Recruiting

Sarecycline & Doxycycline

Sponsor:

Integrative Skin Science and Research

Code:

NCT07544251

Conditions

Acne Vulgaris

Eligibility Criteria

Sex: All

Age: 9+

Healthy Volunteers: Accepted

Interventions

Sarecycline

Doxycycline

Study Details

Brief summary:

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.

Conditions

Acne Vulgaris

Study ID

NCT07544251

Start date

Apr 20, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sarecycline Group

Half of the participants will be randomized to receive sarecycline treatment.

experimental: Doxycycline Group

Half of the participants will be randomized to receive doxycycline treatment.

Interventions

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)

Doxycycline

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Nasima Afzal Chief Operating Officer

916-775-5080nasima@integrativeskinresearch.com

Locations

Integrative Research Institute

Recruiting

Sacramento, California, United States, 95819

Contacts

Nasima Afzal Chief Operating Officer

209-607-8778nasima@integrativeskinresearch.com

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Acne Vulgaris
  • Sarecycline
  • Doxycycline
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2026-04-22.