Additional data:
See how quickly patients experienced
results with CABTREO

Reduction in inflammatory lesions

  • Two Phase 3 studies show a mean reduction in inflammatory lesions with CABTREO of 54% vs 40% with vehicle at Week 4.1
  • Lesion reductions were greater with CABTREO vs vehicle gel as early as Week 4.1
  • The safety and efficacy of CABTREO were evaluated in two multicenter, randomized, double-blind clinical trials.
MEAN PERCENT REDUCTION IN INFLAMMATORY LESIONS at week 121

  • The safety and efficacy of once-daily CABTREO were assessed in two multicenter, randomized, double-blind, vehicle-controlled, parallel group Phase 3 clinical trials of 363 subjects 10 years of age and older with facial acne vulgaris1,2
  • 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 nodules1,2
  • 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 121,2
  • While subjects aged 10 to less than 12 years were included in these trials, CABTREO is not approved for use in patients less than 12 years of age1

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Reduction in noninflammatory lesions

  • Two Phase 3 studies show a mean reduction in inflammatory lesions with CABTREO of 54% vs 40% with vehicle at Week 4.1
  • Lesion reductions were greater with CABTREO vs vehicle gel as early as Week 4.1
  • The safety and efficacy of CABTREO were evaluated in two multicenter, randomized, double-blind clinical trials.
MEAN PERCENT REDUCTION IN INFLAMMATORY LESIONS at week 121

Demonstrated safety from first 4 weeks

Transient increases from baseline to Week 2 in scaling, erythema, itching, burning, and stinging were observed for CABTREO with scores beginning to normalize by Week 4.3

Adverse reactions recorded at Week 4 with CABTREO were mostly mild

Cutaneous safety and tolerability assessments were graded on a 4-point scale (0=none; 1=mild; 2=moderate; 3=severe).

Investigator-assessed hyperpigmentation and hypopigmentation are not shown, as no trends in dyspigmentation were observed.

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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.