Sarecycline versus doxycycline effects on skin and gut bacteria in acne

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with acne vulgaris who meet lesion-count criteria will receive either sarecycline or doxycycline in this Phase 4 interventional study. Skin swabs and stool samples will be collected at baseline and during treatment to profile bacterial communities on the skin and in the gut. Microbiome sequencing and comparative analyses will be used to see how each antibiotic changes bacterial composition and diversity over time. The study excludes participants with recent use of specified topical or systemic acne therapies, probiotics, or systemic retinoids to limit confounding.

Why it matters

Who can join: the full rules

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.

Where it's running

• Integrative Research Institute
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Raja Sivamani, MD — Integrative Skin Science and Research
• Study coordinator: Nasima Afzal Chief Operating Officer
• Email: nasima@integrativeskinresearch.com
• Phone: 916-775-5080

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.