Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars.
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SUBMITTER: Loss MJ
PROVIDER: S-EPMC6002315 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundVery few clinical trials have investigated the effect of topical acne treatment on scarring.ObjectivesOur objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne.MethodsIn this multicenter, randomized, investigator-blinded, vehicle-controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; ≥ 25 inflammatory lesions; ten or more atrophic acne scars) applied A0.3/BPO2.5 or vehicle daily per half face for 24 weeks. Subjects with acne requiring systemic treatment were excluded. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, IGA, skin roughness and skin texture, subject self-assessment of clinical acne-related scars and satisfaction questionnaire, tolerability, and safety.ResultsIncluded subjects (n = 67) had mainly moderate acne (92.5% IGA 3); mean scores at baseline were approximately 40 acne lesions and 12 scars per half face. By week 24, the change from baseline in total scar count was - 15.5% for A0.3/BPO2.5 versus + 14.4% for vehicle (approximately 30% difference), with a mean of 9.5 scars versus 13.3 per half face, respectively (p < 0.0001). For SGA at week 24, a total of 32.9% with A0.3/BPO2.5 versus 16.4% with vehicle (p < 0.01) were clear/almost clear. Inflammatory acne lesions decreased by 86.7% for A0.3/BPO2.5 versus 57.9% for vehicle (p < 0.0001), and 64.2 versus 19.4% of subjects, respectively, were IGA clear/almost clear (p < 0.0001) at week 24. Treatment-related AEs were reported by 20.9% for A0.3/BPO2.5 versus 9% for vehicle side, most commonly skin irritation (14.9 vs. 6%, respectively).ConclusionsTopical A0.3/BPO2.5 prevented and reduced atrophic scar formation. Scar count increased with vehicle (+ 14.4%) but decreased with A0.3/BPO2.5 (- 15.5%) over 24 weeks.Trial registryClinicalTrials.gov identifier NCT02735421.
| S-EPMC5978908 | biostudies-literature
Project description:In our pursuit of enhancing acne treatment while minimizing side effects, we developed tailored Adapalene microsponges (MS) optimized using a Box-Behnken design 33. The independent variables, Eudragit RS100 percentage in the polymer mixture, organic phase volume, and drug to polymer percentage, were explored. The optimized formulation exhibited remarkable characteristics, with a 98.3% ± 1.6 production yield, 97.3% ± 1.64 entrapment efficiency, and a particle size of 31.8 ± 1.1 µm. Notably, it achieved a 24 h cumulative drug release of 75.1% ± 1.4. To delve deeper into its efficacy, we evaluated the optimized microspongeal-gel in vitro, in vivo, and clinically. It demonstrated impressive retention in the pilosebaceous unit, a target for acne treatment. Comparative studies between our optimized Adapalene microspongeal gel and marketed Adapalene revealed superior performance. In vivo studies on Propionibacterium acnes-infected mice ears showed a remarkable 97% reduction in ear thickness, accompanied by a significant decrease in inflammatory signs and NF-κB levels, as confirmed by histopathological and histochemical examination. Moreover, in preliminary clinical evaluation, it demonstrated outstanding effectiveness in reducing comedonal lesions while causing fewer irritations. This not only indicates its potential for clinical application but also underscores its ability to enhance patient satisfaction, paving the way for future commercialization.
| S-EPMC10791745 | biostudies-literature
Project description:BackgroundAtrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited.MethodsIn this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 μg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts.ResultsAt week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity.ConclusionsTrifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2.Trial registrationClinicaltrials.gov NCT04856904.
| S-EPMC10689318 | biostudies-literature
Project description:IntroductionAcne scarring is a common undesirable complication of acne vulgaris. Fractional erbium-yttrium aluminum garnet (YAG) 2940 nm laser and platelet-rich plasma have been used in treating acne scars with variable outcomes. The objective of this study is to assess the efficacy of fractional erbium-YAG 2940 nm laser and platelet-rich plasma as a single line of treatment in comparison with combined treatment in atrophic postacne scars.MethodsSeventy-five patients were included in this trial and randomized into three equal groups (25 each). Group A was subjected to six sessions of erbium-YAG laser for 6 months, group B was treated with 12 sessions of platelet-rich plasma over the same period, and group C was subjected to six sessions of erbium-YAG laser plus 12 sessions of platelet-rich plasma over the same period. Each subject was evaluated by acne scar grading, photography, and subjective evaluation.ResultsBoth treatment modalities showed improvement of acne scars, but the improvement with combined treatment was better than that with erbium-YAG laser or platelet-rich plasma alone regarding scar grade improvement (P = 0.007 and 0.001), clinical improvement (P = 0.001 and 0.001), and patient satisfaction (P = 0.005 and 0.001), respectively.ConclusionsThe combination of platelet-rich plasma plus erbium-YAG laser is superior to either treatment alone for acne scars, with trivial side effects for all treatment modalities.Trial registrationClinicalTrials.gov identifier; NCT03933033.
| S-EPMC6828880 | biostudies-literature
Project description:Adapalene (AD) is an FDA-approved drug that shows good therapeutic efficacy for the treatment of acne vulgaris. However, due to its negative charge, AD cannot efficiently penetrate across the also negatively-charged skin membrane. This study is the first to assess the treatment of acne vulgaris using electrostatically optimized AD emulsions prepared using anionic AD with methoxy polyethylene glycol-b-poly(ε-caprolactone) (MC) as an anionic emulsifier coupled with a newly synthesized MC with different contents of an amine pendant-group (MC-[NH2]x) as a cationic emulsifier. The AD emulsion prepared using MC-[NH2]x with high cationic charge potential was significantly stable in the short-term studies compared with anionic MC or no emulsifier. Furthermore, the AD emulsion prepared with the cationic MC-[NH2]x emulsifier provided a two or three times stronger therapeutic effect against acne vulgaris than the AD emulsion prepared with the anionic MC emulsifier or no emulsifier in an animal study. Additionally, the AD emulsion with high cationic charge potential exerted a remarkable inhibition of macrophage expression, as confirmed by histological analysis. Therefore, the electrostatic interaction between the negatively-charged skin membrane and the AD emulsion prepared with the cationic MC-[NH2]x emulsifier provides a promising therapeutic strategy for acne vulgaris.
| S-EPMC9254491 | biostudies-literature
Project description:BackgroundAcne affects more than 80% of adolescents and young adults, who most often develop acne scars. Supporting data on the effect of acne scars on patient's health-related quality of life (HRQOL) are limited.ObjectiveThe aim was to determine how the severity of acne scars impacts the HRQOL of afflicted individuals.MethodsIn this population-based cross-sectional study, 723 adults with facial acne scars but without active acne lesions self-completed the Self-assessment of Clinical Acne-Related Scars (SCARS) questionnaire formulated to investigate degree of acne scarring. The Facial Acne Scar Quality of Life (FASQoL), Dermatology Life Quality Index (DLQI), and Dysmorphic Concern Questionnaire (DCQ) were completed to assess the attitude of these patients toward their scars and the impact of scarring on their HRQOL.ResultsThe mean (standard error) DLQI score for facial acne scars was 6.26 (0.22). Acne scars were considered a 'very large' or 'extremely large' concern by 19.3% of participants with mild scars as compared to 20.1% and 34.0% of participants with moderate and severe/very severe scars, respectively (P = 0.003). Higher FASQoL scores were associated with increased severity of scarring (P = 0.001). In total, 16.9% of participants had clinical features of dysmorphia (i.e., DCQ > 13). DCQ scores were significantly higher among participants with more severe scarring (mean DCQ score of 8.04 [0.28], 8.40 [0.18], and 10.13 [0.08] among participants with mild, moderate, and severe/very severe acne scars, respectively; P = 0.001). Most commonly reported signs of emotional distress were self-consciousness (68.0%) and worry about scars not going away (74.8%).ConclusionsThis study highlights the significant psychosocial impact of atrophic acne scars in the form of embarrassment and self-consciousness. Individuals with mild scars also expressed significant impact on quality of life that increased with aggravation of scar severity. Patient-reported outcomes provide an insight into the physical, functional, and psychological impact of acne scarring from the patient's perspective.
| S-EPMC8776674 | biostudies-literature
Project description:ImportanceEvidence is robust for the effectiveness of microneedle therapy in the management of postacne atrophic scarring. A home-based topical treatment with an efficacy comparable to microneedling would be a useful addition in the armamentarium of acne scar management.ObjectiveTo compare the efficacy of topical tazarotene gel, 0.1%, with microneedling therapy in the management of moderate to severe atrophic acne scars.Design, setting, and participantsProspective, observer-blinded, active-controlled, randomized clinical trial with 6 months of follow-up conducted between June 2, 2017, and February 28, 2018, at a tertiary care hospital in India. Thirty-six patients with grade 2 to 4 facial atrophic postacne scars and without a history of procedural treatment of acne scars within the previous year were recruited. Analyses were conducted using data from the evaluable population.InterventionsBoth halves of each participant's face were randomized to receive either microneedling or topical tazarotene therapy. Microneedling was conducted on 1 side of the face with a dermaroller having a needle length of 1.5 mm for a total of 4 sessions during the course of 3 months. Participants were instructed to apply topical tazarotene gel, 0.1%, to the other side of the face once every night during this same period.Main outcomes and measuresPatients were followed up at 3 and 6 months by a blinded observer, and improvements in acne scar severity based on Goodman and Baron quantitative and qualitative scores and a subjective independent dermatologist score (range, 0-10, with higher scores indicating better improvement) were assessed. Patient satisfaction was assessed using a patient global assessment score (ranging from 0 for no response to 10 for maximum improvement) at these follow-up visits.ResultsThere were 36 participants (13 men and 23 women; mean [range] age, 23.4 [18-30] years), and the median (interquartile range [IQR]) duration of acne was 6 (4-8) years. For the 34 participants included in the complete data analyses, the median (IQR) quantitative score for acne scar severity at the 6-month follow-up visit following treatment with either tazarotene (from a baseline of 8.0 [6.0-9.8] to 5.0 [3.0-6.0]) or microneedling (from a baseline of 7.0 [6.0-10.8] to 4.5 [3.0-6.0]) indicated significant improvement (P < .001) that was comparable for both treatments (median [IQR] change in severity score from baseline, 2.5 [2.0-4.0] vs 3.0 [2.0-4.0]; P = .42). By contrast, median qualitative acne scar scores were the same for both treatment groups at baseline and did not significantly change following either treatment.Conclusions and relevanceThe present clinical trial showed comparable outcomes of both treatments for the overall improvement of quantitative facial acne scar severity.Level of evidence1.Trial registrationClinicalTrials.gov identifier: NCT03170596.
| S-EPMC6439800 | biostudies-literature
Project description:A need exists for topical treatments in managing more severe inflammatory acne.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.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.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.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.NCT01880320.
| S-EPMC4863916 | biostudies-literature
Project description: Not available
| S-EPMC7069546 | biostudies-literature
Project description:IntroductionAcne is a chronic inflammatory disease. Key to a patient's success on fixed-dose adapalene-benzoyl peroxide (BPO) gel is ensuring adherence. Use of a pump system to deliver a pre-measured amount of gel with each pressure enables application of a more consistent dose vs. the tube, which should improve adherence. In the present study, we evaluate patient preference for two different containers for dispensing adapalene-BPO gel.MethodsIn this 15-day, open-label study, 300 subjects were asked to treat their acne using fixed-dose adapalene 0.1%-BPO 2.5% gel dispensed in either a tube or a pump once-daily for up to 7 days. At week 1, subjects switched to the alternative packaging design for the same timeframe. At the end of the treatment period, subjects were asked to complete a subject preference survey.ResultsAmong subjects completing the survey (n = 291), 79.0% (n = 230) preferred the pump for dispensing adapalene-BPO gel and 21.0% (n = 61) preferred the tube (p < 0.001). The top three characteristics of the pump were that it was easy to use (89.0%; n = 259/291), clean (73.2%; n = 213/291) and convenient (69.4%; n = 202/291). When asked to rate their experience with using the pump, 91.8% (n = 267/291; p < 0.001) of subjects reported being satisfied on a self-assessment scale. The majority of subjects stated they would tell their doctor about their preference for the pump next time adapalene-BPO gel was prescribed (76.6%; n = 223/291; p < 0.001) and would prefer the pump if both containers cost the same amount (80.1%; n = 233/291; p < 0.001).ConclusionPatients prefer using a pump instead of a tube to dispense adapalene-BPO gel. This delivery mechanism helps to ensure consistent application and thus may improve patient adherence to the prescribed acne treatment regimen.
| S-EPMC4065281 | biostudies-literature