ESTABLISHED SAFETY FROM CLINICAL TRIALS1,2

  • In two 12-week Phase 3 studies, CABTREO established a safety profile in pediatric, adolescent, and adult patients with moderate to severe acne1,2
  • Adverse reactions were mild (59%), moderate (36.4%), and severe (4.5%)1,2
  • Overall, 2.5% (6/242) of subjects discontinued CABTREO because of local skin reactions1,2
Not an actual patient.
Not an actual patient.

Adverse Reactions (AEs) Reported by >1% of Subjects with Facial Acne Vulgaris Treated with CABTREO (and More Frequently than Vehicle) in Trials 1 and 21

These adverse reactions were mild (59.0%), moderate (36.4%), and severe (4.5%).1

adverse adverse

  • 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

*Application site pain also includes application site stinging and burning.

†Application site erythema also includes erythema.

‡Application site dryness also includes xerosis.

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Facial Cutaneous Tolerability Assessment During 12 Week Treatment Period in Subjects with Acne Vulgaris Treated with CABTREO in Trials 1 and 21,2

Local tolerability evaluations were conducted at each study visit by assessment of erythema, scaling, itching, burning, and stinging. Local tolerability scores increased during the first two weeks of treatment and decreased thereafter. The table below presents the signs and symptoms of local facial tolerability during the 12 Week treatment period in subjects treated with CABTREO.1

MAXIMUM DURING TREATMENT§

facila-1 facila-1

WEEK 12 (END OF TREATMENT)§

facila-1 facila-1

§The denominators for calculating the percentages were the number of subjects with at least one post-baseline cutaneous tolerability assessment.

  • 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

§The denominators for calculating the percentages were the number of subjects with at least one post-baseline cutaneous tolerability assessment.

Additional data: Demonstrated tolerability of CABTREO from Phase 2 trial2,3

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Treatment-emergent adverse events (TEAEs) in patients who received CABTREO2,3

  • The most common TEAEs were application site pain and dryness2,3
  • The rate of discontinuation for CABTREO was 2.8%3

TREATMENT EMERGENT

SEVERITY OF TEAEs

RELATED TEAEs

TEAEs AT WEEK 12 DURING PHASE 2 STUDY2,3

facila-1 facila-1

#None of the SAEs were considered related to study drug.

||1 participant of the vehicle gel group discontinued the study drug, but not the study, due to a TEAE.

SEVERITY OF TEAEs

facila-1 facila-1

RELATED TEAEs REPORTED BY ≥2% OF PARTICIPANTS IN ANY TREATMENT GROUP7

facila-1 facila-1

  • 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
  • TREATMENT EMERGENT
  • SEVERITY OF TEAEs
  • RELATED TEAEs

TEAEs AT WEEK 12 DURING PHASE 2 STUDY2,3

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

#None of the SAEs were considered related to study drug.

||1 participant of the vehicle gel group discontinued the study drug, but not the study, due to a TEAE.

TEAEs AT WEEK 12 DURING PHASE 2 STUDY2,3

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

#None of the SAEs were considered related to study drug.

||1 participant of the vehicle gel group discontinued the study drug, but not the study, due to a TEAE.

TEAEs AT WEEK 12 DURING PHASE 2 STUDY2,3

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

#None of the SAEs were considered related to study drug.

||1 participant of the vehicle gel group discontinued the study drug, but not the study, due to a TEAE.

TEAEs AT WEEK 12 DURING PHASE 2 STUDY2,3

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

#None of the SAEs were considered related to study drug.

||1 participant of the vehicle gel group discontinued the study drug, but not the study, due to a TEAE.

SEVERITY OF TEAEs

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

SEVERITY OF TEAEs

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

SEVERITY OF TEAEs

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

SEVERITY OF TEAEs

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

RELATED TEAEs REPORTED BY ≥2% OF PARTICIPANTS IN ANY TREATMENT GROUP7

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

RELATED TEAEs REPORTED BY ≥2% OF PARTICIPANTS IN ANY TREATMENT GROUP7

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

RELATED TEAEs REPORTED BY ≥2% OF PARTICIPANTS IN ANY TREATMENT GROUP7

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 1.2%.

RELATED TEAEs REPORTED BY ≥2% OF PARTICIPANTS IN ANY TREATMENT GROUP7

ADAP, adapalene 0.15%; BPO, benzoyl peroxide 3.1%; CLIN, clindamycin phosphate 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.
3. 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. Am J Clin Dermatol. 2022;23(1):93-104.