Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04214652 | Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 180 | — | — | Jan 27, 2020 | Mar 18, 2021 | Feb 1, 2024 | 13 | United States, Canada |
| NCT04214639 | Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 183 | — | — | Jan 17, 2020 | Jan 18, 2021 | Feb 1, 2024 | 13 | United States, Canada |
| NCT04892706 | Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel | PHASE2 | COMPLETED | 686 | — | — | Jun 11, 2021 | Sep 28, 2022 | Oct 30, 2025 | 42 | United States, Belgium +1 |
| NCT03170388 | A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris | PHASE2 | COMPLETED | 741 | — | — | Oct 5, 2017 | Apr 23, 2019 | Nov 10, 2021 | 34 | United States, Canada |
| NCT03653403 | Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel | PHASE1 | COMPLETED | 61 | — | — | Aug 8, 2018 | Jun 19, 2019 | Oct 21, 2019 | 1 | United States |
Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
During the study, subjects will be assessed for the occurrence of new and ongoing AEs. Descriptions of AEs will include the dates of onset and resolution, maximum severity, seriousness, action taken regarding study drug, corrective treatment, outcome, and investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the subject from the study or requires medical intervention prohibited by the protocol.
| Arm | Type | Description |
|---|---|---|
| IDP-126 Gel | EXPERIMENTAL | - |
| IDP-126 Vehicle Gel | PLACEBO_COMPARATOR | - |
| Epiduo® Forte Gel | ACTIVE_COMPARATOR | Epiduo® Forte Gel (adapalene 0.3%/ 2.5% BPO) applied once daily for 12 weeks |
| IDP-126 Component A | ACTIVE_COMPARATOR | Component A |
| IDP-126 Component B | ACTIVE_COMPARATOR | Component B |
| IDP-126 Component C | ACTIVE_COMPARATOR | Component C |
| Control Gel | ACTIVE_COMPARATOR | Gel |
| Name | Type | Description |
|---|---|---|
| IDP-126 Gel | DRUG | IDP-126 Gel applied topically to the face once daily for 12 weeks. |
| IDP-126 Vehicle Gel | DRUG | IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks. |
| Epiduo® Forte Gel | DRUG | Gel applied to face once daily in the evening. |
| IDP-126 Component A | DRUG | Component A |
| IDP-126 Component B | DRUG | Component B |
| IDP-126 Component C | DRUG | Component C |
| Control Gel | DRUG | gel |
Inclusion Criteria: * Male or female at least 9 years of age and older. * 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 duri...