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Efficacy and adverse events of oral isotretinoin for acne: a systematic review. |
Doctors urged to reconsider controversial acne drug -- ScienceDaily.
A Review of Recent Isotretinoin Studies - Publication types
Because of this, there is a significant need for more research on alternative treatment options for moderate acne. Once weekly isotretinoin dosing has the potential to significantly improve moderate acne with good patient satisfaction and safety profile; however, no study findings on this treatment option have been published to date. The efficacy of isotretinoin, an oral vitamin A derivative, for treatment of acne has been well established. The traditional treatment course for severe acne consists of once to twice daily dosing 0.
Though efficacious, there are numerous reported side-effects due to achieving the cumulative dose rapidly by once to twice daily dosing, such as severe dry skin, lips, and eyes, as well as liver enzyme and lipid abnormalities. Because of this, there have been studies exploring alternative isotretinoin dosing regimens including microdose, lower daily dose regimens 0. Those who also analyzed adverse effect rates with alternative isotretinoin dosing found that these were either rarely observed or similar to conventional dosing.
Interestingly, rates of acne recurrence between alternative isotretinoin dosing and conventional dosing were similar at follow-up,6,7,9 despite a much older study from that found otherwise. Secondary endpoints include patient satisfaction and adverse effects. Participants are eligible for the study if their score is 3 or higher. An improvement in their visible acne is a score of 2, 1, or 0 at the end of the 4 months of treatment.
Secondary Outcome Measures : Number of Participants With a Change in Quality of Life [ Time Frame: Baseline, monthly, and end of treatment, total of 4 months ] Participants will use the Dermatology Life Quality Index survey which measures how much their skin problems affect their life. The higher the score the more their skin impacts their day to day activities.
An improvement in their quality of life is a lower score at 4 months compared to baseline score. Number of Side Effects Reported at the End of 4 Months [ Time Frame: through study completion, an average of 4 months ] Participants will fill out a survey regarding nonserious and serious adverse events.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Weekly Isotretinoin Therapy Study WIT The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : May 9, Last Update Posted : May 9, Study Description. The mainstay of treatment for moderate acne remains long courses of oral antibiotics despite emerging antibiotic resistance. The efficacy of daily to twice daily dosed isotretinoin, an oral vitamin A derivative, for treatment of severe acne has been well established.
The purpose of this study is to determine if once weekly dosed isotretinoin is effective for the treatment of patients with moderate acne. Additionally, the study aims to evaluate patient satisfaction and identify any adverse effects on this alternative dosing regimen. Detailed Description:. Drug Information available for: Isotretinoin. FDA Resources. Arms and Interventions. Outcome Measures. Participants will fill out a survey regarding nonserious and serious adverse events. Eligibility Criteria.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. The use of oral antibiotics before isotretinoin therapy in patients with acne. J Am Acad Dermatol. Epub Oct Antibiotic stewardship in dermatology: limiting antibiotic use in acne.
Current Issue. Aesthetics Corner. Allergen Focus. Board Review. Clinical Tips. Cover Story. NEA-Reviewed Content. NPF-Approved Content. NRS-Approved Content. The Dermatopathologist. Biological Pathways. Clinical Updates.
Dermatology Advances. FDA Alerts. How I Treat. Sponsored Content. Atopic Dermatitis. Hair and Trichology. Hidradenitis Suppurativa. Infectious Dermatology. Pediatric Dermatology. Practice Advances. Professional Development. Psoriatic Arthritis. Skin Cancer. Skin of Color. Fall Dermatology Week Dermatology Week AAD Annual Meeting. SDPA Fall. Copied to clipboard. Submit Feedback. Email Address. Popular Articles. Acne vulgaris is a ubiquitous disease, and its potential to cause significant psychological repercussions was first described over 55 years ago.
Acne vulgaris is a ubiquitous The Need for a Dermatology Shelf Exam. Medical school and residency applications will never be the same. Within the past few months, two major events have upended decades-long norms in medical education.
First, the United States Medical Licensing Pigmentary Changes Associated with Skin Aging. The pigmentary system is modified by the aging process and uneven pigmentation is one of the major changes associated with aging.
This article reviews the clinical, histological and ultrastructural changes of the pigmentary system that are The pigmentary system is Management of Nodules Post-Filler Injection. This case discusses the effective management of a nodule following injection of a filler. This case discusses the What Caused These Bluish Bumps?
A year-old man was brought to Latest Quizzes and Trivia. Which treatment improved health-related quality of life, fatigue, pain, and work productivity in adults with active psoriatic arthritis? Which treatment improved Which of the following procedures have a heightened risk of infection in hidradenitis suppurativa skin lesions? Take the quiz! Which of the following Trivia: Mental Health in Atopic Dermatitis.
The FDA first approved isotretinoin in for the treatment of severe, unresponsive acne. Since then, the drug has proven significantly effective for the treatment of hard-to-manage acne, but it has also seen its share of controversy related to side effects, including depression and irritable bowel disease IBD.
Two recent studies published in the Journal of the American Academy of Dermatology examine the efficacy of isotretinoin, the side effects that have been linked to the drug and new tools for monitoring and managing the adverse effects that have been linked to it.
A body of literature that has been expanding since the initial approval of isotretinoin almost 30 years ago reveals that a lower cumulative dose of the drug may increase the likelihood of treatment failure. Based on these findings, a group of researchers from NorthShore University Health System in Evanston, IL, and the UNC Chapel Hill Department of Dermatology set out to determine if a higher cumulative dose of isotretinoin would decrease the number of patients who require a second course of medication.
For the purposes of the study 1lead author Dean S. To be included, these studies had to evaluate patients who had been treated with isotretinoin for at least 4 consecutive months and followed after treatment for at least a year. In total, patients met the inclusion criteria for the review.
The primary outcome under investigation was which patients required further treatment and which patients continued to have acne that was severe enough for a second course of isotretinoin. In the study, a relapse was considered milder than a retrial; a relapse meant that patients required an additional course of topical medication for acne after treatment with isotretinoin, while a retrial warranted a second course of isotretinoin.
The researchers report that 16 of patients Morrell explained the specific indicators that differentiated a retrial and a relapse. The cumulative dose of isotretinoin did not significantly impact acne relapse, the authors wrote, but the take-home point is that patients who received a higher cumulative dose were less likely to require a second course of treatment.
The team also found that female patients were at a higher risk of needing retrial, regardless of what their cumulative dose was. According to Dr. Morrell, although the team did not measure acne severity, this may have contributed to the higher rates of retrial among women.
Morrell said. One of the significant problems associated with isotretinoin is the psychiatric side effects that have been observed. The results of the study revealed a very low rate of psychological symptoms, according to the authors, who note that a small number of patients had a history of psychiatric symptoms prior to the start of isotretinoin — four had issues with depression and eight had a history of other psychiatric issues, according to Dr.
The symptom survey revealed no suicidal thoughts and no documented, defined cases of clinical depression — reports of depression were typically transient. The overall presence of psychiatric symptoms was low over the course of the study patient months : 1.
Depression was typically reported at about 3. Eichenfield explained. In addition to the relationship between isotretinoin and psychiatric side effects, the study also revealed a higher rate of impaired night vision, dry, bloodshot eyes and nosebleeds among patients aged 16 to 21 years. Eichenfield noted that this is consistent with findings in other studies about isotretinoin side effects.
Eichenfield explained, adding that the higher rate of these side effects in the older pediatric patients as compared to the younger patients may have been related to the sample size.
We were pleased that our data supported the relatively good tolerance of this medicine that is so incredibly efficacious for serious acne. The survey was initiated as a consistent, standard tool for evaluating side effects that may be related to isotretinoin.
Eichenfield said. Sign in. The Dermatologist. About The Dermatologist. Meet Our Editorial Board. Meet Our Editorial Team. Advertising Inquiries. Author Guidelines. Contact Us. Current Issue. Aesthetics Corner. Allergen Focus. Board Review. Clinical Tips. Cover Story. NEA-Reviewed Content. NPF-Approved Content. NRS-Approved Content. The Dermatopathologist. Biological Pathways. Clinical Updates. Dermatology Advances. FDA Alerts. How I Treat.
Sponsored Content. Atopic Dermatitis. Hair and Trichology. Hidradenitis Suppurativa. Infectious Dermatology. Pediatric Dermatology.
Practice Advances. Professional Development. Psoriatic Arthritis. Skin Cancer. Skin of Color. Fall Dermatology Week Dermatology Week AAD Annual Meeting. SDPA Fall. Copied to clipboard. Submit Feedback. Email Address. Popular Articles.
Acne vulgaris is a ubiquitous disease, and its potential to cause significant psychological repercussions was first described over 55 years ago. Acne vulgaris is a ubiquitous The Need for a Dermatology Shelf Exam. Medical school and residency applications will never be the same. Within the past few months, two major events have upended decades-long norms in medical education.
First, the United States Medical Licensing Pigmentary Changes Associated with Skin Aging. The pigmentary system is modified by the aging process and uneven pigmentation is one of the major changes associated with aging.
This article reviews the clinical, histological and ultrastructural changes of the pigmentary system that are The pigmentary system is Management of Nodules Post-Filler Injection. This case discusses the effective management of a nodule following injection of a filler. This case discusses the What Caused These Bluish Bumps? A year-old man was brought to Latest Quizzes and Trivia.
Which treatment improved health-related quality of life, fatigue, pain, and work productivity in adults with active psoriatic arthritis? Which treatment improved Which of the following procedures have a heightened risk of infection in hidradenitis suppurativa skin lesions?
Take the quiz! Which of the following Trivia: Mental Health in Atopic Dermatitis. Trivia: Tildrakizumab's Durability and Safety. True or False: There are more adverse events and serious adverse events occurred with tildrakizumab than with placebo.
True or False: There are more According to a study published in the British Journal of General Practice, children with eczema and their parents evaluate emollients based on different aspects. What is the emollient that is suitable for everyone? According to a study published
This review suggests that isotretinoin is effective in reducing acne lesion counts, but adverse events are common. This study was registered with PROSPERO. Two recent studies examine the safety and efficacy of this acne treatment. The first, from researchers at NorthShore University Health System in Evanston. Isotretinoin use has declined in recent years but considerable caution is needed in its Isotretinoin treatment studies in acne patients. The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared. This review suggests that isotretinoin is effective in reducing acne lesion counts, but adverse events are common. This study was registered with PROSPERO. Advertising Inquiries. In addition to the relationship between isotretinoin and psychiatric side effects, the study also revealed a higher rate of impaired night vision, dry, bloodshot eyes and nosebleeds among patients aged 16 to 21 years. The traditional treatment course for severe acne consists of once to twice daily dosing 0. But inthe Food and Drug Administration issued a warning to doctors regarding a possible association with depression, psychosis, suicidal ideation, and suicide. NEA-Reviewed Content. Hair and Trichology. Detailed Description:.Study record managers: refer to the Data Element Definitions if submitting registration or results information. In current Dermatology practice, options for moderate acne vulgaris remain limited. Moderate acne is clinically defined as acne that has not responded to at least three months of topical therapy and is not severe enough for initial treatment with a conventional course of isotretinoin formerly known as Accutane.
The mainstay of treatment for moderate acne remains long courses of oral antibiotics, mainly tetracyclines doxycycline, minocycline and occasionally trimethoprim-sulfamethoxazole. Males with moderate acne, in particular, are especially limited in their treatment options as they are not eligible for hormonal management spironolactone, oral contraceptive pills like their female counterparts.
Additionally, even for those regardless of gender who may eventually qualify for a traditional isotretinoin course, many insurance companies first require failure to respond to at least three months of oral antibiotics. Nagler et. Because of this, there is a significant need for more research on alternative treatment options for moderate acne. Once weekly isotretinoin dosing has the potential to significantly improve moderate acne with good patient satisfaction and safety profile; however, no study findings on this treatment option have been published to date.
The efficacy of isotretinoin, an oral vitamin A derivative, for treatment of acne has been well established. The traditional treatment course for severe acne consists of once to twice daily dosing 0. Though efficacious, there are numerous reported side-effects due to achieving the cumulative dose rapidly by once to twice daily dosing, such as severe dry skin, lips, and eyes, as well as liver enzyme and lipid abnormalities.
Because of this, there have been studies exploring alternative isotretinoin dosing regimens including microdose, lower daily dose regimens 0. Those who also analyzed adverse effect rates with alternative isotretinoin dosing found that these were either rarely observed or similar to conventional dosing. Interestingly, rates of acne recurrence between alternative isotretinoin dosing and conventional dosing were similar at follow-up,6,7,9 despite a much older study from that found otherwise.
Secondary endpoints include patient satisfaction and adverse effects. Participants are eligible for the study if their score is 3 or higher. An improvement in their visible acne is a score of 2, 1, or 0 at the end of the 4 months of treatment.
Secondary Outcome Measures : Number of Participants With a Change in Quality of Life [ Time Frame: Baseline, monthly, and end of treatment, total of 4 months ] Participants will use the Dermatology Life Quality Index survey which measures how much their skin problems affect their life.
The higher the score the more their skin impacts their day to day activities. An improvement in their quality of life is a lower score at 4 months compared to baseline score.
Number of Side Effects Reported at the End of 4 Months [ Time Frame: through study completion, an average of 4 months ] Participants will fill out a survey regarding nonserious and serious adverse events.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Weekly Isotretinoin Therapy Study WIT The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : May 9, Last Update Posted : May 9, Study Description. The mainstay of treatment for moderate acne remains long courses of oral antibiotics despite emerging antibiotic resistance. The efficacy of daily to twice daily dosed isotretinoin, an oral vitamin A derivative, for treatment of severe acne has been well established.
The purpose of this study is to determine if once weekly dosed isotretinoin is effective for the treatment of patients with moderate acne. Additionally, the study aims to evaluate patient satisfaction and identify any adverse effects on this alternative dosing regimen.
Detailed Description:. Drug Information available for: Isotretinoin. FDA Resources. Arms and Interventions. Outcome Measures. Participants will fill out a survey regarding nonserious and serious adverse events. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. The use of oral antibiotics before isotretinoin therapy in patients with acne. J Am Acad Dermatol. Epub Oct Antibiotic stewardship in dermatology: limiting antibiotic use in acne.
Eur J Dermatol. Bowe WP. Antibiotic resistance and acne: where we stand and what the future holds. J Drugs Dermatol. Antibiotic-resistant acne: lessons from Europe. Br J Dermatol. Low-dose schema of isotretinoin in acne vulgaris. Int J Clin Pharmacol Res. Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study.
Epub May Low-dose isotretinoin in the treatment of acne vulgaris. Kotori MG. Med Arch. Epub Feb Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled, randomized double-blind study. J Eur Acad Dermatol Venereol. Epub Apr Efficacy of fixed low-dose isotretinoin 20 mg, alternate days with topical clindamycin gel in moderately severe acne vulgaris.
Epub Jan 9. Treatment of acne with intermittent and conventional isotretinoin: a randomized, controlled multicenter study. Arch Dermatol Res. Epub Aug Treatment of acne with intermittent isotretinoin. Kaymak Y, Ilter N.
The effectiveness of intermittent isotretinoin treatment in mild or moderate acne. Isotretinoin therapy for acne: results of a multicenter dose-response study. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Acne Vulgaris. Drug: Isotretinoin. Phase 1 Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :.
The study member assessing change in acne using the Comprehensive Acne Severity Scale does not know the medication the participants are taking. Actual Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Drug: Isotretinoin Participants will be getting isotretinoin
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