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Isotretinoin

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1. Covid-19: Guidance For Managing Patients On Isotretinoin During the Coronavirus Pandemic

Covid-19: Guidance For Managing Patients On Isotretinoin During the Coronavirus Pandemic British Association of Dermatologists COVID-19 – Isotretinoin guidance First published 26.03.20 1 GUIDANCE FOR MANAGING PATIENTS ON ISOTRETINOIN DURING THE CORONAVIRUS PANDEMIC This is a very fluid situation and guidance may change Please note that any BAD advice and guidance produced as a result of COVID-19 would still require authorisation by Trusts which indemnify members. Most will be guided (...) by available evidence and responsible medical opinion, and that any deviation from standard practice needs to be documented clearly and the reasons stated. • Dermatologists should only be starting or continuing patients on isotretinoin where the risks are outweighed by the benefits. This needs to be considered carefully in light of the need to reduce face-to-face consultations in the current pandemic, and the uncertainty of reliable follow-up/monitoring over the coming months. • If there is no risk

2020 British Association of Dermatologists

2. Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido

Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido - GOV.UK GOV.UK uses cookies to make the site simpler. Search Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne (...) . Published 26 October 2017 From: Therapeutic area: Contents Advice to healthcare professionals: be aware of reports of sexual side effects, including erectile dysfunction and decreased libido, in patients taking oral isotretinoin, indicated for severe acne the exact incidence of these adverse reactions is unknown but considering the number of patients in the UK taking the medicine, reports are understood to be rare report any suspected adverse reactions to isotretinoin or other medicines on a Sexual

2017 MHRA Drug Safety Update

3. Compliance with Pregnancy Prevention Recommendations for Isotretinoin in Estonia in 2012–2016 Full Text available with Trip Pro

Compliance with Pregnancy Prevention Recommendations for Isotretinoin in Estonia in 2012–2016 Isotretinoin is an effective treatment for severe acne; no alternative treatment has an equal therapeutic effect. The teratogenic effects of isotretinoin can be avoided, and numerous recommendations and regulations are in force to minimize the risk of pregnancy during treatment.To describe isotretinoin prescription patterns for women aged 15-45 years, assess the concomitancy of isotretinoin (...) and contraceptive use, and determine the rate of potential isotretinoin-exposed pregnancies in Estonia.This retrospective, nationwide, population-based, cohort study derived data from national health insurance databases and included female patients aged 15-45 years in Estonia for whom one or more prescriptions for isotretinoin were dispensed between 2012 and 2016. The main outcome was the proportion of women who used systemic isotretinoin and had a concomitant record of (hormonal or intrauterine) contraception

2018 Drugs - real world outcomes

4. Compliance with national guidelines on isotretinoin: where are we 2 years since the last audit? Results of the National Isotretinoin Re-Audit 2014. (Abstract)

Compliance with national guidelines on isotretinoin: where are we 2 years since the last audit? Results of the National Isotretinoin Re-Audit 2014. In 2010, the British Association of Dermatologists (BAD) published clinical guidelines for the safe introduction and continued use of isotretinoin in patients with acne in the UK. The BAD provides UK dermatologists with a facility for national audit, and it undertook an audit on compliance with these guidelines in 2012.To determine current clinical (...) practices relating to use of isotretinoin among dermatologists in the UK (including geographical variations) as measured against BAD standards, and to ascertain any improvement since the 2012 audit.The 2012 isotretinoin audit proforma was used, with additional questions on clinical setting, complaints and litigation. A web-based survey tool was used for data entry and submission, with email invitation to working, UK-based BAD members (n = 1226) in December 2013 and weekly reminders during the 8.5-week

2017 Clinical & Experimental Dermatology

5. Evaluation of the efficacy and safety of oral isotretinoin versus topical isotretinoin in the treatment of plane warts: a randomized open trial. (Abstract)

Evaluation of the efficacy and safety of oral isotretinoin versus topical isotretinoin in the treatment of plane warts: a randomized open trial. Plane warts are a common therapeutic problem. Our aim was to assess the efficacy and safety of oral versus topical isotretinoin in the treatment of plane warts.Forty patients with multiple plane warts were randomized into two groups. Group A was treated with oral isotretinoin capsules in the dose of 0.5 mg/kg/d and Group B with topical isotretinoin (...) (38%) patients had complete remission and six (46%) had partial remission, whereas two patients had no remission. The difference was statistically significant between two groups; P < 0.0001. The most common side effect in Group A was cheilitis. In Group B, five patients had to be dropped because they developed severe erythema and scaling.Oral isotretinoin showed better and earlier response than topical isotretinoin. Oral isotretinoin should definitely be given a trial particularly in cases

2017 International Journal of Dermatology Controlled trial quality: uncertain

6. Differences in isotretinoin start, interruption, and early termination across race and sex in the iPLEDGE era. Full Text available with Trip Pro

Differences in isotretinoin start, interruption, and early termination across race and sex in the iPLEDGE era. iPLEDGE is the mandatory regulatory program for isotretinoin in the United States, aimed to prevent isotretinoin-related teratogenicity. However, little is known about potential unintended impact of the program, including delay in isotretinoin initiation, course interruption, and premature termination, which may vary across sex and racial domains.To determine whether differences (...) in isotretinoin start, interruption, and completion exist across sex and racial domains and whether iPLEDGE regulations contribute to such differences.Retrospective review of isotretinoin courses of patients prescribed isotretinoin for acne at the Brigham & Women's Hospital and Massachusetts General Hospital from 2008-2016.418 patients were included in analysis after being tightly matched across age and gender. 43.5% of non-white patients ended their course early compared to 30.1% of white patients (p = 0.010

2019 PLoS ONE

7. Is less more with isotretinoin and acne?

Is less more with isotretinoin and acne? Tools for Practice is proudly sponsored by the Alberta College of Family Physicians (ACFP). ACFP is a provincial, professional voluntary organization, representing more than 4,000 family physicians, family medicine residents and medical students in Alberta. Established over fifty years ago, the ACFP strives for excellence in family practice through advocacy, continuing medical education and primary care research. www.acfp.ca March 14, 2016 Is less more (...) with isotretinoin and acne? Clinical Question: What is the efficacy and tolerability of low-dose compared to conventional dose isotretinoin in the treatment of acne? Bottom-line: Small randomized controlled trials (RCTs) and observational studies demonstrate low-dose (~20mg/day) isotretinoin improves acne similar to conventional dosing. Low-dose may reduce common side effects (chapped lips, dry skin, epistaxis) by 16-35% but may be associated with increased relapse rates, particularly with severe acne

2016 Tools for Practice

8. Response to the correspondence: a randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization. (Abstract)

Response to the correspondence: a randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization. 31350762 2019 12 04 1365-4632 58 10 2019 10 International journal of dermatology Int. J. Dermatol. Response to the correspondence: a randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization. e186-e187 10.1111/ijd.14516 Ianhez Mayra M 0000-0003-3604-3128

2019 International Journal of Dermatology Controlled trial quality: uncertain

9. The Clinical Utility of Laboratory Monitoring During Isotretinoin Therapy for Acne and Changes to Monitoring Practices Over Time. (Abstract)

The Clinical Utility of Laboratory Monitoring During Isotretinoin Therapy for Acne and Changes to Monitoring Practices Over Time. Due to concerns about hypertriglyceridemia, liver enzyme abnormalities, and leukopenia during isotretinoin therapy for acne, patients are often followed closely with routine laboratory monitoring, although the value of this practice has been questioned.We conducted a cohort study of patients receiving isotretinoin for acne between January 1, 2008 and June 30, 2017 (...) using the OptumInsights Electronic Health Record Database to evaluate the frequency of laboratory abnormalities. Poisson regression was used to evaluate for changes to the frequency of routine laboratory monitoring over time.Among 1,863 patients treated with isotretinoin, grade 3 or greater triglyceride and liver function testing abnormalities were noted in fewer than 1% and 0.5% of patients screened, respectively. No grade 3 or greater cholesterol or complete blood count abnormalities were observed

2019 Journal of American Academy of Dermatology

10. The combined effect of tranilast 8% liposomal gel on the final cosmesis of acne scarring in patients concomitantly treated by isotretinoin: Prospective double blind split-face study. (Abstract)

The combined effect of tranilast 8% liposomal gel on the final cosmesis of acne scarring in patients concomitantly treated by isotretinoin: Prospective double blind split-face study. Tranilast, N-(3,4-dimethoxycinnaoyl) anthranilic acid has never been investigated for the prevention and treatment of acne scars.To evaluate the efficacy and safety of tranilast 8% gel in improving the final appearance of patients with acne scarring concomitantly treated by isotretinoin.One-half of the faces of 40 (...) lower (better outcome) for the tranilast-treated side than the placebo-treated areas in patients concomitantly treated with isotretinoin (P < 0.001). All the isotretinoin-treated patients reported greater satisfaction and better general improvement in the skin's appearance and texture, as well as greater improvement of pigmentary and redness alteration on the tranilast 8% gel-treated side compared to the control side.Combined topical application of tranilast 8% gel twice daily with oral isotretinoin

2019 Clinical & Experimental Dermatology Controlled trial quality: uncertain

11. Isotretinoin and risk factors for suicide attempt: a population-based comprehensive case series and nested case-control study using 2010-2014 French Health Insurance Data. (Abstract)

Isotretinoin and risk factors for suicide attempt: a population-based comprehensive case series and nested case-control study using 2010-2014 French Health Insurance Data. Although the causal role of isotretinoin in suicidal behaviour is controversial, suicide attempts (SA) do occur among patients taking isotretinoin.To describe patient profiles and the management of isotretinoin among patients who committed or attempted suicide under treatment. To assess the risk factors for SA under (...) isotretinoin.We performed a comprehensive case series of suicides and SAs under isotretinoin, and a case-control study, using Nationwide French Health Insurance database. The main analysis compared cases (subjects with a SA during a course of isotretinoin) to controls, individually matched for age, gender and rank of the current course; controls were to be exposed to isotretinoin at the index date (date of SA for the corresponding cases). The patients' psychiatric history at isotretinoin initiation

2019 Journal of the European Academy of Dermatology and Venereology

12. US Food and Drug Administration Reports of Pregnancy and Pregnancy-Related Adverse Events Associated With Isotretinoin. Full Text available with Trip Pro

US Food and Drug Administration Reports of Pregnancy and Pregnancy-Related Adverse Events Associated With Isotretinoin. iPLEDGE is a rigorous program initiated in 2006 to reduce fetal exposure to isotretinoin, a disease-modifying medication for acne that carries a risk of teratogenesis. Despite the imposition of iPLEDGE requirements on patients and clinicians, the scope of isotretinoin-related adverse events is unknown.To determine the frequency and rate of pregnancy and pregnancy-related (...) adverse events among women taking isotretinoin reported to the US Food and Drug Administration (FDA).Pregnancy reports from the FDA Adverse Event Reporting System, a public database of medication adverse event reports filed by prescribers, consumers, and manufacturers, were used to perform a retrospective analysis of pregnancy-related adverse events associated with isotretinoin from January 1, 1997, to December 31, 2017. Each individual reporting any pregnancy-related adverse event signified 1

2019 JAMA dermatology (Chicago, Ill.)

13. Psychiatric Adverse Events in Patients Taking Isotretinoin as Reported in a Food and Drug Administration Database From 1997 to 2017. (Abstract)

Psychiatric Adverse Events in Patients Taking Isotretinoin as Reported in a Food and Drug Administration Database From 1997 to 2017. Isotretinoin is a highly effective medication for severe acne. Although no causal link between isotretinoin and psychiatric adverse effects has been established, widespread media reporting of depression and suicidality with use of isotretinoin have raised concerns in both patients and clinicians and generated numerous cases of costly litigation.To evaluate reports (...) of psychiatric adverse events associated with isotretinoin use submitted to the US Food and Drug Administration from January 1, 1997, through December 31, 2017.This retrospective study evaluated reports of psychiatric adverse events with isotretinoin as the primary suspect drug in the US Food and Drug Administration's Adverse Event Reporting System from 1997 through 2017. Publicly available data on number of patients enrolled in the iPLEDGE program were used to calculate rates of completed suicide per

2019 JAMA dermatology (Chicago, Ill.)

14. Response to: A randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization. (Abstract)

Response to: A randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization. 30916781 2019 12 04 1365-4632 58 10 2019 10 International journal of dermatology Int. J. Dermatol. Response to: A randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization. e185-e186 10.1111/ijd.14449 Misitzis Angelica A 0000-0002-8809-9687 Department of Dermatology, Alpert

2019 International Journal of Dermatology Controlled trial quality: uncertain

15. Comparing the Efficacy of Low Dose and Conventional Dose of Oral Isotretinoin in Treatment of Moderate and Severe Acne Vulgaris. Full Text available with Trip Pro

Comparing the Efficacy of Low Dose and Conventional Dose of Oral Isotretinoin in Treatment of Moderate and Severe Acne Vulgaris. This study was conducted to compare the effect of low-dose isotretinoin with its conventional dose in patients with moderate and severe acne.This was a clinical trial conducted on 60 male and female patients with moderate and severe acne vulgaris. The patients were divided into two treatment groups: 0.5 mg/kg/day isotretinoin capsule and low-dose isotretinoin capsule (...) all the patients had dry lips.According to the same severity of the acne in two groups in different study periods, as well as fewer side effects and more patients' satisfaction, the low-dose isotretinoin can be considered in the treatment of acne.

2019 Journal of research in pharmacy practice Controlled trial quality: uncertain

16. Efficacy of Oral Isotretinoin in Combination with Desloratadine in the Treatment of Common Vulgaris Acne in Vietnamese Patients. Full Text available with Trip Pro

Efficacy of Oral Isotretinoin in Combination with Desloratadine in the Treatment of Common Vulgaris Acne in Vietnamese Patients. To evaluate the efficacy of oral isotretinoin used alone and in combination with desloratadine in the treatment of moderate acne vulgaris.A comparative clinical trial was undertaken to evaluate the efficacy of oral isotretinoin alone and in combination with desloratadine in the treatment of 62 moderate acne vulgaris patients. Patients were randomised into two groups (...) with 31 patients in each group. Each studied group's patient took 20 mg isotretinoin and 5 mg desloratadine per day. In the control group, patients took only 20 mg isotretinoin per day. The treatment time was 16 weeks. The evaluation and follow-up were done at week 2, 4, 8, 12 and 16 of the treatment.The studied group had a better curative rate than the control group (45.2% versus 22.6%). The average number of inflammatory lesions in the studied group was significantly lower than the control group

2019 Open access Macedonian journal of medical sciences Controlled trial quality: uncertain

17. The effect of continuous high versus low dose oral isotretinoin regimens on dermcidin expression in patients with moderate to severe acne vulgaris. (Abstract)

The effect of continuous high versus low dose oral isotretinoin regimens on dermcidin expression in patients with moderate to severe acne vulgaris. The continuous low dose (LD) isotretinoin is frequently used in the treatment regimen for acne vulgaris. However, data about its antimicrobial are lacking. The present study aimed to investigate dermcidin expression and the effects of low and conventional dose isotretinoin on its expression in acne vulgaris patients. Skin dermcidin expression (...) was investigated in 30 patients with moderate-severe acne vulgaris and 15 healthy control subjects using ELISA. 15 patients were given continuous low-dose isotretinoin (20 mg/day) and the other 15 given the conventional high dose (0.5 mg/kg/day). Skin biopsies were taken at the start of the study and 6 months later. Dermcidin was significantly lower in acne vulgaris patients (p < .001). Both isotretinoin regimens significantly raised dermcidin levels compared to pre-treatment values (p < .001). Relapse after

2019 Dermatologic therapy Controlled trial quality: uncertain

18. Abnormal liver function tests in acne patients receiving isotretinoin. (Abstract)

Abnormal liver function tests in acne patients receiving isotretinoin. Background: Isotretinoin is an efficacious treatment option for severe acne. Although isotretinoin often causes mild liver enzyme elevation, how acne patients should be monitored on isotretinoin therapy is not well characterized. Objective: The purpose of this study was to assess the management and clinical outcome of acne patients with abnormal aspartate transaminase (AST) and alanine aminotransferase (ALT) when receiving (...) isotretinoin. Methods: A retrospective chart review was conducted in acne subjects with abnormal AST and ALT levels receiving isotretinoin. Abnormal liver enzymes were graded using the Common Terminology Criteria for Adverse Events version 5. Results: Of 108 subjects with abnormal liver enzymes, 79 subjects were on isotretinoin 80 mg and 23 subjects were on isotretinoin 40 mg. Most abnormalities were during Month 1 of therapy (48). Of the 122 abnormal Grade 1 AST elevations, 40 normalized, 38 remained

2019 Journal of Dermatological Treatment

19. Isotretinoin in the treatment of hidradenitis suppurativa: a retrospective study. (Abstract)

Isotretinoin in the treatment of hidradenitis suppurativa: a retrospective study. Objective: Isotretinoin has been used off-label in hidradenitis suppurativa (HS) patients with variable results, making it difficult to predict which patients with HS are likely to benefit. Material and Methods: We conducted a retrospective review of HS patients who presented to UCLA HS clinic between August 2009 and March 2018 and collected data on their demographics, reported history of isotretinoin treatment (...) for HS, and treatment response. A number of patient variables were analyzed between the responders and non-responders to see if any were associated with a higher likelihood of a beneficial response. Results: Of the 209 patients, 39 (18.7%) reported prior treatment with isotretinoin. A beneficial response to isotretinoin was reported by 14 (35.9%) patients, while 25 (64.1%) patients reported no response. When comparing responders to non-responders, responders were more likely to have a history

2019 Journal of Dermatological Treatment

20. Isotretinoin is indirectly effective in sebocytes. Full Text available with Trip Pro

Isotretinoin is indirectly effective in sebocytes. In a recently published research letter Burney et al. demonstrated that isotretinoin (13-cis-retinoic acid, 13CRA) induced acnegenic changes in SEB-1 cultured human sebocytes1 . However, Melnik et al., suggested that the observed changes may largely be influenced by the Simian virus (SV)-40 immortalization of the used cell line, which may inhibit the p53 pathway and together with 13CRA lead to changes, such as the down-regulation

2019 British Journal of Dermatology

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