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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
Cabtreo · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE2 | Acne mRNA vaccine |
| Sagimet Biosciences Inc. Class A | SGMT | 2 | PHASE3 | Denifanstat, TVB-3567 |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 |
Cabtreo is a topical treatment being developed for acne. It is a small molecule therapy applied to the skin and is being studied in adults 18 years and older with acne. It is investigational and has not been approved for commercial use.
Cabtreo is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker BHC. The company is the sponsor of the clinical program evaluating the topical acne treatment.
Cabtreo is in Phase 1 development. Its only listed trial is classified as an early Phase 1 study, and the program has not yet advanced to later-stage testing. It is investigational and is not approved for any indication.
Cabtreo is being evaluated in a single clinical trial, NCT05582434, titled Experience With Topical Acne Treatment. The study is an early Phase 1, randomized, controlled trial that is active but not recruiting, with an enrollment of 72 participants in the United States.
The Cabtreo trial NCT05582434 enrolls adults 18 years of age and older of any sex who have acne. It does not accept healthy volunteers, and the study is being conducted in the United States. Enrollment is listed at 72 participants.