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"Benzoyl peroxide"
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Efficacy and Tolerability of a Novel Cosmetic and Over‐the‐Counter Facial Acne Regimen Versus a Prescription Treatment
by
Mehta, Rahul C.
,
Makino, Elizabeth T.
,
Supan, Olivia
in
acne vulgaris
,
Acne Vulgaris - diagnosis
,
Acne Vulgaris - drug therapy
2025
Background The SkinMedica Acne Treatment Platform (SM Regimen) was formulated to treat acne without overdrying the skin. We evaluated efficacy and tolerability of the SM Regimen (including a novel 1% salicylic acid Acne Clarifying Cleanser and 2% salicylic acid Acne Treatment Lotion) versus a prescription formulation (Rx Regimen; including adapalene 0.1%/benzoyl peroxide 2.5%) in a diverse population of adults with mild to moderate facial acne. Methods This single‐center, double‐blind, randomized study enrolled adults (18–45 years) with Fitzpatrick skin types (FST) I–VI. SM Regimen or Rx Regimen was applied topically to the entire face for 12 weeks. Assessments were conducted at 24 and 48 h and 4, 8, and 12 weeks. Results Subjects (SM Regimen, n = 31; Rx Regimen, n = 23) were primarily female (90.7%) with mean age of 28.6 years; 53.8% had FST IV–VI. Efficacy was comparable between regimens. The SM regimen resulted in significant improvements versus baseline in mean Investigator's Global Assessment of acne severity from 48 h through week 12 (p ≤ 0.001), as well as significant and sustained improvements from baseline in total acne lesion count, global postinflammatory hyperpigmentation/postinflammatory erythema, and oiliness. The SM Regimen was well tolerated at all time points, with mean scores below mild for all parameters; the Rx Regimen caused significantly more tightness/dry feeling at week 4 versus SM Regimen (p = 0.008). Subjects (> 96%) reported high satisfaction with the SM Regimen at all time points. Conclusions The SM Regimen reduced acne severity and skin oiliness, evening out skin tone without overdrying or irritating the skin.
Journal Article
Efficacy and safety of the 589/1319 nm solid-state dual-wavelength laser combined with topical benzoyl peroxide for inflammatory acne vulgaris: a split-face randomized controlled trial
by
Chirasuthat, Sonphet
,
Boonpethkaew, Suphagan
,
Ratanapokasatit, Yanisa
in
Acne
,
Acne Vulgaris - pathology
,
Acne Vulgaris - therapy
2025
The 589/1319 nm solid-state dual-wavelength (SSDW) laser, which does not require consumable dye, has the potential to target inflammation and sebum production in acne vulgaris pathogenesis. To assess the efficacy and safety of 598/1319 nm SSDW laser as an adjunctive treatment to conventional treatment, 18 patients with bilateral facial acne, with inflammatory papules or pustules, were recruited. Patients were instructed to apply 2.5% benozoyl peroxide (BPO), the drug for inflammatory acne, to their entire face throughout the study. One side of the face was randomly assigned to receive 4 sessions of 589/1319 nm SSDW laser treatments, administered every 2 weeks. After the last laser treatment, 3 monthly follow-ups were scheduled. Inflammatory lesion count (ILC) and acne-related skin parameters, including hemoglobin level, melanin level, skin depression, and skin roughness were measured. Adverse events (AEs) and patients’ satisfaction were assessed. At the 3-month follow-up, the ILC reduced by 46% on the adjunctive laser (BPO + laser) side (
p
= 0.0080), compared with a 29% reduction on the BPO monotherapy side (
p
= 0.1875). On the adjunctive laser side, the change in ILC positively correlated with the change in melanin level (
r
= 0.51,
p
= 0.0301) and showed a trend towards a positive correlation with the change in depression volume (
r
= 0.45,
p
= 0.0606) and roughness level (
r
= 0.42,
p
= 0.0806). The patients reported a pain score of 3.4 ± 2.3 on scale of 10. No serious AEs occurred. Patients’ satisfaction scores were higher with the adjunctive laser therapy, although this was not statistically significant (
p
= 0.2758). In conclusion, the 589/1319 nm SSDW laser provided a synergistic effect as an adjunctive treatment to BPO in inflammatory acne in terms of reducing ILC and improving post inflammatory hyperpigmentation without causing discomfort or downtime.
Journal Article
Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study
by
Weiss, Jonathan
,
Liu, Hong
,
Rueda, Maria Jose
in
Acne Vulgaris - drug therapy
,
Adapalene - administration & dosage
,
Adapalene - adverse effects
2016
Background
A need exists for topical treatments in managing more severe inflammatory acne.
Objectives
The objectives of this study were to evaluate the efficacy and safety of adapalene 0.3 %/benzoyl peroxide 2.5 % (0.3 % A/BPO) topical gel in subjects with moderate and severe inflammatory acne.
Methods
This was a multicenter, randomized, double-blind, parallel-group study. Randomization was stratified by acne severity (50 % moderate and 50 % severe). Subjects received 0.3 % A/BPO, 0.1 % A/BPO (benchmark), or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (the percentage of subjects rated ‘clear’ or ‘almost clear’ with at least a 2-grade improvement on Investigator’s Global Assessment [IGA]) and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
Results
A total of 503 subjects were randomized: 217, 217, and 69 subjects in the 0.3 % A/BPO, 0.1 % A/BPO, and vehicle groups, respectively. For success rate (subjects rated ‘clear’ or ‘almost clear’ with ≥2-grade improvement in IGA), 0.3 % A/BPO was superior to vehicle, with a treatment difference of 22.7 % (33.7 vs. 11.0 %; 95 % confidence interval [CI] 12.8–32.6,
p
< 0.001). At week 12, 0.3 % A/BPO was superior to vehicle for mean reduction from baseline in IN (27.0 vs. 14.4) and NIN lesion counts (40.2 vs. 18.5), as well as for percentage reduction from baseline in IN (68.7 vs. 39.2 %) and NIN lesion counts (68.3 vs. 37.4 %) (all
p
< 0.001). Among subjects with severe inflammatory acne (IGA = 4), 0.1 % A/BPO did not reach statistical significance for success rate compared with vehicle (
p
= 0.443), whereas 0.3 % A/BPO demonstrated significantly greater efficacy (
p
= 0.029, requiring ≥3-point IGA improvement). Additionally, 0.3 % A/BPO was safe and well-tolerated.
Conclusions
Results of this clinical trial demonstrate the significantly greater efficacy of adapalene 0.3 % A/BPO topical gel compared with vehicle as well as a good safety profile in the treatment of moderate to severe inflammatory non-nodulocystic acne, which increases patients’ treatment options.
Clinicaltrials.gov identifier
NCT01880320.
Journal Article
A randomized controlled double-blinded split-face prospective clinical trial to assess the efficacy, safety, and tolerability of a novel 3-step routine compared to benzoyl peroxide for the treatment of mild to moderate acne vulgaris
2024
Adult acne vulgaris affects up to 43–51% of individuals. While there are numerous treatment options for acne including topical, oral, and energy-based approaches, benzoyl peroxide (BPO) is a popular over the counter (OTC) treatment. Although BPO monotherapy has a long history of efficacy and safety, it suffers from several disadvantages, most notably, skin irritation, particularly for treatment naïve patients. In this prospective, randomized, controlled, split-face study, we evaluated the comparative efficacy, safety, and tolerability of a novel 3-step azelaic acid, salicylic acid, and graduated retinol regimen versus a common OTC BPO-based regimen over 12 weeks. A total of 37 adult subjects with self-reported mild to moderate acne vulgaris were recruited. A total of 21 subjects underwent a 2-week washout period and completed the full study with 3 dropping out due to product irritation from the BPO routine, and 13 being lost to follow-up. Detailed tolerability surveys were conducted at Week 4. Additional surveys on tolerability and product preferences were collected monthly, at Week 4, Week 8, and Week 12. A blinded board-certified dermatologist objectively scored the presence and type of acne lesions (open or closed comedones, papules, pustules, nodules, and cysts) at baseline, Week 4, Week 8, and Week 12. Patients photographed themselves and uploaded the images using personal mobile phones. Detailed Week 4 survey results showed across 25 domains of user-assessed product performance, the novel routine outperformed the BPO routine in 19 (76%) which included domains in preference (e.g. “I would use this in the future) and performance (“my skin improved” and “helped my acne clear up faster”). Users of the novel routine reported less facial redness, itching, and burning, though differences did not reach statistical significance. In terms of efficacy, both products performed similarly, reducing total acne lesions by 36% (novel routine) and 40% (BPO routine) by Week 12. Overall, accounting for user preferences and tolerability the novel routine was more preferred than the BPO routine in 79% of domains (22/28). Differences in objective acne lesion reduction were not statistically significant (p = 0.97). In a randomized split-face study, a 3-step azelaic acid, salicylic acid, and graduated retinol regimen delivered similar acne lesion reduction, fewer user dropouts, greater user tolerability, and higher use preference compared to a 3-step BPO routine based in a cohort of participants with mild-to-moderate acne vulgaris.
Journal Article
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
by
Callender, Valerie
,
Tanghetti, Emil A.
,
Pariser, David M.
in
Acne
,
Acne Vulgaris - drug therapy
,
Adapalene - administration & dosage
2022
Background
A 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.
Objectives
We 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.
Methods
In 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.
Results
A 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.
Conclusions
Once-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 Registration
ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).
Journal Article
Comparative efficacy of clindamycin phosphate with benzoyl peroxide versus clindamycin phosphate with adapalene in acne vulgaris: a systematic review and meta-analysis
by
Nadra, Raghad Waheed
,
Alshammari, Bushra
,
Alsaleh, Kawthar
in
692/699
,
692/699/4033
,
692/699/4033/4035
2025
Acne vulgaris is a common skin condition that significantly impacts both physical appearance and mental well-being. Acne, being a chronic skin condition, often requires continuous treatment. This study aims to evaluate the efficacy and safety of clindamycin phosphate 1.2%/benzoyl peroxide 3% compared to clindamycin phosphate 1.2%/adapalene 0.1% combinations for treating acne vulgaris. A systematic review and meta-analysis of randomized controlled trials were carried out following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, and three databases were searched to identify RCTs comparing CLIN/BPO with CLIN/ADAP. Primary outcomes included treatment-emergent adverse events, inflammatory and non-inflammatory lesion counts, and application site side effects. Statistical analyses were conducted using RevMan 5.3. The study included a total of 800 participants across three RCTs. The meta-analysis of three RCTs demonstrated a significantly lower risk of TEAEs with CLIN/BPO (OR = 0.49, 95% CI: 0.35–0.86,
p
< 0.001). CLIN/BPO also resulted in fewer application site side effects (OR = 0.33, 95% CI: 0.23–0.47,
p
< 0.001). However, no significant differences were observed between the groups for reducing inflammatory (MD = 1.34, 𝑝 = 0.121) or non-inflammatory lesion counts (MD = 0.04, 𝑝 = 0.98). The study concluded that although CLIN/BPO was associated with fewer side effects, both treatments were equally effective in reducing acne lesions. The favorable safety profile of CLIN/BPO, particularly regarding treatment-emergent and application-site adverse events, suggests it may be the more tolerable option for patients. Future studies with larger, more diverse populations are recommended to confirm these findings and explore long-term efficacy.
Journal Article
Antimicrobial and Anti-Inflammatory Activity of Chitosan–Alginate Nanoparticles: A Targeted Therapy for Cutaneous Pathogens
by
Schairer, David O.
,
Pirouz, Aslan
,
Liu, Phil T.
in
Acne
,
Acne Vulgaris - drug therapy
,
Administration, Topical
2013
Advances in nanotechnology have demonstrated potential application of nanoparticles (NPs) for effective and targeted drug delivery. Here we investigated the antimicrobial and immunological properties and the feasibility of using NPs to deliver antimicrobial agents to treat a cutaneous pathogen. NPs synthesized with chitosan and alginate demonstrated a direct antimicrobial activity in vitro against Propionibacterium acnes, the bacterium linked to the pathogenesis of acne. By electron microscopy (EM) imaging, chitosan–alginate NPs were found to induce the disruption of the P. acnes cell membrane, providing a mechanism for the bactericidal effect. The chitosan–alginate NPs also exhibited anti-inflammatory properties as they inhibited P. acnes-induced inflammatory cytokine production in human monocytes and keratinocytes. Furthermore, benzoyl peroxide (BP), a commonly used antiacne drug, was effectively encapsulated in the chitosan–alginate NPs and demonstrated superior antimicrobial activity against P. acnes compared with BP alone while demonstrating less toxicity to eukaryotic cells. Together, these data suggest the potential utility of topical delivery of chitosan–alginate NP-encapsulated drug therapy for the treatment of dermatologic conditions with infectious and inflammatory components.
Journal Article
Systematic review of antibiotic resistance in acne: an increasing topical and oral threat
by
Dréno, Brigitte
,
Efthimiou, John
,
Walsh, Timothy R
in
Acne
,
Acne Vulgaris - drug therapy
,
Acne Vulgaris - microbiology
2016
Topical and oral antibiotics are routinely used to treat acne. However, antibiotic resistance is increasing, with many countries reporting that more than 50% of Propionibacterium acnes strains are resistant to topical macrolides, making them less effective. We reviewed the current scientific literature to enable proposal of recommendations for antibiotic use in acne treatment. References were identified through PubMed searches for articles published from January, 1954, to March 7, 2015, using four multiword searches. Ideally, benzoyl peroxide in combination with a topical retinoid should be used instead of a topical antibiotic to minimise the impact of resistance. Oral antibiotics still have a role in the treatment of moderate-to-severe acne, but only with a topical retinoid, benzoyl peroxide, or their combination, and ideally for no longer than 3 months. To limit resistance, it is recommended that benzoyl peroxide should always be added when long-term oral antibiotic use is deemed necessary. The benefit-to-risk ratio of long-term antibiotic use should be carefully considered and, in particular, use alone avoided where possible. There is a need to treat acne with effective alternatives to antibiotics to reduce the likelihood of resistance.
Journal Article
Long-Term Effectiveness and Safety of Up to 48 Weeks’ Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne
by
Tan, Jerry
,
Gagné-Henley, Angélique
,
Lynde, Charles
in
Acne
,
Acne Vulgaris - complications
,
Acne Vulgaris - diagnosis
2019
Background
Scarring is a frequent consequence of acne.
Objectives
Our objective was to evaluate the effect of up to 48 weeks’ treatment with adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) gel on atrophic scars in moderate or severe acne vulgaris.
Methods
In Part 1 of this two-part study, A0.3/BPO2.5 gel or vehicle was applied on each half-face for 24 weeks in a randomized, investigator-blinded, split-face design. Part 2 was a 24-week, open-label extension phase during which A0.3/BPO2.5 gel was applied on both sides of the face. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, local tolerability, and safety.
Results
Of the 45 subjects entering Part 2, 41 completed the 48-week study. At baseline (Part 1), most subjects had moderate acne (93.3%) with mild scars (62.2%). The scar count decrease from baseline was 21.7% at week 24 and 26.9% at week 48 on the half-face treated for 48 weeks with A0.3/BPO2.5. For the half-face treated with vehicle followed by 24 weeks’ A0.3/BPO2.5, scar count increased by 16.7% at week 24 (under vehicle) and decreased by 22.7% between weeks 24 and 48. The half-face that received 48 weeks’ A0.3/BPO2.5 had a lower final atrophic scar count (mean 8.4 vs. 9.9 for the half-face with 24 weeks’ vehicle then 24 weeks’ A0.3/BPO2.5) and a higher percentage of SGA clear/almost clear. High reductions in acne lesions between baseline and week 48 were observed for both sides of the face. Long-term treatment with A0.3/BPO2.5 was safe and well-tolerated.
Conclusions
Reductions in atrophic acne scars and acne lesions observed after 24 weeks of treatment with A0.3/BPO2.5 gel were maintained with treatment up to 48 weeks. The additional improvement in atrophic scar count with 48 weeks’ A0.3/BPO2.5 treatment, compared to delayed application at 24 weeks, highlights the importance of early initiation of effective acne treatment to prevent and reduce the formation of acne scars.
Trial registration
ClinicalTrials.gov identifier NCT02735421.
Journal Article
Development and Validation of an HPLC-DAD Method for the Quantitative Determination of Benzoyl Peroxide, Curcumin, Rosmarinic Acid, Resveratrol and Salicylic Acid in a Face Mask—In Vitro/Ex Vivo Permeability Study
2025
Acne is a common skin condition that causes pimples, redness and inflammation. Benzoyl peroxide (BENZ), salicylic acid (SAL), curcumin (CUR), rosmarinic acid (ROS) and resveratrol (RESV) exhibit antimicrobial, anti-inflammatory and antioxidant properties and are recommended for its treatment. These five active pharmaceutical ingredients (APIs) were incorporated into a green clay, honey and gelatin face mask and determined by an HPLC-DAD (diode array) method. For the chromatographic separation of the analytes, a gradient mobile phase with two solvents mixtures: A, comprising H2O with 0.1% TFA-ACN with 0.1% TFA, 85:15 v/v, and B, comprising 100% ACN with 0.1% TFA, and a C18 column (250 × 4.6 mm, 5 μm), at 40 °C (diluent: MeOH-ACN 0.1% TFA 2:1 v/v), were selected. The method was validated according to the ICH guidelines for pharmaceutical products (R2 > 0.999, %RSD < 1.2, % Recovery > 98.2, LODμg/mL: ROS = 0.267, RES = 0.047, SAL = 0.636, CUR = 0.296 and BENZ = 0.083). For the processing of mask samples and the quantitative extraction of the analytes, the “D-optima mixture” experimental design methodology was applied (% Recovery 95.4–102.1%, %RSD < 2.4). Finally, the permeability rate (Papp) of the mask ingredients through the skin was studied using Franz vertical diffusion cells, in a cellulose membrane (in vitro), in rat tissue and in human skin (ex vivo). To ensure the reliability of the results, APIs’ stability rate under the given experimental conditions was studied. In addition, a second method for sample processing in Franz cells was developed and validated (% Recovery > 90.6–106.9, %RSD < 5.2). Based on the results obtained, both the effectiveness of the new face mask formulation and the suitability of the membranes were evaluated.
Journal Article