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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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Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: A double-blind, randomized placebo-controlled trial.
Chottawornsak, N, Chongpison, Y, Asawanonda, P, Kumtornrut, C
The Journal of dermatology. 2019;(12):1184-1189
Abstract
The emergence of bacterial resistance is a global crisis. Prolonged use of antibiotics especially in acne is one issue of concern among dermatologists. Ketoconazole (KTZ) cream, a topical antifungal with anti-inflammatory and antiandrogenic actions, can decrease lipase activity of Cutibacterium acnes in vitro. We evaluated the efficacy and safety of KTZ cream in mild adult female acne (AFA) by conducting a randomized, double-blind, placebo-controlled trial using KTZ 2% and placebo cream twice daily for 10 weeks. We assessed the improvement of clinical severity, measured by AFA score graded by investigators and participants, and the change of acne count. Forty-one participants enrolled in our study. The proportion of participants with acne improvement from baseline (42.9% vs 9.5%, P = 0.015) and the success rate (45.0% vs 14.3%, P = 0.043) in the KTZ group were significantly higher than that of the placebo group. The most common adverse events were dryness and itching. The percentage change of acne count decreased significantly compared with baseline but did not differ statistically between the two groups (P = 0.268). We concluded that the KTZ monotherapy showed a plausible effect in improving AFA with excellent safety profile. It should be considered as a viable option for mild AFA treatment.
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Efficacy and safety of 2% supramolecular salicylic acid compared with 5% benzoyl peroxide/0.1% adapalene in the acne treatment: a randomized, split-face, open-label, single-center study.
Zheng, Y, Yin, S, Xia, Y, Chen, J, Ye, C, Zeng, Q, Lai, W
Cutaneous and ocular toxicology. 2019;(1):48-54
Abstract
BACKGROUND Topical drugs for mild to moderate acne include adapalene (ADA) and benzoyl peroxide(BPO). Supramolecular salicylic acid (SSA), a modified SA preparation, is considered as a new effective therapeutic scheme. OBJECTIVES To compare the safety and efficacy of 2% supramolecular SA (2% SSA) with 0.01% adapalene plus 5% benzoyl peroxide (5%BPO +0.1%ADA) for treatment of facial acne. MATERIALS AND METHODS This was an open-label, split face, randomized and single-centre clinical trial. Subjects with mild to moderate acne were enrolled. Two percent SSA cream were randomly applied on one side of the face while 5%BPO +0.1%ADA gel was applied on the opposite side for 28 days. The numbers of acne lesions, along with side effects of the targeted area were evaluated by the investigators at day 0, day 14, and day 28. Skin water content, TEWL and skin lightening indexes were measured at the same time. RESULTS A total of 31 of acne patients completed the trial. Dates showed that 2% SSA had similar effects to 5%BPO +0.1%ADA in reducing papules/pustules (47.9% vs. 49.8%), non-inflammatory lesions (43.1% vs. 42.7%) and total lesions (44.1% vs. 45.6%; all p > 0.05) at day 28. The skin barrier (skin hydration value and TEWL value), skin brightness (L* value) and erythema (a* values) indicators showed no statistical differences in the left and right sides of the face (p > 0.05). CONCLUSION This study demonstrated that 2% SSA has a similar efficacy with 5%BPO +0.1%ADA in mild to moderate acne treatment. This might be a useful pilot study that could be used to support further larger clinical trials.
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Efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese versus 0.02% triamcinolone acetonide cream in decreasing adverse reaction and downtime after ablative fractional carbon dioxide laser resurfacing: A split-face, double-blinded, randomized, controlled trial.
Lueangarun, S, Srituravanit, A, Tempark, T
Journal of cosmetic dermatology. 2019;(6):1751-1757
Abstract
INTRODUCTION Fractional carbon dioxide (FrCO2 ) laser is effective for atrophic acne scar treatment, but unavoidable downtime. Meanwhile, postoperative topical steroid decreases the downtime, yet still possibly increases other steroid side effects. OBJECTIVE To evaluate the efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese (experimental cream) versus 0.02% Triamcinolone acetonide (TA) cream in decreasing adverse effects and downtime after FrCO2 laser, with wound healing improvement and prevention of certain steroid-related side effects like postinflammatory hyperpigmentation (PIH). METHODS We conducted a double-blinded, split face, randomized controlled trial in 20 subjects receiving FrCO2 laser on both sides of the faces and randomly treated with two posttreatment regimens on each side for 7 days. Clinical, expert panel assessment of photography, downtime, side effects, and biometric evaluation for erythema and melanin were performed on baseline, immediately after treatment, day 3, 5, 7, 14, 30 and, 60 postoperatively. RESULTS Both experimental cream (EC) and 0.02% TA cream could significantly reduce postlaser downtime including swelling, redness, crusting, and scaling in 5-7 days, with comparable efficacies in decreasing downtime and adverse reactions, as well as wound healing improvement and lower PIH without statistically significant difference between the two treatments. The incidence of PIH was 60% in the EC treated group with minimal intensity. CONCLUSION The moisturizer with anti-inflammatory ingredients could be a novel treatment modality for reduction of postablative laser downtime by using nonsteroidal anti-inflammatory agents to avoid adverse effects and improve wound healing process with lower PIH.
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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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Reducing the oral isotretinoin skin side effects: efficacy of 8% omega-ceramides, hydrophilic sugars, 5% niacinamide cream compound in acne patients.
Cannizzaro, MV, Dattola, A, Garofalo, V, Del Duca, E, Bianchi, L
Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia. 2018;(2):161-164
Abstract
BACKGROUND Acne vulgaris is a chronic inflammatory skin disease that manifests as open and closed comedones as well as inflammatory papules, pustules, and nodules localized on face and trunk. Oral isotretinoin demonstrated to be effective in controlling seborrhea, inflammation, Propionibacterium Acnes hyperproliferation and reducing scarring, nevertheless muco-cutaneous side effects, particularly dryness, itching, bruising are commonly seen in patients under treatment with isotretinoin reducing the compliance to the treatment. We conducted a randomized controlled trial to evaluate the efficacy of a cream compound formulated in order to reduce the oral isotretinoin side effects (redness, dryness, itching) in patients affected by severe acne of the face. METHODS Twenty-seven patients undergoing treatment with 0.5-1 mg/kg/day for papulo-pustular or nodulo-cystic acne were randomized to additionally receive a cream composed of 8% omega-ceramides, hydrophilic sugars, 5% niacinamide applied twice daily (group A) or placebo cream (group B) applied 2 times per day. RESULTS During the whole treatment period and after 6 months of treatment, patients in the group A showed a greater reduction of dryness, itching and redness compared to the group receiving the placebo cream. CONCLUSIONS The cream formulated with 8% omega-ceramides, hydrophilic sugars, 5% niacinamide was effective in reducing xerosis and skin irritation, and was also successful in improving the patients' adherence to the oral isotretinoin treatment.
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Tretinoin Loaded Nanoemulsion for Acne Vulgaris: Fabrication, Physicochemical and Clinical Efficacy Assessments.
Sabouri, M, Samadi, A, Ahmad Nasrollahi, S, Farboud, ES, Mirrahimi, B, Hassanzadeh, H, Nassiri Kashani, M, Dinarvand, R, Firooz, A
Skin pharmacology and physiology. 2018;(6):316-323
Abstract
BACKGROUND AND AIM Acne vulgaris is a common inflammatory skin condition which is treated using Tretinoin (TRE), a widely used retinoid. Nano emulations (NEs) are colloidal nano-sized particles that enhance the therapeutic efficacy of TRE and minimize adverse effects. This study is aimed at developing a TRE-loaded NE (NE-TRE) and at assessing the therapeutic effects of the formulation in acne vulgaris lesions, compared to conventional 0.05% TRE emulsion. METHOD The high energy emulsification method was used to make NE-TRE. After obtaining stable NE, particle characterization and physicochemical properties were evaluated under accelerated conditions. Conducting a clinical study, we compared the therapeutic effects of NE-TRE and 0.05% TRE emulsion by comparing the number of acne lesions and porphyrin production in both sides of the face. RESULTS AND CONCLUSION We successfully developed stable nanoparticles. It was a stable oil-in-water emulsion with particle size of about 150 nm, and containing circular and separated particles. In a pilot clinical study, the number of acne lesions as well as the size and intensity of porphyrin production significantly reduced after topical application of NE-TRE. This formula shows proper efficiency and good loading capacity of TRE in the drug delivery system.
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A randomized, split-face, controlled, double-blind, single-centre clinical study: transient addition of a topical corticosteroid to a topical retinoid in patients with acne to reduce initial irritation.
Coman, GC, Holliday, AC, Mazloom, SE, Chavan, RN, Kolodney, MS
The British journal of dermatology. 2017;(2):567-569
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Fragility of epidermis: acne and post-procedure lesional skin.
Fabbrocini, G, Rossi, AB, Thouvenin, MD, Peraud, C, Mengeaud, V, Bacquey, A, Saint Aroman, M
Journal of the European Academy of Dermatology and Venereology : JEADV. 2017;:3-18
Abstract
'Fragile skin', or skin with lower resistance to aggressors, can be broadly classified into four causal categories: constitutional (age-dependent or associated with specific vulnerable locations on the body, e.g. eyelids), pathological (related to disease), circumstantial (related to environmental or internal factors, e.g. stress) and iatrogenic (caused by medical interventions or treatments). In this supplement, we focus on the fourth category, the iatrogenic origin of fragile skin and the role that dermo-cosmetics can have in restoring the natural protective function of the skin following treatments for skin diseases and medical interventions. We present epidemiological data on the prevalence of fragile skin in three different geographical regions, and the results of two randomized controlled studies investigating the efficacy and tolerability of dermo-cosmetics in combination with topical acne treatment and following physical skin damage. Overall, we found that prevalence across the three regions (23% in Germany, 41% in UAE, 56% in Taiwan) reflected previous global estimates (24-53%) across skin types, with significant associations found with environmental and lifestyle factors, such as stress, humidity and pollution. The iatrogenic effects of topical acne treatments can result in poor compliance or use of over-the-counter moisturizers, which may reduce treatment efficacy. Dermo-cosmetics were found to aid in restoration of fragile skin caused by the acne topical retinoid treatment adapalene 0.1% gel, by reducing transepidermal water loss and improving skin hydration, as well as reducing the side-effects such as skin irritation that are frequently associated with topical retinoids. Additionally, dermo-cosmetic products were found to accelerate wound closure following skin damage in a laser ablation model and reduced the duration of post-procedural side-effects such as itching and burning.
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Efficacy and Safety of Tazarotene 0.1% Plus Clindamycin 1% Gel Versus Adapalene 0.1% Plus Clindamycin 1% Gel in Facial Acne Vulgaris: A Randomized, Controlled Clinical Trial.
Maiti, R, Sirka, CS, Ashique Rahman, MA, Srinivasan, A, Parida, S, Hota, D
Clinical drug investigation. 2017;(11):1083-1091
Abstract
BACKGROUND Acne vulgaris is a multifactorial disorder which is ideally treated with combination therapy with topical retinoids and antibiotics. OBJECTIVES The present study was conducted to compare the efficacy and safety of tazarotene plus clindamycin against adapalene plus clindamycin in facial acne vulgaris. METHODS This study is a randomized, open-label, parallel design clinical trial conducted on 60 patients with facial acne at the outpatient dermatology department in a tertiary healthcare center. The main outcome measures were change in the acne lesion count, Investigator's Static Global Assessment (ISGA) score, Global Acne Grading System (GAGS) score, and Acne-Specific Quality of Life Questionnaire (Acne-QoL) at the end of 4 weeks of therapy. After randomization one group (n = 30) received tazarotene 0.1% plus clindamycin 1% gel and another group (n = 30) received adapalene 0.1% plus clindamycin 1% gel for 1 month. At follow-up, all the parameter were reassessed. RESULT In both treatment regimens the total number of facial acne lesions decreased significantly. The difference in the change in the total count between the two combination regimens was also significant [6.51, 95% confidence interval (CI) 1.91-11.09, p = 0.007]. A ≥50% reduction in the total lesion count from the baseline levels was achieved by 71% of patients in the tazarotene plus clindamycin group and 22% of patients in the adapalene plus clindamycin group (p = 0.0012). The difference in the change of inflammatory (p = 0.017) and non-inflammatory (p = 0.039) lesion counts in the tazarotene plus clindamycin group were significantly higher than the adapalene plus clindamycin group. The difference in change of the GAGS score was also significantly higher in the tazarotene plus clindamycin group (p = 0.003). The ISGA score improved in 17 patients in the tazarotene plus clindamycin group versusnine patients in the adapalene plus clindamycin group (p = 0.04). The change of total quality-of-life score was found to be significantly (p = 0.027) higher in the tazarotene plus clindamycin group. CONCLUSIONS Both treatment regimens were efficacious, but tazarotene plus clindamycin was found to be superior to adapalene plus clindamycin. The tolerability profile of both regimens was comparable. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02721173.