TRIPLE-COMBINATION RESULTS ACROSS A DIVERSE RANGE OF ACNE PATIENTS1,2

Not an actual patient.

Before-and-after photos from clinical trials1,2

13-year-old Asian Female (Phase 3)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

13-year-old Black Female (Phase 2)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

14-year-old White Female (Phase 3)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

17-year-old White Female (Phase 2)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

14-year-old Asian Male (Phase 2)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

18-YEAR-OLD WHITE MALE (Phase 3)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

18-year-old Hispanic Male (Phase 3)

Before-and-after image of CABTREO patient
week 4
week 8
week 12

18-YEAR-OLD ASIAN MALE (Phase 3)

Before-and-after image of CABTREO patient
week 4
week 8
week 12
  • Female
  • Male
Before-and-after images of a CABTREO patient

13-YEAR-OLD FEMALE

Before-and-after images of a CABTREO patient

13-YEAR-OLD FEMALE

Before-and-after images of a CABTREO patient

14-YEAR-OLD FEMALE

Before-and-after images of a CABTREO patient

17-YEAR-OLD FEMALE

Before-and-after images of a CABTREO patient

14-YEAR-OLD MALE

Before-and-after images of a CABTREO patient

18-YEAR-OLD MALE

Before-and-after images of a CABTREO patient

18-YEAR-OLD MALE

Before-and-after images of a CABTREO patient

18-YEAR-OLD MALE

Individual results may vary.

  • 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

  • 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

gray wave
Not an actual patient.

Not an actual patient.

Could CABTREO make a difference in YOUR practice?

A closer look at the diverse patient demographics1,2

Across both Phase 3 trials, patients were1,2:

component component

*Black or African American and White were the top 2 identified races among the trial enrollees while Hispanic or Latino is a representation of ethnicity.1,2

†American Indian/Alaska Native, Native Hawaiian/Other Pacific Islander, and Multiple/Not Reported.2

Substraction Substraction

The safety and efficacy of CABTREO were assessed in two Phase 3 trials with 363 subjects.1,2

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