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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.
Stein Gold, L, Baldwin, H, Kircik, LH, Weiss, JS, Pariser, DM, Callender, V, Lain, E, Gold, M, Beer, K, Draelos, Z, et al
American journal of clinical dermatology. 2022;(1):93-104
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Abstract
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).
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Evaluation of the changes in sebum, moisturization and elasticity in acne vulgaris patients receiving systemic isotretinoin treatment.
Gencebay, G, Aşkın, Ö, Serdaroğlu, S
Cutaneous and ocular toxicology. 2021;(2):140-144
Abstract
AIM: The aim of this study was to determine the change in facial skin sebum, hydration and elasticity of acne vulgaris patients after being treated with systemic isotretinoin. METHOD Patients who were diagnosed with acne vulgaris and who received systemic isotretinoin treatment for 6 months in Cerrahpaşa Medical Faculty Department of Dermatology between June 2012 and May 2017 were included in this study. The sebum, hydration and elasticity of the skin were measured non-invasively with a device called "Soft Plus Skin Analyses System" before treatment and 6 months after treatment. The relationship between the pre-treatment and post-treatment values were evaluated statistically. 35 adult patients (20 female, 15 male) who were diagnosed with acne vulgaris and who received systemic isotretinoin treatment for 6 months. RESULTS The pre-treatment sebum value for both sexes ranged between 5 and 100 and the mean value was calculated as 75.8 ± 28.0. The post-treatment sebum values ranged between 1 and 98 and the mean value was calculated as 48.4 ± 31.8. The difference between the pre-treatment and post-treatment values was statistically significant, p < 0.001. The decline in sebum value after treatment was 36%. The pre-treatment hydration values ranged between 9 and 77.5 and the mean was 34.6 ± 14.6. The post treatment hydration values ranged between 4.8 and 100 and the mean was calculated as 62.4 ± 28.6. The difference between the pre-treatment and post-treatment hydration values were statistically significant, p < 0.001. The post-treatment increase in hydration was 79%. The pre-treatment skin elasticity ranged between 28 and 50; the mean was 40.4 ± 5.5. The post-treatment elasticity values ranged between 20 and 50; and the mean was 37.5 ± 8.2. However, the difference was not statistically significant (p = 0.1). CONCLUSION With this study, it was concluded that, systemic isotretion leads to a 36% decline in skin sebum values and a 79% increase in the skin hydration. However, the change in skin elasticity was not statistically significant. Furthermore, the changes in sebum and skin hydration did not lead to a change in skin elasticity.
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The effects of green tea on acne vulgaris: A systematic review and meta-analysis of randomized clinical trials.
Kim, S, Park, TH, Kim, WI, Park, S, Kim, JH, Cho, MK
Phytotherapy research : PTR. 2021;(1):374-383
Abstract
Green tea extract (GTE) has been studied for the treatment of acne based on its anti-inflammatory/antioxidant properties. This systematic review and meta-analysis aimed to examine the effects of GTE on acne. Electronic databases, including PubMed, Embase, and the Cochrane Library were systematically searched up to August 2019. The effect size of acne lesion counts is presented as mean differences and 95% confidence intervals (CIs). Five randomized-controlled studies were included in the meta-analysis (N; experimental = 125, control = 122). GTE significantly reduced the number of inflammatory lesions (-9.38; 95% CI: -14.13 to -4.63). In subgroup analysis, topical GTE application significantly reduced the inflammatory lesion counts (-11.39; 95% CI: -15.91 to -6.86) whereas oral GTE intake showed minimal effect (-1.40; 95% CI: -2.50 to -0.30). Although GTE did not significantly reduce the number of non-inflammatory lesions (-21.65; 95% CI: -47.52 to 4.22), when stratified by the route of admission, non-inflammatory acne lesions were significantly reduced by topical GTE application (-32.44; 95% CI: -39.27 to -25.62) but not with oral GTE administration (0.20; 95% CI: 0.00 to 0.40). This systematic review and meta-analysis suggest that topical GTE application is beneficial for the treatment of acne without causing significant adverse events while oral GTE intake has limited effects. Further high-quality clinical trials are warranted.
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Observation for clinical effect of acupuncture combined with conventional therapy in the treatment of acne vulgaris.
Kou, L, Yu, N, Ren, J, Yang, B, Tao, Y
Medicine. 2020;(18):e19764
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Abstract
INTRODUCTION Acne vulgaris is a chronic inflammatory disease of the sebaceous glands that occurs in adolescent men and women. In recent years, the incidence of acne has increased year by year, so it is of great significance to find a precise and effective treatment and further explore its possible mechanism of action. The purpose of this study will be to explore a treatment method that has both traditional Chinese medicine characteristics and significant effects, and provides a higher level of evidence for acupuncture for acne vulgaris. It also provides patients with more treatment options. METHODS/DESIGN The study will be a randomized controlled trial divided into 2 parallel groups. This pragmatic randomized controlled trial will recruit 66 patients who are diagnosed with acne vulgaris. 30-minutes acupuncture sessions will be provided to patients assigned to the intervention group. All participants will continue to receive conventional treatment. The selection of outcomes will be evaluated by the skin lesions score scale. DISCUSSION This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with acne vulgaris. TRIAL REGISTRATION NUMBER CTR2000030427.
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FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial.
Poinas, A, Lemoigne, M, Le Naour, S, Nguyen, JM, Schirr-Bonnans, S, Riche, VP, Vrignaud, F, Machet, L, Claudel, JP, Leccia, MT, et al
Trials. 2020;(1):571
Abstract
BACKGROUND Acne vulgaris has increased in women over the past 10 years; it currently affects 20-30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone's efficacy in order to establish it as an alternative to cyclines. METHODS Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months. DISCUSSION The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. TRIAL REGISTRATION ClinicalTrials.gov: NCT03334682. Registered on 7 November 2017.
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Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha-hydroxy acid) for acne.
Liu, H, Yu, H, Xia, J, Liu, L, Liu, GJ, Sang, H, Peinemann, F
The Cochrane database of systematic reviews. 2020;(5):CD011368
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Abstract
BACKGROUND Acne is an inflammatory disorder with a high global burden. It is common in adolescents and primarily affects sebaceous gland-rich areas. The clinical benefit of the topical acne treatments azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid is unclear. OBJECTIVES To assess the effects of topical treatments (azelaic acid, salicylic acid, nicotinamide, zinc, alpha-hydroxy acid, and sulphur) for acne. SEARCH METHODS We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers. SELECTION CRITERIA Clinical randomised controlled trials of the six topical treatments compared with other topical treatments, placebo, or no treatment in people with acne. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. Key outcomes included participants' global self-assessment of acne improvement (PGA), withdrawal for any reason, minor adverse events (assessed as total number of participants who experienced at least one minor adverse event), and quality of life. MAIN RESULTS We included 49 trials (3880 reported participants) set in clinics, hospitals, research centres, and university settings in Europe, Asia, and the USA. The vast majority of participants had mild to moderate acne, were aged between 12 to 30 years (range: 10 to 45 years), and were female. Treatment lasted over eight weeks in 59% of the studies. Study duration ranged from three months to three years. We assessed 26 studies as being at high risk of bias in at least one domain, but most domains were at low or unclear risk of bias. We grouped outcome assessment into short-term (less than or equal to 4 weeks), medium-term (from 5 to 8 weeks), and long-term treatment (more than 8 weeks). The following results were measured at the end of treatment, which was mainly long-term for the PGA outcome and mixed length (medium-term mainly) for minor adverse events. Azelaic acid In terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence). There may be little or no difference in PGA when comparing azelaic acid to clindamycin (RR 1.13, 95% CI 0.92 to 1.38; 1 study, 229 participants; low-quality evidence), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). Low-quality evidence indicates there may be no differences in rates of withdrawal for any reason when comparing azelaic acid with benzoyl peroxide (RR 0.88, 95% CI 0.60 to 1.29; 1 study, 351 participants), clindamycin (RR 1.30, 95% CI 0.48 to 3.56; 2 studies, 329 participants), or tretinoin (RR 0.66, 95% CI 0.29 to 1.47; 2 studies, 309 participants), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). In terms of total minor adverse events, we are uncertain if there is a difference between azelaic acid compared to adapalene (1 study; 55 participants) or benzoyl peroxide (1 study, 30 participants) (both very low-quality evidence). There may be no difference when comparing azelaic acid to clindamycin (RR 1.50, 95% CI 0.67 to 3.35; 1 study, 100 participants; low-quality evidence). Total minor adverse events were not reported in the comparison of azelaic acid versus tretinoin, but individual application site reactions were reported, such as scaling. Salicylic acid For PGA, there may be little or no difference between salicylic acid and tretinoin (RR 1.00, 95% CI 0.92 to 1.09; 1 study, 46 participants; low-quality evidence); we are not certain whether there is a difference between salicylic acid and pyruvic acid (1 study, 86 participants; very low-quality evidence); and PGA was not measured in the comparison of salicylic acid versus benzoyl peroxide. There may be no difference between groups in withdrawals when comparing salicylic acid and pyruvic acid (RR 0.89, 95% CI 0.53 to 1.50; 1 study, 86 participants); when salicylic acid was compared to tretinoin, neither group had withdrawals (both based on low-quality evidence (2 studies, 74 participants)). We are uncertain whether there is a difference in withdrawals between salicylic acid and benzoyl peroxide (1 study, 41 participants; very low-quality evidence). For total minor adverse events, we are uncertain if there is any difference between salicylic acid and benzoyl peroxide (1 study, 41 participants) or tretinoin (2 studies, 74 participants) (both very low-quality evidence). This outcome was not reported for salicylic acid versus pyruvic acid, but individual application site reactions were reported, such as scaling and redness. Nicotinamide Four studies evaluated nicotinamide against clindamycin or erythromycin, but none measured PGA. Low-quality evidence showed there may be no difference in withdrawals between nicotinamide and clindamycin (RR 1.12, 95% CI 0.49 to 2.60; 3 studies, 216 participants) or erythromycin (RR 1.40, 95% CI 0.46 to 4.22; 1 study, 158 participants), or in total minor adverse events between nicotinamide and clindamycin (RR 1.20, 95% CI 0.73 to 1.99; 3 studies, 216 participants; low-quality evidence). Total minor adverse events were not reported in the nicotinamide versus erythromycin comparison. Alpha-hydroxy (fruit) acid There may be no difference in PGA when comparing glycolic acid peel to salicylic-mandelic acid peel (RR 1.06, 95% CI 0.88 to 1.26; 1 study, 40 participants; low-quality evidence), and we are uncertain if there is a difference in total minor adverse events due to very low-quality evidence (1 study, 44 participants). Neither group had withdrawals (2 studies, 84 participants; low-quality evidence). AUTHORS' CONCLUSIONS Compared to benzoyl peroxide, azelaic acid probably leads to a worse treatment response, measured using PGA. When compared to tretinoin, azelaic acid probably makes little or no difference to treatment response. For other comparisons and outcomes the quality of evidence was low or very low. Risk of bias and imprecision limit our confidence in the evidence. We encourage the comparison of more methodologically robust head-to-head trials against commonly used active drugs.
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Promising plant-derived secondary metabolites for treatment of acne vulgaris: a mechanistic review.
Soleymani, S, Farzaei, MH, Zargaran, A, Niknam, S, Rahimi, R
Archives of dermatological research. 2020;(1):5-23
Abstract
Acne vulgaris is the most common skin condition associated with inflammation of pilosebaceous unit. Since conventional therapies have not demonstrated desirable effectiveness and possess remarkable side effects, there is a growing interest in the use of herbal medicines for the management of acne vulgaris. In this study, plant-derived molecules investigated in acne vulgaris have been reviewed and their possible underlying mechanisms of action were discussed. For this purpose, different electronic databases including PubMed, Scopus, Cochrane library and Google Scholar were searched to obtain any in vitro, in vivo, or human studies evaluating the phytochemicals in the management of acne vulgaris. Data were collected from 1980 to 2018 (up to October). Most of the phytochemicals investigated in acne were from the category of polyphenols including resveratrol, myricitrin, schisandrin, terchebulin, alpha-mangotin, curcumin, ellagic acid and epigallocatechin 3-gallate. Moreover, alkaloids and terpenoids such as berberine, ursolic acid, lupeol were evaluated in acne vulgaris with less abundance. Various molecular mechanisms were involved in effects of phytochemicals including antioxidant (through down-regulation of H2O2, MDA, ROS and upregulation of SOD), anti-inflammatory (through reduction of proinflammatory cytokines, i.e., IL-1ß, IL-6, IL-8, TGF-β, TNF-α, NF-κB), immunomodulatory, antibacterial (against Propionibacterium acnes and Propionibacterium granulosum), antiandrogenic, reducing sebum production, and lipogenesis inhibitory activities. Therefore, phytochemicals seem to be a precious source for identifying new medicines for treatment of acne vulgaris; however, since most of studies are preclinical, further clinical studies are needed to achieve more conclusive and reliable results.
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Acne related to dietary supplements.
Zamil, DH, Perez-Sanchez, A, Katta, R
Dermatology online journal. 2020;(8)
Abstract
Multiple prescription medications may cause or aggravate acne. A number of dietary supplements have also been linked to acne, including those containing vitamins B6/B12, iodine, and whey, as well as "muscle building supplements" that may be contaminated with anabolic-androgenic steroids (AAS). Acne linked to dietary supplements generally resolves following supplement discontinuation. Lesions associated with high-dose vitamin B6 and B12 supplements have been described as monomorphic and although pathogenesis is unknown, a number of hypotheses have been proposed. Iodine-related acne may be related to the use of kelp supplements and has been reported as monomorphic, inflammatory pustules on the face and upper trunk. Whey protein supplements, derived from milk and used for bodybuilding, are associated with papulonodular acne involving the trunk and sometimes the face. Finally, AAS-induced acne has been described as acne fulminans, acne conglobata, and acne papulopustulosa. With studies indicating that about half of US adults report using dietary supplements, it is important that dermatologists directly ask acne patients about their supplement use and educate them on the potential risks of even seemingly innocuous dietary supplements.
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Evidence-based topical treatments (azelaic acid, salicylic acid, nicotinamide, sulfur, zinc, and fruit acid) for acne: an abridged version of a Cochrane systematic review.
Liu, H, Yu, H, Xia, J, Liu, L, Liu, G, Sang, H, Peinemann, F
Journal of evidence-based medicine. 2020;(4):275-283
Abstract
OBJECTIVE The effects of topical azelaic acid, salicylic acid, nicotinamide, sulfur, zinc, and fruit acid (alpha-hydroxy acid) for acne are unclear. We aimed to assess the effects of these topical treatments by collecting randomized controlled trials. METHODS We searched The Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS up to May 2019. We also searched five trials registers. Two review authors independently extracted data and assessed risk of bias. Meta analyses were performed by using Review Manager 5 software. RESULTS We included a total of 49 trials involving 3880 participants. In terms of treatment response (measured using participants' global self-assessment of acne improvement, PGA), azelaic acid was probably less effective than benzoyl peroxide (RR = 0.82, 95% CI 0.72-0.95). However, there was probably little or no difference in PGA when comparing azelaic acid to tretinoin (RR = 0.94, 95% CI 0.78-1.14). There may be little or no difference when comparing salicylic acid to tretinoin (RR = 1.00, 95% CI 0.92-1.09). There were no studies measured PGA when evaluating nicotinamide. With respect to alpha-hydroxy acid, there may be no difference in PGA when comparing glycolic acid to salicylic-mandelic acid (RR = 1.06, 95% CI 0.88-1.26). We were uncertain about the effects of sulfur and zinc. Adverse events associated with these topical treatments were always mild and transient. CONCLUSIONS Moderate-quality evidence was available for azelaic acid and low- to very-low-quality evidence for other topical treatments. Risk of bias and imprecision limit our confidence in the evidence.
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Selective RAR agonists for acne vulgaris: A narrative review.
Kassir, M, Karagaiah, P, Sonthalia, S, Katsambas, A, Galadari, H, Gupta, M, Lotti, T, Wollina, U, Abdelmaksoud, A, Grabbe, S, et al
Journal of cosmetic dermatology. 2020;(6):1278-1283
Abstract
BACKGROUND Acne vulgaris is a chronic disfiguring inflammatory disease of adolescents and adults affecting up to 90% of the population around the world. The sequence of etiopathogenesis in acne is not completely understood but involves abnormalities in sebum production, follicular plugging, proliferation of propionibacterium acnes, and chronic inflammation. AIMS This review aims to summarize the features of the topical selective RAR agonists in treating acne vulgaris with a special emphasis on the 4th generation topical retinoid trifarotene. METHODS Studies were identified by searching electronic databases (MEDLINE and PubMed) till August 2019 and reference lists of respective articles. Only articles published in English language were included. RESULTS Topical retinoids have been first line of treatment for more than 30 years now in treating mild to moderate acne vulgaris. Third generation retinoids like adapalene and tazarotene are selective RAR and γ agonists, having an additional anti-inflammatory action along with their comedolytic effects and work well in combinations with topical antibiotics, due to the stability of chemical composition. CONCLUSION Trifarotene is a new 4th generation retinoid with selective action on RAR-γ receptor alone, which is specific for skin, and it is safe for long-term maintenance therapy with good efficacy and tolerability.