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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

Eligibility

Eligible Ages
Over 9 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

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

ArmDescriptionAssigned Intervention
Experimental
Sarecycline Group 		Half of the participants will be randomized to receive sarecycline treatment.
  • Drug: 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)
Experimental
Doxycycline Group 		Half of the participants will be randomized to receive doxycycline treatment.
  • Drug: Doxycycline
    100 mg twice daily with food and a full glass of water (about 8 ounces)

Recruiting Locations

Integrative Research Institute
Sacramento, California 95819
Contact:
Nasima Afzal Chief Operating Officer
209-607-8778
nasima@integrativeskinresearch.com

More Details

Status
Recruiting
Sponsor
Integrative Skin Science and Research

Study Contact

Nasima Afzal Chief Operating Officer
916-775-5080
nasima@integrativeskinresearch.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.