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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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Clinical assessment of topical erythromycin gel with and without zinc acetate for treating mild-to-moderate acne vulgaris.
Sayyafan, MS, Ramzi, M, Salmanpour, R
The Journal of dermatological treatment. 2020;(7):730-733
Abstract
Purpose: Erythromycin is an effective topical antibiotic for treating mild-to-moderate inflammatory acne vulgaris, especially papules acne during puberty as well as papules - pustular acne in adult women. Erythromycin is a macrolide antibiotic that has long been used as a topical dosage form to treat acne. It has favorable effects in resolving inflammatory acne lesions not only by reducing Propioni bacterium acnes density, but also by directly inhibiting neutrophil chemotactic factors and reactive oxygen species (ROS) production. Zinc, a metallic element has bacteriostatic activity against Propioni bacterium acnes. Combining zinc with antibiotic (erythromycin) can reduce antibiotic resistance and increase antibiotic absorption in-to the skin.Material and methods: In the present study, erythromycin (2% w/v) with zinc acetate (1.2% w/v) as 'topical gel' and erythromycin (2% w/v) gel alone were evaluated for treating mild to moderate inflammatory acne vulgaris. This double-blind study was carried out on 102 patients 13-25 years of age, divided into two groups. The group A received erythromycin and group B received erythromycin with zinc acetate topical gels during 3 weeks. Acne grading and lesion counts for comedones, papules and pustules were performed during each visit zero, first, second and third weeks.Results: Erythromycin treatment (with zinc acetate) gel showed to be more effective than erythromycin (alone) gel with respect to reducing the number of acne lesions and severity grade of acne.Number of lesions and severity of acne were significantly reduced at the end of 3rd week in both groups (p < .001). Conclusions: In conclusion, it can be stated that erythromycin with and without zinc acetate was clinically effective, and both formulations produced a significant reductions in acne grading as well as inflamed and noninflamed lesion counts (p < .000). Statistically, there was no significant difference between formulation A and B.
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An Advanced, Physician-Strength Retinol Peel Improves Signs of Aging and Acne Across a Range of Skin Types Including Melasma and Skin of Color.
Sadick, N, Edison, BL, John, G, Bohnert, KL, Green, B
Journal of drugs in dermatology : JDD. 2019;(9):918-923
Abstract
Background: Facial chemical peels are highly sought after by patients with photodamage, acne, and melasma. An advanced, physician-strength superficial peel, containing 3% retinol with other firming and volumizing ingredients was developed to exfoliate, improve the appearance of fine lines and wrinkles, and plump and firm skin, while promoting a bright, even complexion. Objective: A clinical study was conducted to evaluate the tolerability, safety, and efficacy of the 3% retinol peel with a supportive homecare regimen across a range of peel candidates, females aged 18-65 years, with photodamage, acne, hyperpigmentation or melasma, and skin of color, over a series of 2-4 peels. Method: The 3% retinol peel formulation was administered under physician direction in 6-week intervals. Subjects with photodamaged skin, acne, hyperpigmentation/melasma, or skin of color (Fitzpatrick skin types IV-VI) received 2-4 peels along with a supportive homecare regimen. Dermatologist grading, self-assessment, and digital photography documented tolerability and efficacy parameters. Results: 24 subjects participated in the study with a total of 78 peels administered (Photodamage group, n=14 [with an Acne subgroup, n=5]; Melasma group, n=5; Skin of Color, n=5). The 3% retinol peel along with the homecare regimen was well tolerated under physician direction in all skin types and conditions assessed. Obvious peeling was noticeable in many subjects 3 days post-peel and resolved by day 7. In the photodamaged group, dermatologist clinical grading of fine lines, wrinkles, pore size, laxity, mottled pigmentation, lack of clarity/radiance, and overall photodamage was significantly improved (P<0.05). Benefits were observed in all groups and supported by self-assessment. Digital photography demonstrated tolerability in the days immediately post-peel, along with benefits to photodamage. Conclusion: The 3% retinol superficial peel was well tolerated and an efficacious cosmetic treatment under physician supervision in subjects of all skin types to firm skin, improve fine lines and wrinkles, and promote a bright, even complexion. J Drugs Dermatol. 2019;18(9):918-923.
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Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne.
Tan, J, Thiboutot, D, Popp, G, Gooderham, M, Lynde, C, Del Rosso, J, Weiss, J, Blume-Peytavi, U, Weglovska, J, Johnson, S, et al
Journal of the American Academy of Dermatology. 2019;(6):1691-1699
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Abstract
BACKGROUND Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. OBJECTIVES Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. METHODS Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. RESULTS In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle. LIMITATIONS Adjunctive topical or systemic treatments were not studied. CONCLUSION These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.
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The efficacy and tolerability of 5-aminolevulinic acid 5% thermosetting gel photodynamic therapy (PDT) in the treatment of mild-to-moderate acne vulgaris. A two-center, prospective assessor-blinded, proof-of-concept study.
Serini, SM, Cannizzaro, MV, Dattola, A, Garofalo, V, Del Duca, E, Ventura, A, Milani, M, Campione, E, Bianchi, L
Journal of cosmetic dermatology. 2019;(1):156-162
Abstract
BACKGROUND Acne vulgaris is a chronic inflammatory skin disease, commonly treated with topical or systemic drugs, according to the severity of the condition. Retinoids and antibiotic compounds are considered cornerstone approaches in this condition. However, low adherence to the therapy and the issue of bacterial resistance undermine the efficacy in the long term. Photodynamic therapy (PDT) with 20% aminolevulinic acid (ALA) has shown to be effective in the treatment of inflammatory acne. Skin tolerability, however, could be a limiting factor for a widespread use of this approach. A new formulation of 5% ALA in thermosetting gel has been recently available. This formulation allows a more convenient application procedure without occlusion and better and more efficient release of the active compound in comparison with traditional ALA formulations like creams or ointments. STUDY AIM To evaluate in a two-center, assessor-blinded, prospective, proof-of-concept study, the efficacy, and tolerability of red-light (630 nm) PDT with a new 5-ALA "low-dose" topical gel formulation (5%) in the treatment of inflammatory mild-to-moderate acne vulgaris (AV). SUBJECTS AND METHODS A total of 35 subjects with moderate AV of the face (mean age: 24 ± 8 years, 13 men and 22 women) were enrolled, after their written informed consent. The primary outcome was the evolution of GAG (Global Acne Grade System) score at baseline and after an average of three, 630-nm, 15-minute, PDT sessions, performed every 2 weeks. GAG score was also calculated in a follow-up visit 6 months after the last PDT session. Skin tolerability was assessed during PDT sessions with a patient-reported discomfort level evaluation score from 0 (no discomfort at all) to 3 (severe discomfort). RESULTS At baseline, the GAG score was 21 ± 6. After the last PDT session, the GAG score evaluated in a blinded fashion (digital photographs) was significantly reduced to 6.5 ± 5.7, representing a 70% reduction (P = .0001, Wilcoxon test; mean difference 14.9; 95% CI of the difference: 12.1-17.6). At the follow-up visit, the GAG score was 6.7 ± 6.8. The 5% ALA thermosetting gel Red-light PDT was in general very well tolerated with a discomfort mean level score of 0.5 ± 1. CONCLUSION This proof-of-concept study supports the efficacy of 5% ALA thermosetting gel red-light PDT in inflammatory acne of the face with a relevant clinical improvement of inflammatory lesions with a very good tolerability profile. Clinical improvement was maintained in the medium term (Trial Registration Number: ISRCTN66066651).
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Anti-acne properties of hydrophobic fraction of red ginseng (Panax ginseng C.A. Meyer) and its active components.
Hou, JH, Shin, H, Jang, KH, Park, CK, Koo, B, Shin, H, Yuk, SH, Lee, KY
Phytotherapy research : PTR. 2019;(3):584-590
Abstract
Acne is a chronic inflammatory disease of the skin that occurs when bacteria abnormally grow in hair follicles. The most common treatment is antibiotics, but they are limited due to antibiotic resistance. The purpose of this study was to identify the active ingredients of the antimicrobial effects of red ginseng (Panax ginseng C.A. Meyer), compare it to existing antibacterial substances, and determine its potential efficacy as a natural drug product. The hydrophobic fraction in red ginseng ethanol extract (RGEF) showed the same or better antimicrobial activity against Propionibacterium acnes than benzoyl peroxide or azelaic acid. In addition, the antimicrobial component derived from red ginseng selectively showed a high antimicrobial effect on P. acnes. Nuclear magnetic resonance spectroscopic analysis showed that the active antimicrobial substance in this fraction was panaxynol and panaxydol. Twenty subjects who had acne symptoms were treated with cream containing 3 mg/g of RGEF for 4 weeks. It was found that oxidized sebum contents and redness of the skin were reduced, and symptoms of the early to middle stage of acne were effectively improved. This study showed that red ginseng extract containing panaxynol and panaxydol can effectively control the symptoms of acne.
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Efficacy and tolerability of topical 0.2% Myrtacine® and 4% vitamin PP for prevention and treatment of retinoid dermatitis in patients with mild to moderate acne.
Veraldi, S, Giovene, GL, Guerriero, C, Bettoli, V
Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia. 2012;(5):491-7
Abstract
AIM: The aim of the present study was to evaluate the efficacy and tolerability of an emulsion of 0.2% Myrtacine® and 4% vitamin PP, compared with a simple emollient cream, in the treatment of retinoid dermatitis in patients with mild-to-moderate acne. METHODS This was a prospective, multicenter, open-label, non-randomised, parallel-group study. Patients (age 12-49 years; skin phototype I-IV) with mild-to-moderate acne, who were treated with a topical retinoid for at least one month and had developed skin irritation were assigned to one of the two following treatments: 0.2% Myrtacine® and 4% vitamin PP (N.=116) or a simple emollient cream (N.=48). Both treatments were administered twice daily, 1-1.5 hours after the application of the topical retinoid. Study endpoints were improvement in signs and symptoms of retinoid dermatitis, global efficacy, reduction in acne severity, overall clinical outcome, patient satisfaction and tolerability. RESULTS At day 28, compared with the simple emollient cream, 0.2% Myrtacine® and 4% vitamin PP significantly decreased signs (erythema, dryness/scaling, oedema, and roughness) and symptoms (itching, stinging, burning sensation and discomfort) of retinoid dermatitis (P<0.01). In addition, compared with the simple emollient cream, 0.2% Myrtacine® and 4% vitamin PP decreased acne severity in a significantly greater proportion of patients (P=0.023) and was associated with a better clinical outcome (mild, intermediate, clinically relevant or global improvement; P<0.001). 0.2% Myrtacine® and 4% vitamin PP was also associated with greater patient satisfaction and was better tolerated than the simple emollient cream. CONCLUSION 0.2% Myrtacine® and 4% vitamin PP was effective and well tolerated in the treatment of retinoid dermatitis in patients with mild-to-moderate acne and significantly improved acne severity and overall clinical outcome.
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Effect of isotretinoin treatment on plasma holotranscobalamin, vitamin B12, folic acid, and homocysteine levels: non-controlled study.
Karadag, AS, Tutal, E, Ertugrul, DT, Akin, KO
International journal of dermatology. 2011;(12):1564-9
Abstract
Isotretinoin (Iso) has been used for the treatment of acne. Some previous studies reported elevated homocysteine (Hcy) levels after treatment with Iso. Some side effects have clinical presentations similar to vitamin B12, folic acid deficiencies, and hyperhomocysteinemia. In the present study we evaluated the plasma Hcy levels, the vitamins involved in its metabolism (vitamin B12 and folic acid), and holotranscobalamin (HoloTC), a transport system for vitamin B12 absorption in patients receiving Iso treatment for acne vulgaris. A total of 66 patients with acne vulgaris between the ages of 18 and 40 years were included. Screening for hemoglobin, creatinine, SGOT, SGPT, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and very low-density lipoprotein cholesterol (VLDL-C), folic acid, vitamin B12, Hcy, and HoloTC were done just before initiation (pretreatment) and after four months of Iso treatment (posttreatment). Posttreatment vitamin B12, folic acid, and HoloTC levels were significantly lower while Hcy levels were significantly higher compared with initial values. Posttreatment total cholesterol, LDL-C, triglycerides, VLDL-C, SGPT, and SGOT levels were also higher, and HDL-C levels were lower compared with initial values while there was no change in hemoglobin levels during Iso treatment. We found that Iso usage might cause decreased vitamin B12, folic acid, and HoloTC. These Iso side effects might contribute to the missing link between Iso usage, hyperhomocysteinemia, and neuropsychiatric disorders. Trials may be made with the aim of demonstrating (clearly) if starting vitamin B12 and folic acid replacement therapies with Iso treatment initialization could be useful for preventing hyperhomocysteinemia and possibly related disorders.
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Influence of isotretinoin on nasal mucociliary clearance and lung function in patients with acne vulgaris.
Gorpelioglu, C, Ozol, D, Sarifakioglu, E
International journal of dermatology. 2010;(1):87-90
Abstract
Retinoids are widely used to treat acne in patients with underlying systemic diseases. We evaluated the effect of 13-cis-retinoic acid (isotretinoin) on nasal mucociliary clearance and pulmonary function tests (PFTs) in patients with severe acne vulgaris. Each side effect was scored using a 4-point scale. Mucociliary clearance was evaluated by the saccharin test (ST). ST and PFTs were performed on all patients before and during the third month of treatment. A total of 40 acne patients (88% female, mean age 25 +/- 7 years) were included. The most common side effects were dryness, chapped lips, and xerosis. Mild epistaxis occurred in 13 patients; only two patients reported bleeding more than 10cc. There was no difference before and during the third month of treatment in forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), FEV1/FVC ratio, forced expiratory flow rate between 25% and 75% of FVC (FEF(25-75)), and their predicted percentage ratios. Mean nasal mucociliary clearance time was 12.6 +/- 4.1 min before and 15.9 +/- 5.7 after treatment (P < 0.001). We found that nasal clearance was significantly prolonged with treatment, and there was significant correlation between drug dose and mucociliary clearance time. Isotretinoin caused signs and symptoms of dry nose and disturbed mucociliary clearance without affecting PFTs. Nasal complications generally are not serious, especially when isotretinoin is taken in low doses.