ClinicalTrials.gg
RecruitingNCT07544251Updated Apr 22, 2026

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

A Phase 4 interventional study of Sarecycline and Doxycycline in Acne Vulgaris, sponsored by Integrative Skin Science and Research. Recruiting at 1 site in United States. Open to participants aged 9 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Integrative Skin Science and Research · Phase 4, Interventional, and Treatment

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Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies testing doxycycline in Acne Vulgaris — 2 open to participants now, 3 under way, none of them phase 3. Doxycycline · Acne Vulgaris.

Planned enrollment
9th of 12
30 · median 47
Started
2026
the only one that year
Phase 4
6 of 12
1 open now
Registered
12th of 12
by date
Lead sponsor
1 of 12
Integrative Skin Science and Research

Among the 12 studies testing doxycycline in Acne Vulgaris, this one is the 9th largest by planned enrollment, is the only one that started in 2026, is one of 6 in phase 4, and was the 12th registered.

Acne Vulgaris

791 studies on the registry are indexed under Acne Vulgaris; 94 are open to participants now.

Browse Acne Vulgaris studies →

Open to participants now

2 of the 12 studies testing doxycycline in Acne Vulgaris are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

About doxycycline

Doxycycline: first FDA approval 1967 (VIBRAMYCIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 47 Acne Vulgaris studies recruiting now, 17 (36%) set no upper age limit and 29 (62%) stop at 75 or younger; 21 take children under 18; 17 take healthy volunteers.

This study: 9 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies testing doxycycline in Acne Vulgaris, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Acne Vulgaris

Browse trials for

Keywords

  • Acne Vulgaris
  • Sarecycline
  • Doxycycline
  • Microbiome
04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

    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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Sarecycline Group

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

    Drug: Sarecycline

  • Experimental
    Doxycycline Group

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

    Drug: Doxycycline

Interventions

  • 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)

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Change in inflammatory and non-inflammatory lesions

    Assesing change in inflammatory and non-inflammatory lesions.

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

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

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

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

  3. Change in investigator global assessment of acne

    Change in investigator global assessment of acne

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

  4. 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.

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

  5. Change in skin microbiome relative abundance

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

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

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

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Apr 2027, 12 months later.

Of 45 phase 4 interventional studies under Acne Vulgaris, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 16. This study's planned 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2026
First posted
Apr 22, 2026
StartEst.
Apr 20, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Jun 2027
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07544251
Collaborators
Almirall, S.A.
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Nasima Afzal Chief Operating Officer
Contact
nasima@integrativeskinresearch.com
916-775-5080
Raja Sivamani, MD
principal investigator · Integrative Skin Science and Research

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Sarecycline · Doxycycline

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