The Effects of Sarecycline Versus Doxycycline on the Gut Microbiome and Skin Microbiome in Acne

What this Trial Is About

Researchers are studying how the bacteria in the gut and on the skin change in people with acne vulgaris when treated with either Sarecycline or Doxycycline. This trial aims to compare the effects of these two medications on the bacteria profiles and understand how each treatment may influence the presence of different bacteria types, including resistant bacteria and fungi. The study is a Phase 4, randomized clinical trial involving individuals with acne vulgaris who have a defined number of inflammatory and non-inflammatory lesions. Participants will be randomly assigned to one of two groups: one group will receive Sarecycline tablets once daily, with the dose based on body weight (60 mg, 100 mg, or 150 mg), while the other group will receive Doxycycline at 100 mg twice daily. Both medications are taken with food and a full glass of water. Treatment and observation last for 4 to 8 weeks, with specific measurements taken at the end of this period to evaluate changes in the bacteria and fungi on the skin and in the gut. During the study, participants will be monitored for changes in the types and amounts of bacteria and fungi present in their gut and skin microbiomes. Researchers will assess acne severity through lesion counts and investigator evaluations. The study also tracks the presence of antibiotic-resistant bacteria and genes related to fatty acid production. The total participation time includes treatment and follow-up visits to collect samples and clinical data, ensuring comprehensive monitoring of treatment effects and safety.

Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.