Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
ConditionAcne Vulgaris
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age9+
SponsorIntegrative Skin Science and Research
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Dermatological condition of face or facial hair that could interfere with clinical evaluations
Topical acne medications such as retinoids, antibiotics, hormonal modulators
Topical benzoyl peroxide
Topical anti-inflammatories and corticosteroids
Trial design
Design model
Parallel
Treatments tested in this trial
Sarecycline
DrugOne tablet by mouth (weight based dosing at 1.5 mg/kg 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)
Doxycycline
Drug100 mg twice daily with food and a full glass of water (about 8 ounces)
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Sarecycline GroupExperimental treatment 1 intervention
Group B: Doxycycline GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 4 weeks.2
Change in the relative abundance of fungi/yeast in the gut microbiome
Assessing change in the relative abundance of fungi/yeast in the gut microbiome following treatment.
Time frame
From enrollment to the end of treatment at 4 weeks.Secondary outcomes
1
Change in inflammatory and non-inflammatory lesions
Assesing change in inflammatory and non-inflammatory lesions.
Time frame
From enrollment to the end of treatment at 4 weeks.2
Change in the diversity of the gut microbiome: Shannon Diversity
Assessing the change in Alpha Diversity of the gut microbiome via Shannon Diversity
Time frame
From enrollment to the end of treatment at 4 weeks.3
Change in investigator global assessment of acne
Change in investigator global assessment of acne
Time frame
From enrollment to the end of treatment at 4 weeks.4
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.
Time frame
From enrollment to the end of treatment at 4 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Integrative Skin Science and Research
Lead sponsor
Almirall, S.A.
Collaborator
Source ClinicalTrials.gov