center staff. |
| IDP-121 Vehicle Lotion | DRUG | IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff. |
| IDP-121 Lotion | DRUG | IDP-121 lotion will be applied as per the instructions provided by the investigational center staff. |
Key Inclusion Criteria: * Male or female at least 9 years of age and older. * Written and verbal informed consent must be obtained. Participants 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 participant reaches age of ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE2 | Acne mRNA vaccine |
| Sagimet Biosciences Inc. Class A | SGMT | 2 | PHASE3 | Denifanstat, TVB-3567 |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 |
IDP-121 is an investigational small molecule being developed for the treatment of acne vulgaris. It is formulated as a lotion and studied in patients with acne, including adolescents as young as 9 years old. It has not been approved by the FDA and remains in clinical development.
IDP-121 is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker BHC. The company is the sponsor of the clinical program evaluating the drug in acne vulgaris.
IDP-121 is in Phase 3 development for acne vulgaris. Two Phase 3 trials have been completed, along with one Phase 1 pharmacokinetic study. The drug is investigational and has not been approved by the FDA.
IDP-121 has been studied in three completed trials: NCT02965456 and NCT02932306, both Phase 3 efficacy and safety studies in acne vulgaris, and NCT02849860, a Phase 1 absorption and pharmacokinetic study. All three were conducted in the United States.
Yes. IDP-121 Lotion, IDP 121 Lotion, and IDP 121 are alternative names for the same investigational drug, IDP-121. The lotion formulation is the form evaluated in the acne vulgaris clinical program.
Across the three completed trials, 1,660 patients were enrolled. The two Phase 3 studies each enrolled 820 patients, and the Phase 1 pharmacokinetic study enrolled 20 patients. All trials were randomized, double-blind, and placebo-controlled.