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CABTREO CLEARANCE COULD BE AS CLOSE AS 12 WEEKS AWAY FOR YOUR PATIENTS1,2

Not an actual patient.
PHASE 3 PHASE 2 VS DYAD PRODUCTS PHASE 2 VS DYAD PRODUCTS

50% of patients had clear or almost clear skin at Week 12 in two Phase 3 clinical trials1,2

  • In study 1, 50% of patients receiving CABTREO (n=122) achieved treatment success* vs 25% of those receiving vehicle (n=61)1,2
    P<0.01
  • In study 2, 51% of patients receiving CABTREO (n=120) achieved treatment success* vs 21% of those receiving vehicle (n=60)1,2
    P<0.001

TREATMENT SUCCESS AS DEFINED BY EGSS THROUGH WEEK 12

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

EGSS, Evaluator’s Global Severity Score.

  • 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

Statistically significant reductions observed across both trials

Up to 80% mean percent reduction in inflammatory lesions at Week 121,2

PRIMARY ENDPOINT: Mean absolute reduction in inflammatory lesions with CABTREO Gel was -28 vs -22 with vehicle in study 1 and -30 vs -21 with vehicle in study 2 (P≤0.001 in both trials)1,2

Mean Percent Reduction in Inflammatory Lesions At Week 121,2

CABTREO, clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%; LS, least squares.

  • 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

Up to 73% mean percent reduction in noninflammatory lesions at Week 121,2

PRIMARY ENDPOINT: Mean absolute reduction in noninflammatory lesions with CABTREO Gel was -35 vs -24 with vehicle in study 1 and -35 vs -22 in study 2 (P≤0.001 in both trials)1,2

Mean Percent Reduction in Noninflammatory Lesions At Week 121,2
Chart Chart
Chart Chart

CABTREO, clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15%; LS, least squares.

  • 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
ADVERSE REACTIONS FROM PHASE 3 TRIALS

Additional data:
 See how CABTREO tested against dyad products in a Phase 2 trial

53% of patients receiving
CABTREO experienced treatment success2,3†

Coprimary efficacy endpoints assessed at week 12:

  • Treatment success
  • Absolute change in noninflammatory lesion count
  • Absolute change in inflammatory lesion count

  • 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 success defined as ≥2-grade reduction from baseline in EGSS and a score of 0 (clear)
or 1 (almost clear).

‡No statistical analyses were conducted between CABTREO
and vehicle at Week 2, 4, or 8.

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

Patients receiving CABTREO
experienced 76% inflammatory
lesion reductions2,3

PRIMARY ENDPOINT: Absolute reduction in inflammatory lesions with CABTREO was -30 vs -20 with vehicle at Week 122,3

  • 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

†No statistical analyses were conducted between CABTREO and vehicle at Week 2, 4, or 8.

Patients receiving CABTREO
experienced 71% noninflammatory
lesion reductions2,3

PRIMARY ENDPOINT: Absolute reduction in noninflammatory lesions with CABTREO was -36 vs -22 with vehicle at Week 122,3

  • 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

†No statistical analyses were conducted between CABTREO and vehicle at Week 2, 4, or 8.

Substraction

It’s time to move toCABTREO CLEARANCE

Additional data:
 See how CABTREO tested against dyad products in a Phase 2 trial

  • Phase 2 Treatment Success
  • INFLAMMATORY LESIONS
  • NONINFLAMMATORY LESIONS

53% of patients receiving CABTREO experienced treatment success*2,3

Coprimary efficacy endpoints assessed at week 12:

  • Treatment success
  • Absolute change in noninflammatory lesion count
  • Absolute change in inflammatory lesion count

Phase 2 Treatment Success
Week 2 Data‡

PHASE 2 TREATMENT SUCCESS
WEEK 4 DATA‡

PHASE 2 TREATMENT SUCCESS
WEEK 8 DATA‡

PHASE 2 TREATMENT SUCCESS
WEEK 12 DATA‡

  • 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 success defined as ≥2-grade reduction from baseline in EGSS and a score of 0 (clear) or 1 (almost clear).

‡No statistical analyses were conducted between CABTREO and vehicle at Week 2, 4, or 8.

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

Patients receiving CABTREO experienced 76% inflammatory lesion reductions2,3

PRIMARY ENDPOINT: Absolute reduction in inflammatory lesions with CABTREO was -30 vs -20 with vehicle at Week 122,3

INFLAMMATORY LESION REDUCTIONS
AT WEEK 122,3†

  • 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

†No statistical analyses were conducted between CABTREO and vehicle at Week 2, 4, or 8.

Patients receiving CABTREO experienced 71% inflammatory lesion reductions2,3

PRIMARY ENDPOINT: Absolute reduction in inflammatory lesions with CABTREO was -36 vs -22 with vehicle at Week 122,3

NONINFLAMMATORY LESION REDUCTIONS
AT WEEK 122,3†

  • 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

†No statistical analyses were conducted between CABTREO and vehicle at Week 2, 4, or 8.

Substraction

It’s time to move to CABTREO CLEARANCE

TREATMENT-EMERGENT ADVERSE REACTIONS FROM PHASE 2 TRIAL icon

TREATMENT-EMERGENT ADVERSE REACTIONS FROM PHASE 2 TRIAL icon

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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.