title: Safety and efficacy of fixed-dose 10 mg daily isotretinoin treatment for acne vulgaris in Malaysia.
abstract: BACKGROUND
  Low-dose isotretinoin is used to reduce side effects albeit higher relapse. This study aimed to determine the efficacy and safety of fixed-dose 10 mg daily isotretinoin for the treatment of acne.
  
  
  METHODS
  This prospective study was performed between 2011 and 2015. All 150 patients were given 10 mg daily isotretinoin until a cumulative dose of 90-110 mg/kg.
  
  
  RESULTS
  The mean age was 26.6 years with 64.7% moderate acne, 29.3% severe, and 6% very severe. The mean cumulative dose was 98.8 ± 6.05 mg/kg. All 150 patients had total clearance with a mean time to clearance of 24.0 weeks. Patients with severe/very severe acne had higher cumulative dosage (102.1 vs. 97.0, P < 0.001) and longer duration to clearance (32.9 weeks vs. 19.1 weeks, P < 0.001). Mild relapse was seen in 4%. The mean time to relapse was 32.3 weeks. Lip dryness was the commonest side effects (100%). Mild transient elevation of liver enzymes was detected in 3.3% and a slight increase of serum lipid in 2.7% with no treatment discontinuation.
  
  
  CONCLUSIONS
  Fixed-dose 10 mg daily treatment with isotretinoin until a cumulative dose of 90-110 mg/kg is safe with low relapse rate.
authors.affiliation: Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Kajang, Malaysia.
authors.forename: Felix Boon-Bin
authors.initials: FB
authors.lastname: Yap
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000378:metabolism; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage* / Q000009:adverse effects; D008055:Lipids / Q000097:blood; D008099:Liver / Q000201:enzymology; D008296:Malaysia; D008297:Male; D011446:Prospective Studies; D012008:Recurrence; D012871:Skin Diseases / Q000139:chemically induced
chemical_list: D003879:Dermatologic Agents; D008055:Lipids; D015474:Isotretinoin
keywords: acne; isotretinoin; safety