Additional data:
PHASE 2 STUDY
OF CABTREO
VS EPIDUO FORTE

Additional data: Demonstrated tolerability of CABTREO from Phase 2 head-to-head study1

Most adverse events (AEs) with CABTREO were mild to moderate

  • AEs were similar between CABTREO and Epiduo Forte1
  • One serious adverse event (road traffic incident) in the CABTREO group1
  • The majority of related AEs were application site reactions1
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Treatment-emergent adverse events (TEAEs)
in patients who received CABTREO

  • The most common TEAEs were application site pain and dryness1
Treatment-Emergent Related Adverse Events through Week 12

  • The safety and efficacy of once-daily CABTREO were assessed in a Phase 2 double-blind multicenter, randomized, 12-week study of 741 subjects ≥9 years of age and older with facial acne vulgaris3
  • Subjects were equally randomized to once-daily CABTREO, vehicle, or 1 of 3 component dyad gels: BPO 3.1%/adapalene 0.15%; clindamycin phosphate 1.2%/BPO 3.1%; or clindamycin phosphate 1.2%/adapalene 0.15%3
  • Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 30 to 100 inflammatory lesions (papules, pustules, and nodules), 35 to 150 noninflammatory lesions (open and closed comedones) and two or fewer nodules3
  • The coprimary efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed3

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Important Safety Information AND INDICATION

CONTRAINDICATIONS

CABTREO is contraindicated in patients with:

  • known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any components of the formulation, or lincomycin.
  • history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
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Important Safety Information AND INDICATION

CONTRAINDICATIONS

CABTREO is contraindicated in patients with:

  • known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any components of the formulation, or lincomycin.
  • history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported. If a serious hypersensitivity reaction occurs, discontinue CABTREO immediately and initiate appropriate therapy.

Colitis: Clindamycin can cause severe colitis, which may result in death. Discontinue CABTREO if diarrhea occurs.

Photosensitivity: CABTREO may increase sensitivity to ultraviolet light. Avoid or minimize exposure to sunlight and sunlamps. Wear sunscreen and protective clothing when sun exposure cannot be avoided.

Skin Irritation and Allergic Contact Dermatitis: Stinging/burning/pain, erythema, dryness, irritation, exfoliation, and dermatitis may occur with use of CABTREO and may necessitate discontinuation. Weather extremes, such as wind or cold, may be irritating to patients under treatment with CABTREO. Depending upon severity, patients can use a moisturizer, reduce frequency of application, or discontinue use. Avoid applying CABTREO to areas of broken, eczematous, or sunburned skin, and concomitant use with other potentially irritating topical products. Avoid use of “waxing” as a depilatory method on skin treated with CABTREO.

Use of CABTREO with concomitant topical acne therapy has not been evaluated.

ADVERSE REACTIONS

The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.

DRUG INTERACTIONS

Use CABTREO with caution in patients receiving neuromuscular blocking agents.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.

Please click here for full Prescribing Information.

References: 1. Stein Gold L, Baldwin H, Kircik LH, et al. Efficacy and safety of a fixed-dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: a randomized phase II study of the first triple-combination drug. Amer J Clin Dermatol. 2022;23(1):93-104. 2. Ortho Dermatologics. Data on file. 3. CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC.