| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03168334 | A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302) | PHASE3 | COMPLETED | 801 | — | — | Jul 11, 2017 | Jul 24, 2018 | Apr 1, 2021 | 45 | United States, Canada |
| NCT03168321 | A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301) | PHASE3 | COMPLETED | 813 | — | — | Jun 29, 2017 | Jun 7, 2018 | Apr 1, 2021 | 45 | United States, Canada |
| NCT02938494 | Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris | PHASE2 | COMPLETED | 210 | — | — | Nov 1, 2015 | Sep 1, 2016 | Sep 23, 2020 | 16 | United States |
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.
| 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...