Acne VulgarisPhase 4NCT07544251
Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.
A Phase 4 study testing Sarecycline and Doxycycline in people with Acne Vulgaris, run by Integrative Skin Science and Research at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sarecycline and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Integrative Research Institute
Sacramento, California, 95819
Nasima Afzal Chief Operating Officer, 209-607-8778, nasima@integrativeskinresearch.com
About this study
Official title: The Effects of Sarecycline Versus Doxycycline on the Gut Microbiome and Skin Microbiome 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.
- Conditions
- Acne Vulgaris
- Being tested
- Sarecycline, Doxycycline
- Keywords
- Acne Vulgaris, Sarecycline, Doxycycline, Microbiome
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarecyclineDrug
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)
DoxycyclineDrug
100 mg twice daily with food and a full glass of water (about 8 ounces)
| Study group | Role | What they receive |
|---|---|---|
| Sarecycline Group | Experimental | Half of the participants will be randomized to receive sarecycline treatment. Receives: Drug: Sarecycline |
| Doxycycline Group | Experimental | Half of the participants will be randomized to receive doxycycline treatment. Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 4 weeks.
Secondary outcomes (6)
Change in inflammatory and non-inflammatory lesions
Assesing change in inflammatory and non-inflammatory lesions.
Measured: From enrollment to the end of treatment at 4 weeks.
Change in the diversity of the gut microbiome: Shannon Diversity
Assessing the change in Alpha Diversity of the gut microbiome via Shannon Diversity
Measured: From enrollment to the end of treatment at 4 weeks.
Change in investigator global assessment of acne
Change in investigator global assessment of acne
Measured: From enrollment to the end of treatment at 4 weeks.
Change in relative abundance of short chain fatty acid production genes
Assessing change in relative abundance of short chain fatty acid production genes upon gut microbiome analysis.
Measured: From enrollment to the end of treatment at 4 weeks.
Change in skin microbiome relative abundance
Assessing change in the relative abundance of the skin microbiome via Shannon Diversity.
Measured: From enrollment to the end of treatment at 8 weeks.
Change in the skin microbiome relative abundance of fungi/yeast
Assessing change in the relative abundance of fungi/yeast in the skin microbiome.
Measured: From enrollement to the end of treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almirall, S.A.
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544251
- Sponsor's protocol ID
- IRI26_02_SarecyclinevsDoxy
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sarecycline Versus Doxycycline on the Gut Microbiome and Skin Microbiome in Acne.
- ClinicalTrials.gov ID
- NCT07544251
- Acronym / sponsor ID
- IRI26_02_SarecyclinevsDoxy
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Sarecycline, Doxycycline, Microbiome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Almirall, S.A.
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sarecycline Group | Experimental | Drug: SarecyclineHalf of the participants will be randomized to receive sarecycline treatment. |
| Doxycycline Group | Experimental | Drug: DoxycyclineHalf of the participants will be randomized to receive doxycycline treatment. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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:
- Topical acne medications such as retinoids, antibiotics, hormonal modulators
- Topical benzoyl peroxide
- Topical anti-inflammatories and corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SarecyclineOne 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 | Sarecycline Group |
| Doxycycline100 mg twice daily with food and a full glass of water (about 8 ounces) | Drug | Doxycycline Group |
Primary outcome
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.
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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raja Sivamani, MD principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sarecycline and Doxycycline in people with Acne Vulgaris, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nasima Afzal Chief Operating Officer (916-775-5080, nasima@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.