[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07544251":3,"trial-entities:NCT07544251":115,"trial-summary:NCT07544251":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":49,"sex":69,"minimum_age":70,"maximum_age":17,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":86,"locations":90,"central_contacts":106,"overall_officials":109,"references":113,"see_also_links":114},"NCT07544251","IRI26_02_SarecyclinevsDoxy","Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.","The Effects of Sarecycline Versus Doxycycline on the Gut Microbiome and Skin Microbiome in Acne.","RECRUITING","2027-06","2026-04","2026-04-22","2026-04-20","Integrative Skin Science and Research","INDUSTRY",false,"This study is being done to help better understand how the gut and skin bacteria of the body change when people with acne are treated with Sarecycline or Doxycycline. The bacteria in the gut and on the skin will be studied to see how each treatment may affect them and whether they change the profile of the bacteria that is present.",null,[19],"Acne Vulgaris",[19,21,22,23],"Sarecycline","Doxycycline","Microbiome","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},30,"ESTIMATED",[32,37],{"type":33,"name":21,"description":34,"armGroupLabels":35},"DRUG","One tablet by mouth (weight based dosing at 1.5 mg\u002Fkg and rounded to the closest tablet dose at either 60 mg, 100mg, or 150 mg tablet) once a day with food and a full glass of water (about 8 ounces)",[36],"Sarecycline Group",{"type":33,"name":22,"description":38,"armGroupLabels":39},"100 mg twice daily with food and a full glass of water (about 8 ounces)",[40],"Doxycycline Group",[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome","Assessing change in the relative abundance of tetracycline resistant bacteria in the gut microbiome following treatment.","From enrollment to the end of treatment at 4 weeks.",{"measure":47,"description":48,"timeFrame":45},"Change in the relative abundance of fungi\u002Fyeast in the gut microbiome","Assessing change in the relative abundance of fungi\u002Fyeast in the gut microbiome following treatment.",[50,53,56,58,61,65],{"measure":51,"description":52,"timeFrame":45},"Change in inflammatory and non-inflammatory lesions","Assesing change in inflammatory and non-inflammatory lesions.",{"measure":54,"description":55,"timeFrame":45},"Change in the diversity of the gut microbiome: Shannon Diversity","Assessing the change in Alpha Diversity of the gut microbiome via Shannon Diversity",{"measure":57,"description":57,"timeFrame":45},"Change in investigator global assessment of acne",{"measure":59,"description":60,"timeFrame":45},"Change in relative abundance of short chain fatty acid production genes","Assessing change in relative abundance of short chain fatty acid production genes upon gut microbiome analysis.",{"measure":62,"description":63,"timeFrame":64},"Change in skin microbiome relative abundance","Assessing change in the relative abundance of the skin microbiome via Shannon Diversity.","From enrollment to the end of treatment at 8 weeks.",{"measure":66,"description":67,"timeFrame":68},"Change in the skin microbiome relative abundance of fungi\u002Fyeast","Assessing change in the relative abundance of fungi\u002Fyeast in the skin microbiome.","From enrollement to the end of treatment at 4 weeks.","ALL","9 Years",true,{"inclusion":73,"exclusion":76,"raw_text":85},[74,75],"At least 10 inflammatory lesions (papules, pustules, and nodules) up to 100 noninflammatory lesions (open and closed comedones)","No more than 2 nodules on the face",[77,78,79,80,81,82,83,84],"Topical acne medications such as retinoids, antibiotics, hormonal modulators","Topical benzoyl peroxide","Topical anti-inflammatories and corticosteroids","Systemic antibiotics","Systemic acne treatments","Oral probiotic supplement","Systemic corticosteroids","Systemic retinoids","Inclusion Criteria:\n\n1\\) Diagnosis of acne vulgaris with:\n\n* At least 10 inflammatory lesions (papules, pustules, and nodules) up to 100 noninflammatory lesions (open and closed comedones)\n* No more than 2 nodules on the face\n\nExclusion Criteria:\n\n1. Dermatological condition of face or facial hair that could interfere with clinical evaluations\n2. Subjects who have used the following medications (topical refers only to the facial area) will not be eligible:\n\n2a) Within 2 week prior to randomization:\n\n* Topical acne medications such as retinoids, antibiotics, hormonal modulators\n* Topical benzoyl peroxide\n* Topical anti-inflammatories and corticosteroids\n\n  2b) Within 4 weeks prior to randomization:\n* Systemic antibiotics\n* Systemic acne treatments\n* Oral probiotic supplement\n* Systemic corticosteroids\n\n  2c) Within 12 weeks prior to randomization:\n* Systemic retinoids\n\n  3\\) Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.\n\n  4\\) Individuals who are pregnant or breastfeeding.\n\n  5\\) Individuals on oral contraceptive pills or progesterone or estrogen containing therapies unless they have been on a stable dose for 2 months.\n\n  6\\) Individuals on finasteride or dutasteride\n\n  7\\) Current tobacco smoker or a tobacco smoking history that is greater than 5 pack-years.",[87,88,89],"CHILD","ADULT","OLDER_ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"Integrative Research Institute","Sacramento","California","95819","United States",[98],{"name":99,"role":100,"phone":101,"email":102},"Nasima Afzal Chief Operating Officer","CONTACT","209-607-8778","nasima@integrativeskinresearch.com",{"lat":104,"lon":105},38.58157,-121.4944,[107],{"name":99,"role":100,"phone":108,"email":102},"916-775-5080",[110],{"name":111,"affiliation":13,"role":112},"Raja Sivamani, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Acne",[],{"nct_id":4,"found":71,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This study is an interventional trial planning to enroll 30 participants. It compares the effects of Sarecycline and Doxycycline.","completed","Comparing Sarecycline and Doxycycline for Acne and Gut Bacteria","This study is looking at how two common acne medications, Sarecycline and Doxycycline, affect the bacteria in your gut and on your skin. Researchers want to understand if these treatments change the types of bacteria present. You may be able to join if you have acne vulgaris with at least 10 inflammatory lesions (red bumps or pimples) and no more than 2 nodules (larger, deeper bumps) on your face. The study will measure changes in specific bacteria in your gut after 4 weeks of treatment. The current recruitment status is unclear, but the study plans to enroll 30 participants.","Participants will be followed from enrollment to the end of treatment at 4 weeks.",99,"You would take either Sarecycline or Doxycycline by mouth once or twice a day with food and water. The study will involve measurements of your gut bacteria from enrollment to the end of treatment at 4 weeks.","Not stated in the trial record.",[21,22],"v2"]