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

NCT07544251 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRI26_02_SarecyclinevsDoxy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Acne Vulgaris; Sarecycline; Doxycycline; Microbiome

Outcome Measures

Primary Outcomes (2)

• Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome

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

  From enrollment to the end of treatment at 4 weeks.

• Change in the relative abundance of fungi/yeast in the gut microbiome

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

  From enrollment to the end of treatment at 4 weeks.

Secondary Outcomes (6)

• Change in inflammatory and non-inflammatory lesions

  From enrollment to the end of treatment at 4 weeks.

• Change in the diversity of the gut microbiome: Shannon Diversity

  From enrollment to the end of treatment at 4 weeks.

• Change in investigator global assessment of acne

  From enrollment to the end of treatment at 4 weeks.

• Change in relative abundance of short chain fatty acid production genes

  From enrollment to the end of treatment at 4 weeks.

• Change in skin microbiome relative abundance

  From enrollment to the end of treatment at 8 weeks.

Study Arms (2)

Sarecycline Group

EXPERIMENTAL

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

Drug: Sarecycline

Doxycycline Group

EXPERIMENTAL

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

Drug: Doxycycline

Interventions

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)

Sarecycline Group

Doxycycline DRUG

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

Doxycycline Group

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• 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:
• a) Within 2 week prior to randomization:
• Topical acne medications such as retinoids, antibiotics, hormonal modulators
• Topical benzoyl peroxide
• Topical anti-inflammatories and corticosteroids
• b) Within 4 weeks prior to randomization:
• Systemic antibiotics
• Systemic acne treatments
• Oral probiotic supplement
• Systemic corticosteroids
• c) 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Almirall, S.A.: collaborator

Study Sites (1)

Integrative Research Institute

Sacramento, California, 95819, United States

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

sarecycline; Doxycycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Raja Sivamani, MD

  Integrative Skin Science and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasima Afzal Chief Operating Officer

CONTACT

916-775-5080; nasima@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into two groups, each group receiving a different oral antibiotics ( sarecycline or doxycycline). Changes in relative abundance of tetracycline resistant bacteria will be assessed and compared among the two groups over the course of four weeks.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)