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NCT Number: NCT07544251

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

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.

Recruiting

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Key information

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Integrative Research Institute

Sacramento, California, 95819, United States

Location status: Recruiting

Location contact

Nasima Afzal Chief Operating Officer

CONTACT

[email protected]

209-607-8778

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
  • Individuals who are pregnant or breastfeeding.
  • Individuals on oral contraceptive pills or progesterone or estrogen containing therapies unless they have been on a stable dose for 2 months.
  • Individuals on finasteride or dutasteride
  • Current tobacco smoker or a tobacco smoking history that is greater than 5 pack-years.

Treatment and study plan

Sarecycline

Drug

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)

Doxycycline

Drug

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

Primary outcomes

  1. 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.

    Assessing change in the relative abundance of tetracycline resistant bacteria in the gut microbiome following treatment.

  2. Change in the relative abundance of fungi/yeast in the gut microbiome

    Time frame: From enrollment to the end of treatment at 4 weeks.

    Assessing change in the relative abundance of fungi/yeast in the gut microbiome following treatment.

Secondary outcomes

  1. Change in inflammatory and non-inflammatory lesions

    Time frame: From enrollment to the end of treatment at 4 weeks.

    Assesing change in inflammatory and non-inflammatory lesions.

  2. Change in the diversity of the gut microbiome: Shannon Diversity

    Time frame: From enrollment to the end of treatment at 4 weeks.

    Assessing the change in Alpha Diversity of the gut microbiome via Shannon Diversity

  3. Change in investigator global assessment of acne

    Time frame: From enrollment to the end of treatment at 4 weeks.

    Change in investigator global assessment of acne

  4. Change in relative abundance of short chain fatty acid production genes

    Time frame: From enrollment to the end of treatment at 4 weeks.

    Assessing change in relative abundance of short chain fatty acid production genes upon gut microbiome analysis.

  5. Change in skin microbiome relative abundance

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Assessing change in the relative abundance of the skin microbiome via Shannon Diversity.

  6. Change in the skin microbiome relative abundance of fungi/yeast

    Time frame: From enrollement to the end of treatment at 4 weeks.

    Assessing change in the relative abundance of fungi/yeast in the skin microbiome.

Study contacts

Contact information is provided by the study sponsor or research team.

Nasima Afzal Chief Operating Officer

CONTACT

[email protected]

916-775-5080

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Almirall, S.A.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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