drugset / Trial / NCT04594759
Weekly Isotretinoin Therapy Study
Non-randomizedSingle-groupOpen-labelTreatment
Summary
In current Dermatology practice, options for moderate acne vulgaris remain limited. 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.
Timeline
- Start
- 2020-11-11
- Primary completion
- 2021-12-21
- Completion
- 2021-12-21
Publications
- Background Nagler AR, Milam EC, Orlow SJ. The use of oral antibiotics before isotretinoin therapy in patients with acne. J Am Acad Dermatol. 2016 Feb;74(2):273-9. doi: 10.1016/j.jaad.2015.09.046. Epub 2015 Oct 30.
- Background Center for Disease Control (https://www.cdc.gov/drugresistance/biggest-threats.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fdrugresistance%2Fbiggest_threats.html)
- Background Dreno B, Thiboutot D, Gollnick H, Bettoli V, Kang S, Leyden JJ, Shalita A, Torres V; Global Alliance to Improve Outcomes in Acne. Antibiotic stewardship in dermatology: limiting antibiotic use in acne. Eur J Dermatol. 2014 May-Jun;24(3):330-4. doi: 10.1684/ejd.2014.2309.
- Background Bowe WP. Antibiotic resistance and acne: where we stand and what the future holds. J Drugs Dermatol. 2014 Jun;13(6):s66-70.
- Background Ross JI, Snelling AM, Carnegie E, Coates P, Cunliffe WJ, Bettoli V, Tosti G, Katsambas A, Galvan Perez Del Pulgar JI, Rollman O, Torok L, Eady EA, Cove JH. Antibiotic-resistant acne: lessons from Europe. Br J Dermatol. 2003 Mar;148(3):467-78. doi: 10.1046/j.1365-2133.2003.05067.x.
- Background Mandekou-Lefaki I, Delli F, Teknetzis A, Euthimiadou R, Karakatsanis G. Low-dose schema of isotretinoin in acne vulgaris. Int J Clin Pharmacol Res. 2003;23(2-3):41-6.
- Background Lee JW, Yoo KH, Park KY, Han TY, Li K, Seo SJ, Hong CK. Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study. Br J Dermatol. 2011 Jun;164(6):1369-75. doi: 10.1111/j.1365-2133.2010.10152.x. Epub 2011 May 17.
- Background Amichai B, Shemer A, Grunwald MH. Low-dose isotretinoin in the treatment of acne vulgaris. J Am Acad Dermatol. 2006 Apr;54(4):644-6. doi: 10.1016/j.jaad.2005.11.1061.
- Background Kotori MG. Low-dose Vitamin "A" Tablets-treatment of Acne Vulgaris. Med Arch. 2015 Feb;69(1):28-30. doi: 10.5455/medarh.2015.69.28-30. Epub 2015 Feb 21.
- Background Rademaker M, Wishart JM, Birchall NM. Isotretinoin 5 mg daily for low-grade adult acne vulgaris--a placebo-controlled, randomized double-blind study. J Eur Acad Dermatol Venereol. 2014 Jun;28(6):747-54. doi: 10.1111/jdv.12170. Epub 2013 Apr 26.
- Background Sardana K, Garg VK, Sehgal VN, Mahajan S, Bhushan P. Efficacy of fixed low-dose isotretinoin (20 mg, alternate days) with topical clindamycin gel in moderately severe acne vulgaris. J Eur Acad Dermatol Venereol. 2009 May;23(5):556-60. doi: 10.1111/j.1468-3083.2008.03022.x. Epub 2009 Jan 9.
- Background Akman A, Durusoy C, Senturk M, Koc CK, Soyturk D, Alpsoy E. Treatment of acne with intermittent and conventional isotretinoin: a randomized, controlled multicenter study. Arch Dermatol Res. 2007 Dec;299(10):467-73. doi: 10.1007/s00403-007-0777-2. Epub 2007 Aug 21.
- Background Goulden V, Clark SM, McGeown C, Cunliffe WJ. Treatment of acne with intermittent isotretinoin. Br J Dermatol. 1997 Jul;137(1):106-8.
- Background Kaymak Y, Ilter N. The effectiveness of intermittent isotretinoin treatment in mild or moderate acne. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1256-60. doi: 10.1111/j.1468-3083.2006.01784.x.
- Background Strauss JS, Rapini RP, Shalita AR, Konecky E, Pochi PE, Comite H, Exner JH. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol. 1984 Mar;10(3):490-6. doi: 10.1016/s0190-9622(84)80100-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isotretinoin | Other / unclassified | 1 mg/kg | Oral |
| Subject | Isotretinoin | Other / unclassified | 1.5 mg/kg | Oral |