PMID- 26091383 OWN - NLM STAT- MEDLINE DCOM- 20160408 LR - 20150620 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 14 IP - 6 DP - 2015 Jun TI - Efficacy and Safety of Subantimicrobial Dose, Modified-Release Doxycycline 40 mg Versus Doxycycline 100 mg Versus Placebo for the treatment of Inflammatory Lesions in Moderate and Severe Acne: A Randomized, Double-Blinded, Controlled Study. PG - 581-6 AB - INTRODUCTION: Routine use of doxycycline (DC) 100 mg for the treatment of moderate to severe acne may be associated with gastrointestinal adverse events (AEs), thus potentially impacting patient adherence, and antibiotic resistance. This study evaluated the safety and efficacy of subantimicrobial, modified-release (MR) DC 40 mg compared to DC 100 mg and to placebo for the treatment of inflammatory lesions in moderate and severe acne. METHODS: 662 subjects aged 12 years or older with moderate to severe acne received subantimicrobial, MR-DC 40 mg tablets, DC 100 mg capsules, or placebo once daily for 16 weeks. RESULTS: MR-DC 40 mg was superior to placebo in the mean reduction of the number of inflammatory lesions, median percent reduction in inflammatory and total lesions, and success rate. MR-DC 40 mg was also comparable to DC 100 mg in the reduction of the number of inflammatory lesions, and percent reduction of total lesions. Incidence of drug-related AEs for MR-DC 40 mg was similar to placebo and was markedly smaller compared to DC 100 mg. DISCUSSION: MR-DC 40 mg demonstrated comparable efficacy and superior safety to DC 100 mg in the treatment of moderate to severe inflammatory acne. FAU - Moore, Angela AU - Moore A FAU - Ling, Mark AU - Ling M FAU - Bucko, Alicia AU - Bucko A FAU - Manna, Vasant AU - Manna V FAU - Rueda, Marie-Jose AU - Rueda MJ LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 RN - 0 (Anti-Infective Agents) RN - 0 (Delayed-Action Preparations) RN - N12000U13O (Doxycycline) SB - IM MH - Acne Vulgaris/*drug therapy MH - Adolescent MH - Adult MH - Aged MH - Anti-Infective Agents/administration & dosage/adverse effects/*therapeutic use MH - Child MH - Delayed-Action Preparations MH - Double-Blind Method MH - Doxycycline/administration & dosage/adverse effects/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Treatment Outcome MH - Young Adult EDAT- 2015/06/20 06:00 MHDA- 2016/04/09 06:00 CRDT- 2015/06/20 06:00 PHST- 2015/06/20 06:00 [entrez] PHST- 2015/06/20 06:00 [pubmed] PHST- 2016/04/09 06:00 [medline] AID - S1545961615P0581X [pii] PST - ppublish SO - J Drugs Dermatol. 2015 Jun;14(6):581-6.