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1.
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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2.
The safety and efficacy of four different fixed combination regimens of adapalene 0.1%/benzoyl peroxide 2.5% gel for the treatment of acne vulgaris: results from a randomised controlled study.
Tan, J, Bissonnette, R, Gratton, D, Kerrouche, N, Canosa, JM
European journal of dermatology : EJD. 2018;(4):502-508
Abstract
BACKGROUND Combined use of a retinoid and antimicrobial is recommended for acne, however, local tolerability issues may compromise patient adherence and treatment outcome. OBJECTIVES This multicentre, single-blinded controlled study was designed to determine whether modified adapalene/benzoyl peroxide (A/BPO, Epiduo®, Galderma, France) regimens improve local tolerability during the first four weeks of treatment without impairing efficacy at Week 12. MATERIALS & METHODS In total, 120 subjects with mild-to-moderate acne received, during the first four weeks, A/BPO daily overnight (A/BPO-EN), A/BPO daily for three hours (A/BPO-3h), A/BPO daily overnight and a provided moisturizer lotion (A/BPO-moisturizer), or A/BPO every other night (A/BPO-EoN). Local tolerance assessments included signs and symptoms, global worst score (GWS), and total sum score (TSS). Efficacy was assessed based on lesion counts, investigator global assessment (IGA), and total lesion count reduction. Adherence, subject satisfaction, and overall safety were also assessed. RESULTS The mean TSS was significantly reduced at Week 1 with A/BPO-EoN vs. A/BPO-EN (p<0.05), and A/BPO-EoN led to the lowest GWS and a decrease in severity of stinging/burning and erythema (p<0.05). The A/BPO-moisturizer regimen prevented dryness and scaling compared with the A/BPO-EN regimen. The median decrease in lesions from baseline was similar in all groups: up to 67% for total, 72% for inflammatory, and 70% for non-inflammatory lesion counts. Adherence, IGA, patient satisfaction, and overall safety were excellent. CONCLUSIONS Modulating treatment regimens during the first four weeks improved local tolerability without impacting overall efficacy outcome after 12 weeks and may improve treatment adherence during the first weeks of therapy.
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3.
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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4.
Combination therapy with adapalene-benzoyl peroxide and oral lymecycline in the treatment of moderate to severe acne vulgaris: a multicentre, randomized, double-blind controlled study.
Dréno, B, Kaufmann, R, Talarico, S, Torres Lozada, V, Rodríguez-Castellanos, MA, Gómez-Flores, M, De Maubeuge, J, Berg, M, Foley, P, Sysa-Jedrzejowska, A, et al
The British journal of dermatology. 2011;(2):383-90
Abstract
BACKGROUND Oral antibiotics in association with a topical retinoid with or without benzoyl peroxide (BPO) are the recommended first-line option in the treatment of moderate to severe acne vulgaris. OBJECTIVES To evaluate the efficacy and safety of oral lymecycline 300 mg with adapalene 0·1%-BPO 2·5% (A/BPO) fixed-dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne vulgaris. METHODS A total of 378 subjects were randomized in a double-blind, controlled trial to receive once-daily lymecycline with either A/BPO or vehicle for 12 weeks. Evaluations included percentage changes from baseline in lesion counts, success rate (subjects 'clear' or 'almost clear'), skin tolerability, adverse events and patients' satisfaction. RESULTS The median percentage reduction from baseline in total lesion counts at week 12 was significantly higher (P < 0·001) in the lymecycline with A/BPO group (-74·1%) than in the lymecycline with vehicle group (-56·8%). The success rate was significantly higher (47·6% vs. 33·7%, P = 0·002) in subjects treated with lymecycline and A/BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P < 0·001) with a rapid onset of action from week 2 for noninflammatory lesions (P < 0·001) and week 4 for inflammatory lesions (P = 0·005). The A/BPO and lymecycline combination was well tolerated. The proportion of satisfied and very satisfied subjects was similar in both groups, but the number in the A/BPO group who were 'very satisfied' was significantly greater (P = 0·031). CONCLUSION These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris.
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Comparison of micronized tretinoin gel 0.05% and tretinoin gel microsphere 0.1% in young adolescents with acne: a post hoc analysis of efficacy and tolerability data.
Lucky, AW, Sugarman, J
Cutis. 2011;(6):305-10
Abstract
Acne vulgaris is common in young adolescents. Retinoids are widely used but may be associated with poor tolerability. This post hoc analysis of 483 participants aged 10 to 14 years with mild to moderate acne compared efficacy and tolerability of once-daily treatment with micronized tretinoin gel 0.05%, tretinoin gel microsphere 0.1%, and vehicle over 12 weeks. In study 1, inflammatory and noninflammatory lesion reduction and treatment success was comparable between tretinoin gel 0.05% and tretinoin gel microsphere 0.1%. Inflammatory (46.3%) and noninflammatory (45.7%) lesion reductions with tretinoin gel 0.05% were significantly greater than vehicle (37.1% and 27.9%, respectively) (both P<.001). In study 2, inflammatory and noninflammatory lesion reductions and treatment success with tretinoin gel 0.05% (30.6%, 39.1%, and 19%, respectively) were significantly greater than vehicle (10.9%, 16.9% [both P<.001], and 4% [P=.008], respectively). Tretinoin gel 0.05% was significantly better tolerated than tretinoin gel microsphere 0.1% (P<.001); the majority of adverse events (AEs) were mild, occurring in the first 2 weeks. Fourteen percent of participants reported dry skin, 8% skin burning sensation, 5% erythema, and 5% dermatitis exfoliative with tretinoin gel 0.05% compared with 32%, 11%, 23%, and 23%, respectively, with tretinoin gel microsphere 0.1% (all P<.001, except skin burning sensation). In this secondary analysis of acne in young adolescents aged 10 to 14 years, micronized tretinoin gel 0.05% provided a comparable lesion reduction and treatment success versus tretinoin gel microsphere 0.1%, with a better cutaneous tolerability profile.
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Topical clindamycin 1% vs. linoleic acid-rich phosphatidylcholine and nicotinamide 4% in the treatment of acne: a multicentre-randomized trial.
Morganti, P, Berardesca, E, Guarneri, B, Guarneri, F, Fabrizi, G, Palombo, P, Palombo, M
International journal of cosmetic science. 2011;(5):467-76
Abstract
It has been shown that topical linoleic acid rich-phosphatidylcholine seems to be effective in normalization of follicular hyperkeratinization, whereas nicotinamide has an interesting anti-inflammatory effect. However, little is known about their combined effect on acne. A multicentre, double-blind, 12-week randomized vehicle and parallel-active control study was conducted by clinical and biophysical non-invasive measurements to evaluate the efficacy, tolerability and safety of a 4% nicotinamide-phospholipidic (N-PHCL) emulsion vs. 1% topical clindamycin phosphate applied once daily. Four percentage N-PHCL cosmetic treatment resulted slightly superior to topical clindamycin with all the parameters studied for its better compliance and the global clinical improvement.
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7.
A double-blind randomized controlled comparison of APDDR-0901, a novel cosmeceutical formulation, and 0.1% adapalene gel in the treatment of mild-to-moderate acne vulgaris.
Lee, HE, Ko, JY, Kim, YH, Yoo, SR, Moon, SH, Kim, NI, Park, CW, Kim, JH, Koh, HJ, Park, WS, et al
European journal of dermatology : EJD. 2011;(6):959-65
Abstract
Topical retinoids have been widely used in the treatment of acne. They comprise several products used as prescription drugs as well as cosmeceuticals. Of these products, retinol has better tolerability compared with prescription retinoids such as tretinoin, but it is only used in cosmeceuticals due to its low biologic activity. A combination formulation could be an effective alternative to address the problem of decreased therapeutic activity. Recently, hexamidine diisethionate is known to have antibacterial activity, and rose extract has been shown to possess anti-inflammatory activity. In this study, we compared the efficacy and safety of the combination product APDDR-0901 (0.03% retinol, 0.7% rose extract, and 0.05% hexamidine diisethionate) vs 0.1% adapalene gel for the treatment of mild-to-moderate acne. This 12-week, multicenter, double-blinded study included 97 patients with mild-to-moderate acne. Efficacy was evaluated using 4 discrete variables: lesion count, acne grade, physician-assessed global improvement, and patient self-assessment. We also assessed safety profiles, including cutaneous irritation. Both APDDR-0901 and adapalene showed significant improvements without significant differences. Otherwise, the APDDR-0901 group showed better safety profiles, particularly in the first 2 weeks. In conclusion, APDDR-0901 could be an effective and safe alternative in the treatment of mild-to-moderate acne.
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Clinical evidence for the role of a topical anti-inflammatory agent in comedonal acne: findings from a randomized study of dapsone gel 5% in combination with tazarotene cream 0.1% in patients with acne vulgaris.
Tanghetti, E, Dhawan, S, Green, L, Ling, M, Downie, J, Germain, MA, Kasteler, JS, Kircik, L, Oefelein, MG, Draelos, Z
Journal of drugs in dermatology : JDD. 2011;(7):783-92
Abstract
BACKGROUND Acne pathogenesis is multifactorial and includes inflammation. Combining drugs targeting multiple components of acne pathogenesis is standard practice. OBJECTIVE To assess the safety and efficacy of dapsone gel 5%, an anti-inflammatory agent, in combination with tazarotene cream 0.1% for treatment of acne vulgaris. METHODS Patients were randomized to receive combination therapy (dapsone gel 5% twice-daily plus tazarotene cream 0.1% daily) or monotherapy (tazarotene cream 0.1% daily). Efficacy and safety data were collected after 1, 2, 4, 8, and 12 weeks of treatment. RESULTS Patients in both arms (n=86, dapsone + tazarotene; n=85, tazarotene) showed significant reductions from baseline in inflammatory, noninflammatory and total lesion counts (P is less than .001 for all). At 12 weeks, patients treated with dapsone plus tazarotene showed a greater reduction from baseline in noninflammatory (comedonal) and total lesion counts than tazarotene-treated patients (noninflammatory, 59.7 percent vs. 46.5 percent, P=.01; total, 63.3% vs. 53.6%, P=.02). The percentage of patients achieving treatment success (an investigator subjective score of 0 [none] or 1 [minimal]) was greater in dapsone plus tazarotene?treated patients (42.2%) than in tazarotene-treated patients (21.8%;P=.01). Both treatments were well tolerated. CONCLUSION Combination therapy with dapsone gel 5% plus tazarotene cream 0.1% was more effective than tazarotene monotherapy for treatment of comedonal acne. The results suggest that anti-inflammatory agents such as dapsone can effectively treat early stages of acne (both comedonal and noncomedonal) when used in combination with a retinoid.
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Treatment of mild-to-moderate acne vulgaris using a combined light and heat energy device: home-use clinical study.
Sadick, NS, Laver, Z, Laver, L
Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology. 2010;(6):276-83
Abstract
INTRODUCTION Light and heat devices have become widely used for the treatment of mild-to-moderate inflammatory acne as an alternative to retinoids and antibiotics. The purpose of this study was to examine whether a hand-held device that emits both light and heat energy can safely and effectively be applied at home to shorten the time to improvement and time to resolution of acne papules and pustules. METHODS A two-center, randomized, placebo-controlled, double-blind study was conducted on 63 subjects with at least four inflamed, facial, acne lesions. Treatments were self-administered twice a day for 4 days. All lesions were photographed on a daily basis. Treatment results were assessed by two blinded evaluators, based on the macro photographs, using a 4-point visual analogue scale (VAS) and a photographic lesion reference scale (PLRS), as well as by the subjects. Safety was assessed based on evaluators and subjects' reported side effects and adverse events. RESULTS Twenty-nine subjects in the treatment arm and 32 subjects in the placebo arm, with skin types II-VI, successfully completed the study. Based on blinded VAS scores, 92.24% of the lesions treated with an active device improved within a median time of 1 day versus 75.78% and a median time of 2 days for the placebo arm. At 24 hours the improvement rate was 76.72% for the active arm versus 15.63% for the placebo arm. Based on blinded PLRS scores, 87.07% of the lesions treated with an active device improved within a median time of 2 days versus 64.8% and 3 days for the placebo. A total of 51.7% of the active arm lesions resolved within a median time of 4 days versus 36% (no median) for the placebo arm lesions. No device-related adverse events occurred throughout the study. CONCLUSION This study demonstrates the safety and effectiveness of the hand-held, combined light and heat energy device for at-home treatment of individual mild-to-moderate inflammatory acne lesions. Statistically significant shorter lesion improvement and lesion resolution rates were found.
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10.
Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris.
Zouboulis, CC, Fischer, TC, Wohlrab, J, Barnard, J, Alió, AB
Cutis. 2009;(4):223-9
Abstract
This study investigated the efficacy, tolerability, and safety of 2 fixed-dose combination gels for the treatment of facial acne: clindamycin 1%-benzoyl peroxide 5% gel with hydrating excipients (C/BPO HE) and adapalene 0.1%-benzoyl peroxide 25% gel (A/BPO). After 12 weeks of once daily treatment, the mean reduction in inflammatory lesion count was 76.8% and 72.2% in the C/BPO HE group and A/BPO group, respectively (P = .076). Significantly more participants achieved treatment success, which was defined as an improvement of 2 grades or more from baseline to week 12 on the investigator's static global assessment (ISGA) scale, with C/BPO HE (30.5% [58/190]) compared with A/BPO (21.8% [42/192]) (P = .046), and treatment success was achieved more quickly with C/BPO HE (P = .035). Both products also reduced noninflammatory (62.2% C/BPO HE vs 6 1.5% A/BPO) and total lesion counts (69.1% C/BPO HE vs 67.1% A/BPO). Despite the overall similar efficacy profile, C/BPO HE was better tolerated and safer than A/BPO. In the tolerability assessments, erythema, dryness, peeling, pruritus, and burning/ stinging were more frequent in the A/BPO group at all time points from week 1 onward (P < .05). Treatment-related adverse events (AEs) occurred in 48.4% (92/190) of participants in the C/BPO HE group compared with 78.6% (151/192) of the A/BPO group. We conclude that C/BPO HE and A/BPO have similar efficacy in treating inflammatory and noninflammatory acne lesions, but C/BPO HE achieves better overall treatment success in less time coupled with a significantly better tolerability profile and notably better safety profile.