Cabtreo (benzoyl peroxide/clindamycin/adapalene) / Bausch Health - LARVOL DELTA

A Novel Fixed Dose Triple Combination Therapy (IDP-126) for Moderate to Severe Acne. (PubMed, Skin Therapy Lett) - "Clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% (IDP-126) is a novel fixed-dose triad gel combination approved by the US FDA October 2023 and by Health Canada August 2024 for the treatment of acne vulgaris in patients aged 12 years and older...Efficacy outcomes were inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score. IDP-126 also had a favorable tolerability and safety profile."

Journal • Acne Vulgaris • Dermatology

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity. (PubMed, Dermatol Ther (Heidelb)) - P2, P3 | "CAB demonstrated superior efficacy to three dyads and branded ADAP 0.3%/BPO 2.5% in moderate acne participants, and generally numerically greater efficacy in severe acne participants. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head study."

Journal • Retrospective data • Acne Vulgaris

Bausch Health, Canada Inc. and the pan-Canadian Pharmaceutical Alliance Sign Letter of Intent for Public Drug Plan Coverage of (Pr)CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide gel) Treatment for Acne Vulgaris (ACCESSWIRE) - "Bausch Health, Canada Inc., part of Bausch Health Companies Inc...announced that it has signed a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) for Canadian public drug plan coverage for ^PrCABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. The letter of intent means Bausch Health, Canada Inc. can now proceed to finalizing individual listing agreements for CABTREO to be covered by each of Canada's government drug plans, including those of all provinces and territories and the federal government (including plans for veterans and Indigenous peoples)."

Reimbursement • Acne Vulgaris

Assessing the Adherence and Clinical Outcomes of using Multiple Topical Acne Products vs a Single Combination Product (AAD 2025) - "They were randomized into 3 treatment arms: one receiving adapalene+benzoyl peroxide+clindamycin (one topical), one arm receiving adapalene + benzoyl peroxide and clindamycin gel (two topicals), and one arm receiving adapalene gel, benzoyl peroxide gel, and clindamycin gel (three topicals). Poor adherence to topical treatment is common in patients with acne. Simplifying the treatment regimen to a single product may improve adherence."

Adherence • Clinical • Clinical data • Acne Vulgaris • Dermatology

Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne. (PubMed, J Clin Aesthet Dermatol) - "This pilot evaluation, albeit small and open-label, demonstrates promising results for the first studied combination of topical agents to target all four aspects of acne pathophysiology. Further large-scale studies are needed to further elucidate the additive efficacy and side effect profile when these two topical medications are used concomitantly."

Journal • Acne Vulgaris • Dermatology • Inflammation

Triple Therapy IDP-126 Gel for Acne Treatment: A Systematic Review and Meta-Analysis. (PubMed, Cureus) - "The recent FDA approval of IDP-126 (Cabtreo™), a novel triple-combination gel, meets these needs by combining clindamycin phosphate, benzoyl peroxide, and adapalene into a single formulation. IDP-126 is an effective treatment for AV, offering substantial clinical benefits and improving quality of life. While it is associated with higher rates of certain adverse effects, its overall efficacy supports its inclusion in treatment regimens, provided that its safety profile is carefully managed to optimize patient outcomes."

Journal • Retrospective data • Review • Acne Vulgaris • Dermatology • Pain

Efficacy and safety of the novel clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15%. triple combination in treating acne: systematic review and meta-analysis. (PubMed, Arch Dermatol Res) - No abstract available

Journal • Retrospective data • Review • Acne Vulgaris

A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel for the Treatment of Acne Vulgaris. (clinicaltrials.gov) - P1 | N=382 | Completed | Sponsor: Taro Pharmaceuticals USA

New P1 trial • Acne Vulgaris • Dermatology

CABTREOTM (Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide) Topical Gel. (PubMed, Skinmed) - "In both trials, subjects were randomized into two groups, one received IDP-126 gel and the other received vehicle gel. In Trial 2 (N = 180), treatment success was achieved in 50.5% (61/120) of subjects in the IDP-126 group versus 20.5% (12/60) of subjects in the vehicle group (P < 0.01). IDP-126 is therefore recommended to be applied as a thin layer to the affected area once daily."

Clinical • Journal • Acne Vulgaris • Dermatology

Application Characteristics and Patient Preference of Triple-Combination vs Layered Topicals for Acne: Split-Face Study. (PubMed, J Drugs Dermatol) - "Fixed-dose CAB gel was applied more evenly than separate application of its 3 active ingredients. By addressing 3 of the main acne pathogenic pathways in a single, easy-to-apply formulation, CAB gel may improve the efficacy of and adherence to acne treatment. J Drugs Dermatol. 2024;23(10):857-861. doi:10.36849/JDD.8430."

Clinical • Journal • Acne Vulgaris • Dermatology

Updates on Topical Dyad and Triple Combination Therapies Approved for Acne Vulgaris. (PubMed, Cureus) - "It was found that various topical dyad and triad combinations exist for acne vulgaris, including adapalene/BPO, tazarotene/clindamycin, clindamycin/BPO, adapalene/clindamycin, topical tretinoin/azelaic acid, topical tretinoin/BPO, and clindamycin phosphate/benzoyl peroxide/adapalene. Clindamycin phosphate/benzoyl peroxide/adapalene exhibited significantly high efficacy in treating both inflammatory and noninflammatory lesions, a minimal side effect profile, although no significant changes in quality-of-life measures. Further research is indicated to assess its long-term efficacy and impact on other acne metrics such as cost, scarring, psychosocial implications, and impact on diverse patient populations."

Combination therapy • Journal • Review • Acne Vulgaris • Dermatology

Cabtreo: A three-drug gel for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials (AAD 2024) - "Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients [1]. TEAEs were mostly of mild-moderate severity in all groups; rates were similar for IDP-126 and adapalene/BPO gels. Triple-combination IDP-126 gel demonstrated statistically significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and commercially available adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks."

Clinical • Acne Vulgaris

Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate-to-Severe Acne (AAD 2024) - "IDP-126 gel (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide [BPO] 3.1%)—the first fixed-dose triple-combination acne topical in development—demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability in phase 2 and phase 3 studies of moderate-to-severe acne [1-5]. The rate of TEAEs with IDP-126 treatment in Black participants was generally lower than in the overall study population (23.4% vs 24.6-36.2%) [1,3], and most TEAEs were of mild-to-moderate severity. Fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in Black participants with moderate-to-severe acne."

Clinical • Acne Vulgaris

Post-Hoc Exploratory Pooled Analysis of the Impact of IDP-126 Gel on QoL in Moderate-to-Severe Acne. (PubMed, J Drugs Dermatol) - "Across all Acne QoL domains, the improvement on the EGSS endpoint (53.8-63.3%) was more likely to influence QoL improvements than the inflammatory (20.1-33.4%) and non-inflammatory lesion (9.5-18.7%) counts.   This post hoc exploratory analysis of pooled phase 3 data (moderate to severe acne) suggests that treatment with IDP 126 Gel led to statistically significant and clinically meaningful improvements in QoL and improvement in QoL was primarily influenced by EGSS.J Drugs Dermatol. 2023;22(10):1033-1039      doi:10.36849/JDD.7812."

Journal • Retrospective data • Acne Vulgaris

Systematic Literature Review and Network Meta-Analysis to Assess the Comparative Efficacy of Topical Fixed-Dose Combinations for Moderate to Severe Acne Vulgaris as Measured By Lesion Counts (ISPOR-EU 2023) - "Based on the findings from this SLR/NMA, IDP-126 topical gel (currently under FDA review; PDUFA date 20 October 2023), was clinically superior to all other topical FDC treatments in reducing acne lesions in the patients with moderate to severe acne vulgaris."

Retrospective data • Review • Acne Vulgaris • Dermatology

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for moderate-to-severe acne: Efficacy and safety results from two randomized phase 3 trials. (PubMed, J Am Acad Dermatol) - "The innovative fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in 2 clinical studies of participants with moderate-to-severe acne."

Journal • P3 data • Acne Vulgaris

Dermal sensitization, safety, and tolerability of triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel from three clinical trials. (PubMed, J Dermatolog Treat) - P2 | "A total of 1,020 participants (IDP-126 gel, vehicle, or 1 of the 3 dyad gels [phase 2 only]) were included across the 3 studies (safety populations: n = 1,004). IDP-126 (deemed "moderately irritating") was significantly less irritating than commercially available BPO 2.5%/adapalene 0.3% gel. The results from these three studies show that the triple-combination IDP-126 had a positive safety profile and was well tolerated in healthy participants and those with moderate-to-severe acne."

Journal • Acne Vulgaris • Contact Dermatitis • Dermatitis • Dermatology • Immunology

FDA To Review New Drug Application for Triple-Combination IDP-126 Gel (LiVDerm) - "IDP-126 has been the topic of much discussion in recent months, with many dermatologists eager to see it become available to their patients. LiVDerm Advisory Board Member, Leon H. Kircik, MD has previously shared his own excitement, stating, 'It's going to be a very, very unique product that we expect to hit every aspect of acne treatment.'"

Media quote

Triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study. (PubMed, Pediatr Dermatol) - P2 | "IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne."

Clinical • Journal • P2 data • Acne Vulgaris • Pain • Pediatrics

Dermal Irritation, Sensitization, and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Gel in Healthy Participants (AAD 2023) - "Patches contained: IDP-126 gel, vehicle gel, saline 0.9% (RIPT/CIPT), sodium lauryl sulfate (SLS) 0.5% (CIPT), or branded BPO 2.5%/adapalene 0.3% gel (CIPT). Additionally, IDP-126 demonstrated significantly less irritation versus commercially available, branded BPO 2.5%/adapalene 0.3% gel. IDP-126 demonstrated good safety/tolerability, mirroring the phase 2 study results."

Clinical • Acne Vulgaris

Impact of Age or Sex on Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel in Participants with Moderate-to-Severe Acne (AAD 2023) - "IDP-126 polymeric mesh gel (clindamycin phosphate 1.2%/benzoyl peroxide [BPO] 3.1%/adapalene 0.15%) is the first triple-combination, fixed-dose acne topical in development. Most TEAEs were of mild-moderate severity in all groups. Fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated, regardless of age or sex, with approximately half of participants with moderate-to-severe acne achieving clear/almost clear skin."

Clinical • Acne Vulgaris • Pediatrics

Clinically Meaningful Improvement on the Acne Quality of Life Following Treatment with IDP-126 Gel for Moderate-to-Severe Acne: A Post Hoc Exploratory Pooled Analysis of Phase III Trial Data (AAD 2023) - "The proportion of responders was significantly higher (all p < 0.05) in the IDP-126 Gel group vs. vehicle for all Acne-QoL domains—self-perception (Odds Ratio [OR]:4.32, 95% Confidence Interval [CI]: 2.16-8.65), acne symptoms (OR:3.90, 95% CI: 2.11-7.23), role-social (OR:3.59, 95% CI: 1.73-7.47) and role-emotional (OR:2.50, 95% CI: 1.36-4.58). Overall, in this post hoc exploratory analysis of pooled data from two Phase III studies, participants with moderate-to-severe acne reported statistically significant and clinically meaningful improvements in all four Acne-QoL domains after 12 weeks of treatment with IDP-126 Gel."

HEOR • P3 data • Retrospective data • Acne Vulgaris

Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel (clinicaltrials.gov) - P2 | N=686 | Completed | Sponsor: Bausch Health Americas, Inc. | Recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel (clinicaltrials.gov) - P2 | N=660 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Jun 2022 ➔ Sep 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology