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 receivedsubantimicrobial, 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.
RCT Entities:
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.
Authors: Enrico Carmina; Brigitte Dreno; W Anne Lucky; W George Agak; Anuja Dokras; Jin Ju Kim; Rogerio A Lobo; Fahimeh Ramezani Tehrani; Daniel Dumesic Journal: J Endocr Soc Date: 2022-02-06