Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
Purpose
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.
Condition
- Acne Vulgaris
Eligibility
- Eligible Ages
- Over 9 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- ) 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
- 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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized into two groups, each group receiving a different oral antibiotics ( sarecycline or doxycycline). Changes in relative abundance of tetracycline resistant bacteria will be assessed and compared among the two groups over the course of four weeks.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sarecycline Group |
Half of the participants will be randomized to receive sarecycline treatment. |
|
|
Experimental Doxycycline Group |
Half of the participants will be randomized to receive doxycycline treatment. |
|
Recruiting Locations
Integrative Research Institute
Sacramento, California 95819
Sacramento, California 95819
More Details
- Status
- Recruiting
- Sponsor
- Integrative Skin Science and Research