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Also known as IDP-123 Lotion
IDP-123 · 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.
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.
Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe)
| Arm | Type | Description |
|---|---|---|
| IDP-123 Lotion | EXPERIMENTAL | Tazarotene 0.045% Lotion |
| IDP-123 Vehicle Lotion | PLACEBO_COMPARATOR | Vehicle Lotion |
| Tazorac Cream | ACTIVE_COMPARATOR | Cream |
| Vehicle Lotion | ACTIVE_COMPARATOR | Lotion |
| Vehicle Cream | ACTIVE_COMPARATOR | Cream |
| Name | Type | Description |
|---|---|---|
| IDP-123 Lotion | DRUG | Tazarotene 0.045% Lotion |
| IDP-123 Vehicle Lotion | DRUG | Vehicle Lotion |
| Tazorac Cream | DRUG | Cream |
| Vehicle Lotion | DRUG | Lotion |
| Vehicle Cream | DRUG | Cream |
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-123 is an investigational small molecule dermatology drug being developed by Bausch Health Companies Inc. for the treatment of acne and acne vulgaris. It is formulated as a lotion and has been studied in clinical trials in the United States and Canada.
IDP-123 is being developed for the treatment of acne and acne vulgaris. Clinical trials have evaluated the lotion in patients with acne vulgaris, including adolescents and adults, to assess efficacy and safety compared with vehicle or an active comparator.
IDP-123 is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company has sponsored the clinical development program for the IDP-123 Lotion formulation in acne vulgaris.
IDP-123 is an investigational drug that has completed Phase 1, Phase 2, and Phase 3 clinical trials. It has not been approved by the FDA. All four listed trials are completed, and no active trials are currently recruiting.
IDP-123 has been studied in completed trials including NCT03168334 and NCT03168321, two Phase 3 vehicle-controlled studies in acne vulgaris, NCT02938494, a Phase 2 study comparing IDP-123 Lotion to Tazorac Cream, and NCT02849873, a Phase 1 pharmacokinetic study.
Yes, IDP-123 Lotion is an alternative name for IDP-123. Both refer to the same investigational lotion formulation developed by Bausch Health Companies Inc. for the treatment of acne vulgaris.