Sarecycline: One 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: 100 mg twice daily with food and a full glass of water (about 8 ounces)
Study summary
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
Sex
ALL
Min age
9 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1\) Diagnosis of acne vulgaris with:
* 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
Exclusion Criteria:
1. Dermatological condition of face or facial hair that could interfere with clinical evaluations
2. Subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
2a) Within 2 week prior to randomization:
* Topical acne medications such as retinoids, antibiotics, hormonal modulators
* Topical benzoyl peroxide
* Topical anti-inflammatories and corticosteroids
2b) Within 4 weeks prior to randomization:
* Systemic antibiotics
* Systemic acne treatments
* Oral probiotic supplement
* Systemic corticosteroids
2c) Within 12 weeks prior to randomization:
* Systemic retinoids
3\) Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
4\) Individuals who are pregnant or breastfeeding.
5\) Individuals on oral contraceptive pills or progesterone or estrogen containing therapies unless they have been on a stable dose for 2 months.
6\) Individuals on finasteride or dutasteride
7\) Current tobacco smoker or a tobacco smoking history that is greater than 5 pack-years.
Primary outcome measure(s)
Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome — From enrollment to the end of treatment at 4 weeks. Assessing change in the relative abundance of tetracycline resistant bacteria in the gut microbiome following treatment.
Change in the relative abundance of fungi/yeast in the gut microbiome — From enrollment to the end of treatment at 4 weeks. Assessing change in the relative abundance of fungi/yeast in the gut microbiome following treatment.
Trial sites (1)
Facility
City
Region
Status
Integrative Research Institute
Sacramento
California
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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