Sarecycline versus doxycycline effects on skin and gut bacteria in acne

The Effects of Sarecycline Versus Doxycycline on the Gut Microbiome and Skin Microbiome in Acne.

We will test whether treating people with acne using sarecycline or doxycycline causes different changes in the bacteria on the skin and in the gut.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 9 Years and up
• Sex: All
• Sponsor: Integrative Skin Science and Research (Industry-sponsored)
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT07544251 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People with acne vulgaris who have at least 10 inflammatory lesions and up to 100 noninflammatory lesions (and no more than 2 facial nodules) who meet the medication washout requirements are ideal candidates.

Not a fit: Individuals with other facial dermatologic conditions, recent use of systemic antibiotics, systemic retinoids, oral probiotics, or recent changes to hormonal therapies are unlikely to benefit or be eligible to participate.

Why it matters

Potential benefit: If successful, results could help clinicians choose an acne antibiotic that causes fewer harmful changes to the skin or gut microbiome.

How similar studies have performed: Prior research shows tetracycline-class antibiotics alter skin and gut microbiomes and smaller studies suggest sarecycline may have a narrower microbiome impact, but direct comparative data remain limited.

Eligibility criteria

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 this trial is running

Sacramento, California

• 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

Conditions Acne Vulgaris; Sarecycline; Doxycycline; Microbiome