Additional data:
PHASE 2 STUDY
OF CABTREO
VS EPIDUO FORTE1

COPRIMARY ENDPOINT:
Absolute reduction in inflammatory lesions with CABTREO was -30 vs -28 with Epiduo Forte at Week 121

  • Percent reduction for inflammatory lesions with CABTREO was -77% vs -73% with EPIDUO FORTE at Week 12

COPRIMARY ENDPOINT:
Absolute reduction in noninflammatory lesions with CABTREO was -37 vs -34 with EPIDUO FORTE at Week 121

  • Percent reduction for noninflammatory lesions with CABTREO was -72% vs -67% with EPIDUO FORTE at Week 12

The safety and efficacy of once-daily CABTREO were assessed in a Phase 2 double-blind, multicenter, randomized clinical trial

*Treatment success was defined as ≥2-grade reduction from baseline in EGSS and a score of 0 (clear) or 1 (almost clear) through Week 12.1,2

†Vehicle comprised of 2 treatment groups, one with vehicle stored at 2-8 °C and one with the vehicle stored at room temperature; results were analyzed for combined vehicle.1

EGSS, Evaluator’s Global Severity Score.

  • The safety and efficacy of once-daily CABTREO were assessed in a Phase 2 double-blind, multicenter, randomized, 12-week study of 686 subjects aged 12 years and older with moderate to severe acne vulgaris1
  • Subjects were randomized in a 2:2:1:1 ratio into four treatment groups: 220 subjects received once-daily CABTREO (stored at 2-8 °C), 220 subjects received Epiduo Forte (stored at room temperature), 110 subjects received vehicle (stored at 2-8 °C, vehicle group 1), and 110 subjects received vehicle (stored at room temperature, vehicle group 2)1
  • 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, nodules), and 35 to 150 non-inflammatory lesions (open and closed comedones)1
  • The coprimary efficacy endpoints of success on the EGSS, absolute change in inflammatory lesion count, and absolute change in non-inflammatory lesion count were assessed at Week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed1

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TREATMENT-EMERGENT ADVERSE REACTIONS FROM PHASE 2 TRIALicon

TREATMENT-EMERGENT ADVERSE REACTIONS FROM PHASE 2 TRIALicon

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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. Ortho Dermatologics. Data on file. 2. CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1% [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC.