Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1%Compared With Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Participants With Moderate to Severe Acne

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose, triple-combination formulation approved for the treatment of acne, and is indicated in patients 12 years of age and older. In 3 clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. To better understand the efficacy and safety of CAB gel in patients with darker skin phototypes, this post hoc analysis included participants who self-identified as ‘Black or African American’ (hereafter referred to as Black). Methods: Data were pooled from a phase 2 (N=741) and two phase 3 (N=183; N=180), double-blind, randomized, 12-week studies. Participants aged ≥9 years with moderate to severe acne were randomized to receive once-daily CAB or vehicle gel. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in inflammatory/ noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were also assessed. Results: Of 657 participants randomized to CAB or vehicle gel, 104 (15.8%) self-identified as Black (n=64 CAB, n=40 vehicle). At week 12, 31.5% of Black participants treated with CAB achieved treatment success, compared to 17.3% with vehicle. Inflammatory lesion reductions with CAB were significantly greater than with vehicle (69.0% vs 53.6%, P<0.01), and noninflammatory lesion reductions were numerically greater with CAB than with vehicle (58.3% vs 51.9%). The rate of TEAEs with CAB treatment in Black participants was generally lower than in the overall study population (23.4% vs 24.6-36.2%), and most TEAEs were of mild-to-moderate severity. Conclusions: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in Black participants with moderate-to-severe acne. Despite the limited number of self-identified Black participants across the clinical studies of CAB gel, these post hoc analyses add valuable information to the limited literature describing treatment effects of fixed-dose combination acne treatments in Black individuals. Funding: Ortho Dermatologics

Introduction: For most patients with acne, combination treatments targeting multiple pathogenic processes are recommended. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% (CAB) gel is the only fixed-dose, triple-combination topical approved for acne. Analyses were conducted to compare the efficacy and safety of topical fixed-combination CAB gel vs 3 constituent dyad gels and commercially available adapalene 0.3%/BPO 2.5% gel across 4 clinical trials. Methods: In pooled, post hoc analyses of two phase 2 (one head-to-head) and two phase 3 randomized, double-blind, 12-week clinical trials, CAB gel (n=618), 3 constituent dyad gels (n=146 or 150 each), commercially available adapalene 0.3%/BPO 2.5% gel (n=226), and vehicle (n=497) were compared in participants with moderate-to-severe acne. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin), least-squares mean percent change from baseline in inflammatory/ noninflammatory lesion counts, and treatment-emergent adverse events (TEAEs). Results: By week 12, >50% of CAB-treated participants achieved treatment success (51.0%), significantly more than approximately 33% treated with dyads or adapalene 0.3%/BPO 2.5% (range, 30.7%-35.8%) and <20% treated with vehicle (18.3%; P≤0.001, all). Inflammatory/noninflammatory lesion reductions at week 12 were significantly greater with CAB (76.9%/71.8%) versus dyads (range, 64.2%-69.2%/59.1%-61.1%; P<0.001, all), adapalene 0.3%/BPO 2.5% (73.0%/67.5%; P<0.05, both), and vehicle (52.9%/46.6%; P<0.001, both). Most TEAEs were mild-moderate in severity across all groups. TEAE rates for CAB and both adapalene/BPO gels were similar, indicating the addition of clindamycin did not worsen tolerability. Conclusions: CAB triple-combination gel demonstrated significantly greater efficacy vs component dyads and commercially available adapalene 0.3%/BPO 2.5% gel in this 4-trial pooled analysis. By week 12, CAB-treated participants had ~77% reduction in inflammatory lesion counts and half achieved clear/almost clear skin. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head trial of topical combination acne treatments. Funding: Ortho Dermatologics

Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most acne patients. A three-pronged approach using an antibiotic, retinoid, and antibacterial may also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies. Methods: Two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a co-primary endpoint. Other co-primary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies. Results: Across studies, approximately half of CAB-treated participants achieved treatment success by week 12 (range: 49.6-52.5%) versus less than one-fourth with vehicle (range: 8.1%-24.9%; P<0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8%-32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P<0.01, all). NNT values for CAB (3-5) were lower (better) than for constituent dyads (5-6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were <1 (mild) at all timepoints. Conclusions: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment may result in clinical success more often than two-ingredient combination products. Funding: Ortho Dermatologics.

Introduction: Acne vulgaris is a common skin condition with significant impact on Asian patients. Because clinical presentation of acne varies across different populations, it is important to consider patient demographics to improve treatment outcomes. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only triple-combination formulation approved for acne. In phase 2 and 3 clinical trials of participants with moderate to severe acne, CAB was more efficacious than vehicle (treatment success: ~50% vs 8%-25%; inflammatory lesion [IL]/noninflammatory lesion [NL] reductions: 71%-80% vs 46%-60%) with favorable safety/tolerability. This post hoc analysis evaluated the efficacy and safety of CAB in Asian participants. Methods: Data were pooled from two phase 2 (NCT03170388, NCT04892706) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week trials in which 1115 participants aged ≥9 years (≥12 in NCT04892706) with moderate to severe acne were randomized to once-daily CAB or vehicle gel; additional randomization arms are not included here. Analyses were performed using data from participants who self-identified as Asian. Endpoints included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in IL/NL counts at week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed. Results: A total of 96 Asian participants were included in this analysis (CAB, n=47; vehicle gel, n=49). At week 12, 66.5% of CAB-treated participants achieved treatment success, which was significantly greater compared with vehicle-treated participants (23.4%; P<0.001). CAB-treated participants experienced 87.7% reductions in IL and 80.3% reductions in NL counts, significantly greater versus vehicle (58.3% and 55.7%, respectively; P≤0.001, both). Rate of TEAEs in CAB-treated Asian participants was similar to those of the overall study populations (27.7% vs 24.6%-36.2%). Most TEAEs were mild or moderate severity and no serious AEs occurred. Hyperpigmentation mean scores stayed below the baseline value (0.7; 1=mild) at all time points. Conclusions: In this pooled analysis, 12 weeks of once-daily CAB treatment in Asian participants with moderate to severe acne led to a treatment success rate of 66.5%, and >80% acne lesion reductions, with favorable safety/tolerability. These improvements are numerically greater than results in the overall study populations, indicating that triple-combination CAB is well suited for acne treatment in Asian patients

Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents.
 Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2).
 Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged <12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study.
 Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12.
 Funding: Ortho Dermatologics

BackgroundA three-pronged approach to acne treatment—combining an antibiotic, antibacterial, and retinoid—could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance.ObjectivesWe aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne.MethodsIn a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed.ResultsA total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8–30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6–26.8; noninflammatory, 21.8–30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity.ConclusionsOnce-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne.Clinical Trial RegistrationClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).Supplementary InformationThe online version contains supplementary material available at 10.1007/s40257-021-00650-3.

A three-pronged acne treatment approach-combining an antibiotic, antibacterial agent, and retinoid-may provide greater efficacy than single/double treatments. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (IDP-126) is the first fixed-dose triple-combination in development for acne. To confirm efficacy, safety, and tolerability of IDP-126 gel in acne treatment. Two phase 3, double-blind, 12-week studies randomized participants aged ≥9years with moderate-to-severe acne (N=183; N=180) 2:1 to once-daily IDP-126 or vehicle gel. Co-primary endpoints comprised participants achieving ≥2-grade reduction from baseline in Evaluator's Global Severity Score (EGSS) and clear/almost clear skin (treatment success) and change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed. At week 12, 49.6% and 50.5% of participants achieved treatment success with IDP-126 versus 24.9% and 20.5% with vehicle (P<.01, both). IDP-126 also provided significantly greater reductions in inflammatory/noninflammatory lesions versus vehicle (least-squares mean percent range: 72.7% to 80.1% vs 47.6% to 59.6%; P<.001, all). Most TEAEs were of mild-moderate severity. Inter-observer bias/variation in acne severity ratings, limited treatment duration, and population differences that may not generalize to real-world populations. 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.

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose, triple-combination formulation approved for the treatment of acne. In three clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. As acne pathogenesis and treatment outcomes can vary with age, this post hoc analysis was performed to evaluate the efficacy and safety of CAB in pediatric and adolescent participants (aged 9-24 years) versus adult participants (≥25 years). This age cutoff was chosen as acne in patients aged 18-24 years is more similar to adolescents than adults, and age 25 is often used to define “adult acne”. Methods: In a phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (defined as ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at week 12. Treatment-emergent adverse events (TEAEs) were also assessed. Pooled data across all three studies were analyzed for participants aged 9-24 years (CAB: n=297; vehicle: n=218) or ≥25 years (n=91; n=51). Results: At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24 years: 50.6%; ≥25: 49.0%) versus less than one-fourth with vehicle (15.7% and 20.6%; P&lt;0.01, both). Treatment with CAB resulted in &gt;70% reductions from baseline in inflammatory and noninflammatory lesions in both age groups, versus 45%-62% with vehicle (P≤0.001, all). There were no significant differences between CAB-treated participants in the two age groups across any of these efficacy endpoints (P=0.68-0.97). Most TEAEs with CAB were of mild-moderate severity, with no age-related trends in safety/tolerability. Conclusions: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of pediatric/adolescent and adult participants achieved clear/almost clear skin with CAB, and lesion count reductions of &gt;70% were observed. Funding: Ortho Dermatologics

Introduction: The main goal of acne treatment is to clear lesions quickly to manage and/or mitigate sequelae. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In three published clinical studies of participants with moderate to severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. Herein are presented detailed efficacy and safety data from 5 clinical study patients to document their CAB treatment journey. Methods: In two phase 3 (NCT04214652, NCT04214639), double-blind, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and percent change from baseline in inflammatory/ noninflammatory lesion counts. Dosing compliance, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. Descriptive data from 5 selected cases who completed 12 weeks of CAB treatment are summarized. Results: Participants (n=5) ranged from 13-32 years. At week 12, 3 achieved treatment success, 1 achieved a 2-grade reduction from severe to mild, and 1 achieved a 1-grade reduction from moderate to mild. Reductions from baseline to week 12 in inflammatory/ noninflammatory lesion counts ranged from 74.7-100%. No participants reported TEAEs/serious AEs. Some cutaneous safety/tolerability scores increased at weeks 2, 4, or 8, but generally decreased back to/below baselines levels by week 12, similar to the overall study populations. Most scores at week 12 were 0 (none) or 1 (mild), with only one participant reporting scores of 2 (moderate) for itching, burning, and stinging. Conclusions: In the overall phase 3 clinical trials, fixed-dose, triple-combination CAB gel has demonstrated good efficacy, safety, and tolerability. All 5 cases presented here achieved substantial (&gt;70%) acne lesion reductions, with 4/5 cases achieving treatment success or a 2-grade EGSS reduction by week 12. While patterns in cutaneous safety/tolerability were variable across cases, transient increases with CAB generally resolved to baseline values within two months of treatment. These clinical study cases reinforce the importance of patient education regarding efficacy and safety of acne treatment, including the importance of treatment adherence, managing patient expectations, and the potential for cutaneous effects, which are often transient. Support: Ortho Dermatologics

Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the first fixed-dose triple-combination approved for the treatment of acne. This post hoc analysis investigated the efficacy and safety of CAB in pediatric (&lt;18 years) and adult (greater than or equal to 18 years) participants. In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants greater than or equal to 9 years of age with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed for pediatric and adult subpopulations. Assessments included treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear], inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. At week 12, treatment success rates for both pediatric and adult participants were significantly greater with CAB (52.7%; 45.9%) than with vehicle (24.0%; 23.5%; P&lt;0.01, both). CAB-treated participants in both subgroups experienced greater reductions from baseline versus vehicle in inflammatory (pediatric: 78.6% vs 50.4%; adult: 76.6% vs 62.8%; P&lt;0.001, both) and noninflammatory lesions (pediatric: 73.8% vs 41.1%; adult: 70.7% vs 52.2%; P&lt;0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than with a vehicle. Most TEAEs were of mild-to-moderate severity; no age-related trends for safety/tolerability were observed.&nbsp; Conclusions: CAB gel demonstrated comparable efficacy, quality of life improvements, and safety in pediatric and adult participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment option for patients with acne. J Drugs Dermatol. 2024;23(6):394-402.&nbsp; &nbsp;&nbsp; doi:10.36849/JDD.8357.

Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose triple-combination approved for acne (indicated in patients 12 years and older). As topical acne treatment in pediatric patients may be complicated by tolerability and/or a perceived lack of efficacy, post hoc analyses were used to investigate efficacy/safety of CAB in children and adolescents. Data were pooled from 2 phase 3, double-blind, 12-week studies (NCT04214639; NCT04214652). Participants aged 9 years and older with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. Endpoints included treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesions. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. Post hoc analyses were conducted in adolescents aged 12 to 17 years (CAB, n=123; vehicle, n=50) with descriptive data shown for children aged 10 to 11 (CAB, n=3; vehicle, n=2). At week 12, 51.5% of CAB-treated adolescents achieved treatment success vs 24.9% with vehicle (P&lt;0.01). CAB also provided inflammatory/noninflammatory lesion reductions of 78.3%/73.7% vs 50.5%/42.9% with vehicle (P&lt;0.001, both). Most TEAEs were of mild-to-moderate severity, and &lt;2.5% of participants discontinued due to adverse events. Only the 3 children treated with CAB achieved treatment success, with lesion reductions ranging from 76% to 100%. One CAB-treated child experienced TEAEs and none discontinued. In 2 pooled phase 3 studies, once-daily CAB gel was well tolerated and efficacious in pediatric participants with acne, with over half achieving treatment success at week 12. J Drugs Dermatol. 2024;23(12):1049-1057. doi:10.36849/JDD.8643.

Background: A three-pronged approach to acne treatment that combines an antibiotic, antimicrobial agent, and retinoid in a single formulation may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. IDP-126 polymeric mesh 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 a phase 2 and two phase 3 studies of moderate-to-severe acne. This post hoc analysis further examined efficacy and safety of IDP-126 in data pooled from these phase 3 studies.&#x0D; Methods: In two identical phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, randomized, 12-week studies, participants aged ≥9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily IDP-126 or vehicle gel. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated.&#x0D; Results: A total of 363 participants were randomized; a majority were female (58.4%) and had moderate acne (91.2%). At week 12, 50.0% of participants achieved treatment success with IDP-126 versus 22.6% with vehicle gel (P&lt;0.001). IDP-126 resulted in over 70% reductions in inflammatory and noninflammatory lesions at week 12, which were significantly greater than vehicle (inflammatory: 77.9% vs 57.9%, respectively; noninflammatory: 73.0% vs 48.2%; P&lt;0.001, both). Most TEAEs were of mild-moderate severity, and &lt;3% of IDP-126-treated participants discontinued study/treatment due to AEs. Transient increases from baseline in investigator-assessed scaling and erythema and participant-assessed itching, burning, and stinging were observed with IDP-126, but resolved back to or near baseline values by week 12.&#x0D; Conclusions: The innovative fixed-dose triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear or almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products.&#x0D; Funding: Ortho Dermatologics

Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.

Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented. In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases. By week 12, all cases achieved &gt;70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12. In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (&gt;70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.

Introduction Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In phase 2 and 3 studies, CAB demonstrated superior efficacy to vehicle and component dyads. This post hoc analysis examined efficacy/tolerability of CAB in 147 self-identified Hispanic/Latino participants (referred to as Hispanic). Methods Data were pooled from one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week studies. Eligible participants aged ≥9 years with moderate to severe acne were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score with clear/almost clear skin (treatment success) and inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed. Results At week 12, 56.2% of CAB-treated participants achieved treatment success vs 18.4% with vehicle (p < 0.001). Reductions in inflammatory/noninflammatory lesions were 77.1%/76.2% with CAB vs 56.4%/45.0% with vehicle, respectively (p < 0.001, all). CAB TEAE rates were similar to overall study populations (27.0% vs 24.6%-36.2%). Baseline hyperpigmentation scores decreased from 0.6 to 0.3 (1 = mild) at week 12 with CAB. CAB gel was efficacious, safe, and well tolerated in Hispanic participants. Limitations include lack of Fitzpatrick skin phototype and short study duration. Conclusions This study provides support for acne treatment with CAB in ethnically diverse populations.