| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02965456 | Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 820 | — | — | Nov 4, 2015 | Feb 23, 2017 | Dec 18, 2019 | 34 | United States |
| NCT02932306 | Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 820 | — | — | Nov 3, 2015 | Feb 22, 2017 | Jan 3, 2020 | 39 | United States |
| NCT02849860 | Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris | PHASE1 | COMPLETED | 20 | — | — | Feb 1, 2014 | Oct 1, 2016 | Dec 14, 2017 | 2 | United States |
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 ...