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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 being developed for the treatment of acne and acne vulgaris. It is formulated as a lotion and has been studied in clinical trials for these dermatological conditions.
IDP-123 is being developed by Bausch Health Companies Inc., which trades under the ticker symbol BHC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for acne.
IDP-123 is in Phase 1 of clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials, but it is still investigational and has not been approved by the FDA. The drug is being studied for the treatment of acne vulgaris.
IDP-123 has completed three clinical trials: NCT02849873, a Phase 1 study on absorption and pharmacokinetics; NCT02938494, a Phase 2 safety and efficacy study; and NCT03168321 and NCT03168334, both Phase 3 vehicle-controlled efficacy and safety studies. All trials are completed.
IDP-123 is not the same as Tazorac. In clinical trials, IDP-123 lotion was compared with Tazorac cream as an active control, but they are different products. IDP-123 is an investigational drug, while Tazorac is a reference treatment used in the studies.