Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.

Official title

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

Overview

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.

Interventions

• 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)
• Drug Doxycycline
  100 mg twice daily with food and a full glass of water (about 8 ounces)

Primary outcome measures

• Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome [Time frame: From enrollment to the end of treatment at 4 weeks.]
• Change in the relative abundance of fungi/yeast in the gut microbiome [Time frame: From enrollment to the end of treatment at 4 weeks.]

Secondary outcome measures (6)

• Change in inflammatory and non-inflammatory lesions [Time frame: From enrollment to the end of treatment at 4 weeks.]
• Change in the diversity of the gut microbiome: Shannon Diversity [Time frame: From enrollment to the end of treatment at 4 weeks.]
• Change in investigator global assessment of acne [Time frame: From enrollment to the end of treatment at 4 weeks.]
• Change in relative abundance of short chain fatty acid production genes [Time frame: From enrollment to the end of treatment at 4 weeks.]
• Change in skin microbiome relative abundance [Time frame: From enrollment to the end of treatment at 8 weeks.]
• Change in the skin microbiome relative abundance of fungi/yeast [Time frame: From enrollement to the end of treatment at 4 weeks.]

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

• Dermatological condition of face or facial hair that could interfere with clinical evaluations
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Integrative Research Institute — Sacramento

Identifiers

NCT: NCT07544251 · IRI26_02_SarecyclinevsDoxy

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗