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, Rituparna; Sirka, Chandra Sekhar; Rahman, M A; Srinivasan, Anand; Parida, Swayam Pragyan; Hota, Debasish

doi:10.1007/s40261-017-0568-2

Cited by 12 publications

(13 citation statements)

References 17 publications

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“…16 The main pharmacological effects of tazarotene are normalized cell differentiation, reduced hyperkeratosis, reversal of excessive proliferation, and anti-inflammatory effects on keratinocytes. 9,[17][18][19][20] Clindamycin phosphate, a commonly used drug for local treatment of acne vulgaris, has no activity in vitro and is hydrolyzed to clindamycin by phospholipase in vivo to become an active substance. 21 The antibacterial mechanism of clindamycin is that it acts on the 50S subunit of bacteria, inhibits peptide chain lengthening, and affects protein synthesis.…”

Section: Discussionmentioning

confidence: 99%

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Safety, Tolerability, and Pharmacokinetics of Tazarotene Clindamycin Cream: A Single‐Dose, 3‐Period Crossover Study

Zhang

Yang

et al. 2020

Clinical Pharm in Drug Dev

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The current study compared the safety, tolerability, and pharmacokinetics of the new compound pharmaceutical preparation tazarotene clindamycin cream, and 2 single pharmaceutical preparations, tazarotene cream and clindamycin phosphate gel. Twelve healthy volunteers were enrolled in this single-center, single-blind, 3-treatment, 3-period crossover, single-dose randomized study. An 800-cm 2 area on volunteers' backs was evenly smeared with 1.6 g of the test preparation to form a film. Blood samples were collected at predetermined time points for pharmacokinetic analysis. Safety and tolerability were assessed via skin reaction evaluation and clinical laboratory tests. The incidences of skin reactions were 18.2% for tazarotene clindamycin cream, 25.0% for tazarotene cream, and 18.2% for clindamycin phosphate gel. There were no significant differences in safety or tolerability among the 3 groups. Erythema, desquamation, and pruritus occurred in 7 volunteers, but no burning or tingling occurred. All adverse events were mild and resolved spontaneously, and there were no severe adverse events. The respective maximum plasma concentrations of tazarotenic acid after local administration of tazarotene clindamycin cream and tazarotene cream were 11 ± 5 pg/mL and 18 ± 12 pg/mL, and the areas under the curve within 72 hours were 444 ± 341 pg • h/mL and 692 ± 462 pg • h/mL.

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Section: Discussionmentioning

confidence: 99%

“…It also exhibits excellent pharmacokinetic characteristics in many types of diseases. 8 Numerous trials have shown that the combination of tazarotene and clindamycin is more effective than tazarotene alone, [9][10][11] but the pharmacokinetics of tazarotene with clindamycin have not been reported.…”

mentioning

confidence: 99%

Safety, Tolerability, and Pharmacokinetics of Tazarotene Clindamycin Cream: A Single‐Dose, 3‐Period Crossover Study

Zhang

Yang

et al. 2020

Clinical Pharm in Drug Dev

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“…Patients aged between 12 and 30 years, suffering from mild (Global Acne Grading System [GAGS], 1-18) to moderate (GAGS, [19][20][21][22][23][24][25][26][27][28][29][30] forms of AV (ICD-10-CM code: L70.0), 20 of either sex, literate in Bengali and consenting to participate, were eligible to be included. Exclusion criteria were patients with severe (GAGS, 31-38) to very severe (GAGS, 39 or higher) forms of AV, any uncontrolled systemic or psychiatric diseases or life-threatening illness (e.g., cancer, diabetes, epilepsy, severe asthma, ischemic heart diseases), a selfreported immuno-compromised state, pregnancy, puerperal and lactating women, subjects on hormonal contraceptives, steroids or non-steroidal anti-inflammatory drugs, those using oil-based cosmetics or undergoing…”

Section: Participantsmentioning

confidence: 99%

Efficacy of Individualized Homeopathic Medicines in Treatment of Acne Vulgaris: A Double-Blind, Randomized, Placebo-Controlled Trial

et al. 2022

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Introduction Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. Acne vulgaris (AV) is among the diseases that directly affect quality of life. This trial evaluated the efficacy of individualized homeopathic medicines (IHM) against placebo in AV. Methods In this double-blind, randomized, placebo-controlled trial conducted at the National Institute of Homoeopathy, India, 126 patients suffering from AV were randomized in a 1:1 ratio to receive either IHM (verum) in centesimal potencies or identical-looking placebo (control). The primary outcome measure was the Global Acne Grading System score; secondary outcomes were the Cardiff Acne Disability Index and Dermatology Life Quality Index questionnaires — all measured at baseline and 3 months after the intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. Results Overall, improvements were greater in the IHM group than placebo, with small to medium effect sizes after 3 months of intervention; however, the inter-group differences were statistically non-significant. Sulphur (17.5%), Natrum muriaticum (15.1%), Calcarea phosphorica (14.3%), Pulsatilla nigricans (10.3%), and Antimonium crudum (7.1%) were the most frequently prescribed medicines; Pulsatilla nigricans, Tuberculinum bovinum and Natrum muriaticum were the most effective of those used. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. Conclusion There was non-significant direction of effect favoring homeopathy against placebo in the treatment of AV. Trial Registration: CTRI/2018/11/016248; UTN: U1111–1221–8164.

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“…Comedão fechado e comedão aberto Pápulo-pustular Pápula: lesão cutânea primária, sólida (0,5 -1 cm) Pustula: lesão cutânea primária, líquida, contendo pús (0,5 -1 cm) 36 ainda indisponível na Europa. 11 A concentração 0,1% é a única aprovada pela FDA, sendo a espuma adequada na acne moderada a severa em idade superior a 12 anos.…”

Section: Comedónicaunclassified

Opções Terapêuticas Farmacológicas na Acne vulgar

Freitas

Velho

2021

SPDV

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A acne vulgar é uma patologia crónica da unidade pilossebácea caracterizada por polimorfismo cutâneo, sendo das mais prevalentes na adolescência. Pode originar sequelas físicas, como cicatrizes desfigurantes, e psicológicas, nomeadamente diminuição da qualidade de vida e função psicossocial. Assim, torna-se fundamental uma estratégia terapêutica eficaz de modo a promover a sua resolução e, simultaneamente, minimizar a presença destas sequelas. Atualmente, os fármacos disponíveis são diversos, obrigando, na sua seleção, à avaliação biopsicossocial do doente. Estudos recentes têm apontado novos agentes terapêuticos promissores, nomeadamente alternativas aos retinóides tópicos, isotretinoína oral, antiandrogénios orais e antibióticos. Estes poderão permitir uma redução da resistência antibiótica e consequente aumento da eficácia com redução substancial dos efeitos adversos. O melhor perfil de segurança e tolerabilidade poderá otimizar a abordagem terapêutica atual.

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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

Abstract: ClinicalTrials.gov Identifier: NCT02721173.

Cited by 12 publications

References 17 publications

Safety, Tolerability, and Pharmacokinetics of Tazarotene Clindamycin Cream: A Single‐Dose, 3‐Period Crossover Study

Safety, Tolerability, and Pharmacokinetics of Tazarotene Clindamycin Cream: A Single‐Dose, 3‐Period Crossover Study

Efficacy of Individualized Homeopathic Medicines in Treatment of Acne Vulgaris: A Double-Blind, Randomized, Placebo-Controlled Trial

Opções Terapêuticas Farmacológicas na Acne vulgar

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