Approval Probability
TA Base Rate
Adjusted LOA
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Label indication CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. CABTREO is a combination of clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older. ( 1 ) FDA label
Also known as IDP-126 Gel, CABTREO
IDP-126 · 6 trials · 2 indications
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.
Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached
| 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 |
| One single fixed-combination product | EXPERIMENTAL | Participants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily |
| Two products | EXPERIMENTAL | Participants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily |
| Three products | EXPERIMENTAL | Participants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily |
| 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 |
| clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel | DRUG | Single topical treatment to be applied daily to area affected once daily. |
| adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel | DRUG | Two topical treatments to be applied to area affected once daily. |
| Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel | DRUG | Three topical treatments to be applied to area affected once daily. |
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...
IDP-126 is an investigational small molecule topical gel being developed for the treatment of acne vulgaris. It is also known as IDP-126 Gel. The product is in Phase 3 clinical development and has been studied in randomized, double-blind, active-controlled trials in the United States, Canada, and Belgium.
IDP-126 is being developed for the treatment of acne vulgaris, a common dermatological condition. All of the clinical trials conducted for IDP-126 have enrolled participants with acne vulgaris, including adolescents as young as 9 years old. It is a topical gel formulation intended for dermatology use.
IDP-126 is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor of the clinical development program for IDP-126 Gel in acne vulgaris.
IDP-126 is in Phase 3 clinical development for acne vulgaris. It is an investigational product and has not been approved by the FDA. Five clinical trials have been completed, including Phase 1, Phase 2, and Phase 3 studies, with no trials currently active.
IDP-126 has been evaluated in five completed clinical trials. These include NCT04892706, a Phase 2 study comparing IDP-126 Gel to Epiduo Forte Gel and vehicle gel, and the Phase 3 studies NCT04214652 and NCT04214639. An earlier Phase 1 pharmacokinetic study was registered as NCT03653403.
Yes, IDP-126 Gel is the same product as IDP-126. IDP-126 Gel is the topical gel formulation being developed by Bausch Health Companies Inc. for acne vulgaris. Searches for either name refer to the same investigational Phase 3 dermatology asset.