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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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Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials.
Tanghetti, EA, Werschler, WP, Lain, T, Guenin, E, Martin, G, Pillai, R
Journal of drugs in dermatology : JDD. 2020;(1):70-77
Abstract
BACKGROUND Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids. Irritation from the cream, foam, and gel formulations has limited its use in clinical practice. OBJECTIVE To assess the efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion formulation based on polymeric emulsion technology in subjects with moderate or severe acne. Methods: A total of 1614 subjects, 9 years and older were randomized to receive tazarotene 0.045% lotion or vehicle in two identical double-blind, randomized, vehicle-controlled 12-week studies evaluating safety and efficacy (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion counts and using Evaluator Global Severity Scores [EGSS]). Treatment success was defined as at least a 2-grade improvement in EGSS and ‘clear’/’almost clear’ and efficacy assessed through reduction in lesion counts. In addition, patients completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were assessed throughout. RESULTS Tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts at week 12. Mean percent reductions in inflammatory and noninflammatory lesions were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.045% lotion at week 12. Treatment success was achieved by 25.5% (Study 1) and 29.6% (Study 2) of subjects treated with tazarotene 0.045% lotion (both P<0.001 versus vehicle [13.0% and 17.3%, respectively]). Improvements in QoL domain scores were consistently greater with tazarotene. Tazarotene 0.045% lotion was well-tolerated. The most common treatment-related AEs were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). CONCLUSION Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. JJ Drugs Dermatol. 2020;19(1):70-77. doi:10.36849/JDD.2020.3977
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Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea.
Draelos, ZD, Gunt, H, Levy, SB
Journal of drugs in dermatology : JDD. 2019;(2):141-146
Abstract
Background: Rosacea is characterized by irritation associated with erythema, telangiectasias and papules/pustules. Whole formula nature-based sensitive skin products are formulated to maintain skin barrier and appropriate hydration that can lead to soothing benefits. Objective: To evaluate the efficacy and tolerability of a regimen consisting of a cleanser containing natural oils, beeswax, and witch hazel and day and night creams containing natural oils, glycerin, and botanical anti-inflammatories (NR); and a synthetic dermatologist-recommended regimen of cetyl alcohol, sodium lauryl sulphate-containing cleanser, and glycerin, polyisobutene-containing lotion (CR) in subjects with rosacea. Methods: 80 female subjects with rosacea who received 6 weeks of 0.75% metronidazole gel, were randomized to receive NR or CR, twice daily, for 4 weeks in conjunction with the gel. Blinded investigator global assessment of rosacea, investigator-rated, and subject-rated overall skin appearance was assessed using a 5-point scale (0=none, 4=severe) at baseline, 2 weeks, and 4 weeks. Noninvasive skin assessments for skin hydration and skin barrier function were made by corneometry and TEWL, respectively. Results: NR resulted in improvement in investigator global assessment of rosacea measures at 4 weeks from baseline (erythema, 28%; telangiectasia, 26%; papules/pustules, 34%: P<0.001) and CR resulted in a 8 to 12% improvement. Differences between treatments were statistically significant. Overall skin appearance measured by the investigator was clinically and statistically improved from baseline by 32% and 12% with NR and CR, respectively. Overall skin appearance measured by subjects was improved by both NR and CR from baseline with no differences between treatments. Both regimens improved barrier function from baseline to week 4 (13%, NR; 14%, CR). NR decreased hydration by 21% from baseline at week 4 while CR increased hydration by 14% (P<0.001 from NR). No clinically significant tolerability issues were reported in either regimen at week 4. Conclusion: NR was effective, well tolerated, and superior to CR in the management of rosacea, concomitantly treated with metronidazole. National Clinical Trial Identifier: NCT03392558 J Drugs Dermatol. 2019;18(2):141-146.
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Calcipotriol/betamethasone ointment compared to narrow-band UVB in plaque psoriasis: first clinical and ultrasonographic study.
Polańska, A, Gaura, T, Bowszyc-Dmochowska, M, Osmola-Mańkowska, A, Olek-Hrab, K, Adamski, Z, Żaba, R, Dańczak-Pazdrowska, A
International journal of dermatology. 2019;(1):108-113
Abstract
INTRODUCTION A wide range of treatments are available for psoriasis, including pharmaceuticals and phototherapy. Calcipotriol/betamethasone dipropionate and narrow-band ultraviolet phototherapy (NB-UVB) are both effective monotherapies for psoriasis; however, these two therapies have never been directly compared in a prospective clinical study. In this study, we compared the efficacy of combined calcipotriol/betamethasone dipropionate to NB-UVB in psoriatic patients with Psoriasis Area Severity Index (PASI) 9-10 treated in a routine clinical practice. PATIENTS AND METHODS This prospective, observational study included 58 consecutive patients (age range, 19-65 years) diagnosed with recurrent chronic small plaque psoriasis. Patients were offered either topical therapy with a two-compound ointment containing calcipotriol (50 μm/g) and betamethasone dipropionate (0.5 mg/g) or NB-UVB (311 nm). Disease severity was assessed at baseline and posttreatment according to PASI and target lesion score (TLS) and by high-frequency (20 MHz) ultrasonography (HF-USG). RESULTS No statistically significant difference between the groups was observed in baseline or posttreatment PASI scores. Both treatments resulted in substantial reductions in PASI 85% and 82%, respectively, for the calcipotriol/betamethasone group and the NB-UVB group. Both treatments significantly decreased the subepidermal low echogenic band (SLEB) thickness, with no significant differences between the two groups in terms of the percentage reduction in SLEB. CONCLUSIONS This study demonstrates, for the first time, that NB-UVB phototherapy and fixed combination calcipotriol/betamethasone ointment are equally effective in treating plaque psoriasis in patients with PASI 9-10 in routine clinical practice. In addition, measurement of SLEB thickness with HF-USG may be a useful objective parameter to assess skin lesions.
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Evaluation of the efficacy of transdermal drug delivery of calcipotriol plus betamethasone versus tacrolimus in the treatment of vitiligo.
Ibrahim, ZA, Hassan, GF, Elgendy, HY, Al-Shenawy, HA
Journal of cosmetic dermatology. 2019;(2):581-588
Abstract
BACKGROUND Vitiligo is a common pigmentary disorder affecting about 1% of the general population. There are numerous medical and surgical treatments. Microneedling is an evolving treatment technique for an expanding number of dermatologic conditions. It is used also to augment transdermal drug delivery through pores created in the stratum corneum. AIM: To evaluate the efficacy of microneedling with tacrolimus versus its efficacy with calcipotriol plus betamethasone in vitiligo treatment. METHODS Twenty-five patients having vitiligo were selected and their symmetrical patches were divided into side A (right side) which received microneedling with dermapen and topical calcipotriol plus betamethasone and side B (left side) which received microneedling and topical tacrolimus. Every patient received a session every 2 weeks for a maximum 6 months (12 sessions) and follow-up for 3 months. Skin biopsies were taken before and after the treatment to evaluate the clinical results. RESULTS On side A, 60% of the patients showed excellent improvement while 32% showed excellent response on side B. The mean percentage of improvement was significantly higher on side A than side B (P = 0.017* ). It was effective in the most resistant sites of vitiligo such as: elbows, knees, extremities, and acral area. Histopathological examination showed a significant expression of HMB45 on side A more than side B (P = 0.005* ). CONCLUSION The combination of microneedling with calcipotriol plus betamethasone is more effective than its combination with tacrolimus. They are both effective in resistant sites. Both methods are safe, cheap, and good tolerated office techniques with minimal side effects.
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Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin.
Del Rosso, JQ, Stein Gold, L, Johnson, SM, Rueda, MJ, Baldwin, H, Lain, EL, Landis, M, Rendon, M, Tanghetti, E, Weiss, J
Journal of drugs in dermatology : JDD. 2018;(3):264-273
Abstract
INTRODUCTION Acne treatment guidelines suggest a combination approach with topical therapy including a topical retinoid, benzoyl peroxide and an oral antibiotic, or oral isotretinoin (OI), as first-line treatment options for severe acne vulgaris (AV). This study evaluated the efficacy and safety of a daily regimen of 0.3% adapalene and 2.5% benzoyl peroxide (0.3% A/BPO) gel and oral doxycycline 100 mg twice daily in severe (nonnodulocystic, non-conglobate) inflammatory AV.
METHODS This was a phase 4, 12-week, single-arm, openlabel, multi-center investigational study. Subjects (males and females, 12 or older, with severe inflammatory AV, Investigator Global Assessment [IGA] 4, and less than equal to 4 nodulocystic lesions, n=186) were considered OI candidates at baseline by the investigator. OI candidacy was re-evaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (week 12), IGA success (defined as IGA 0 [Clear] or 1 [Almost Clear], weeks 4, 8, and 12), percent reduction in lesions (weeks 4, 8, and 12), and subject questionnaires (week 12). Safety assessments included adverse events (AEs) and tolerability.
RESULTS Mean IL counts were significantly reduced from baseline to the end of the study (mean [SD]; baseline, 44.8 (21.73); week 12, 14.8 (16.11); mean percent reduction, 66.2% [30.47]; P less than .0001). By week 12, 37.1% of subjects achieved IGA Success (n=69, P less than .0001). Most subjects self-reported at least moderate improvement in AV (90.2%), and were "Satisfied" or "Very Satisfied" with the study treatment overall (83.2%). 41.9% of the subjects were no longer considered by their investigator to be OI candidates at week 4. At 12 weeks, only 19.9% were still considered OI candidates.
CONCLUSION 0.3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used. ClinicalTrials.gov identifier: NCT02899000
J Drugs Dermatol. 2018;17(3):264-273.
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Clinical and instrumental evaluation of the efficacy of an emollient cream and a cleansing cream in the management of mild to moderate adulthood atopic dermatitis.
Cristaudo, A, Lupi, F, Mariano, M, Cianchini, G, De Rocco, M, De Pità, O
Giornale italiano di dermatologia e venereologia : organo ufficiale, Societa italiana di dermatologia e sifilografia. 2018;(6):855-859
Abstract
BACKGROUND Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disorder which may persist or directly start in adults. This is an open-label prospective study to clinically and instrumentally evaluate the effects of an emollient glycerin and paraffin-based cream and a gentle refatting cleanser in the management of mild to moderate adulthood AD. METHODS Fifty adult patient with mild to moderate AD were recruited at the Professional Dermatology and Allergology Outpatient Clinic of the San Gallicano Dermatological Institute of Rome, between November 2016 and January 2018. The patients applied the emollient cream twice daily for 2 months. To assess the efficacy of the cream, two different areas of treatment were identified in each patient's limbs. The outcome was evaluated at 30 days (T1) and 60 days (T2) of treatment comparing to baseline (T0) by means of clinical evaluation, Dermatology Life Quality Index (DLQI) questionary, transepidermal waterloss (TEWL) and corneometry measurements. RESULTS Clinical evaluation showed significative improvement of skin xerosis, fissuring, itching and erythema. Consistently, a significative reduction of TEWL and an improvement in skin hydration was also detected. A significative improvement of DLQI score was also detected. CONCLUSIONS Study treatment was well tolerated and showed significative improvement of clinical and instrumental parameters evaluated. The topical daily use of an emollient glycerin and paraffin-based cream and a gentle refatting cleanser seems to be a useful tool in the treatment of mild to moderate adulthood AD improving quality of life.
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Ixekizumab treatment shows a neutral impact on cardiovascular parameters in patients with moderate-to-severe plaque psoriasis: Results from UNCOVER-1, UNCOVER-2, and UNCOVER-3.
Egeberg, A, Wu, JJ, Korman, N, Solomon, JA, Goldblum, O, Zhao, F, Mallbris, L
Journal of the American Academy of Dermatology. 2018;(1):104-109.e8
Abstract
BACKGROUND The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown. OBJECTIVE To investigate cardiovascular-related parameters in patients with psoriasis treated with ixekizumab. METHODS In phase 3 trials, patients with moderate-to-severe psoriasis were randomized and treated with placebo, ixekizumab, or etanercept during the induction period (weeks 0-12; UNCOVER-1, UNCOVER-2, and UNCOVER-3). At week 12, responders were rerandomized to receive placebo or ixekizumab through the maintenance period (weeks 12-60; UNCOVER-1 and UNCOVER-2). Laboratory measures (fasting lipid profiles, glucose level, or high-sensitivity C-reactive protein [hsCRP] level), weight, blood pressure, and electrocardiograms were obtained through 60 weeks. RESULTS Baseline parameters were within normal ranges with the exception of elevated triglyceride and hsCRP levels. After maintenance dosing, no significant changes were observed versus placebo for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglyceride, apolipoprotein A1, apolipoprotein B, or fasting glucose levels or for systolic/diastolic blood pressure at 60 weeks. Importantly, low-density lipoprotein-to-high-density lipoprotein ratios remained stable during the induction and maintenance periods. HsCRP concentrations were significantly reduced versus placebo at 12 weeks and remained reduced at 60 weeks, although not significantly. Although transient changes were observed for some parameters during the induction period, these changes did not persist into the maintenance period. LIMITATIONS A lack of echocardiogram evaluations. CONCLUSIONS Ixekizumab had a neutral impact on cardiovascular-related parameters in patients with psoriasis.
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A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial.
Svendsen, MT, Andersen, F, Andersen, KH, Pottegård, A, Johannessen, H, Möller, S, August, B, Feldman, SR, Andersen, KE
The British journal of dermatology. 2018;(5):1062-1071
Abstract
BACKGROUND Adherence to topical psoriasis treatments is low, which leads to unsatisfactory treatment results. Smartphone applications (apps) for patient support exist but their potential to improve adherence has not been systematically evaluated. OBJECTIVES To evaluate whether a study-specific app improves adherence and reduces psoriasis symptoms compared with standard treatment. METHODS We conducted a randomized controlled trial (RCT, clinicaltrials.gov registration: NCT02858713). Patients received once-daily medication [calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam] and were randomized to no app (n = 66) or app intervention (n = 68) groups. In total, 122 patients (91%) completed the 22-week follow-up. The primary outcome was adherence, which was defined as medication applied ≥ 80% of days during the treatment period and assessed by a chip integrated into the medication dispenser. Secondary outcomes were psoriasis severity measured by the Lattice System Physician's Global Assessment (LS-PGA) and quality of life, measured using the Dermatology Life Quality Index (DLQI) at all visits. RESULTS Intention-to-treat analyses using regression was performed. More patients in the intervention group were adherent to Cal/BD cutaneous foam than those in the nonintervention group at week 4 (65% vs. 38%, P = 0·004). The intervention group showed a greater LS-PGA reduction than the nonintervention group at week 4 (mean 1·86 vs. 1·46, P = 0·047). A similar effect was seen at weeks 8 and 26, although it did not reach statistical significance. CONCLUSIONS This RCT demonstrates that the app improved short-term adherence to Cal/BD cutaneous foam treatment and psoriasis severity.
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Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study.
Paul, C, Leonardi, C, Menter, A, Reich, K, Gold, LS, Warren, RB, Møller, A, Lebwohl, M
American journal of clinical dermatology. 2017;(3):405-411
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Abstract
BACKGROUND Fixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy. OBJECTIVE The objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study. METHODS Patients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index. RESULTS Seventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001). CONCLUSION Cal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS. GOV IDENTIFIER NCT02132936.