30 Participants NeededMy employer runs this trial

Sarecycline vs Doxycycline for Acne

NA
Overseen ByNasima Afzal Chief Operating Officer
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Integrative Skin Science and Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two acne treatments, Sarecycline and Doxycycline, affect gut and skin bacteria. Researchers aim to determine if either treatment alters the types of bacteria in these areas. Participants will be divided into two groups, with some receiving Sarecycline and others receiving Doxycycline. Individuals with acne, having at least 10 inflamed pimples but no more than 2 large nodules on their face, may qualify for this study. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments benefit a broader range of patients.

Will I have to stop taking my current medications?

Yes, you may need to stop certain medications before joining the trial. Specifically, you should not have used topical acne medications, benzoyl peroxide, or anti-inflammatories on your face within 2 weeks, systemic antibiotics or acne treatments within 4 weeks, or systemic retinoids within 12 weeks before starting the study.

What is the safety track record for these treatments?

Previous studies have shown that sarecycline is generally well-tolerated, with few side effects. Approximately 4.7% of patients experienced mild adverse reactions. The FDA has approved sarecycline for treating certain types of acne, indicating a good safety record.

Research on doxycycline shows that it is effective but can cause some stomach-related side effects. Serious side effects are rare, making it a common choice. Both sarecycline and doxycycline are widely used antibiotics for acne and are considered safe for most people.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about sarecycline and doxycycline for acne because these treatments offer unique benefits compared to standard options like minocycline or tetracycline. Sarecycline is a next-generation tetracycline-derived antibiotic that is designed to specifically target acne-causing bacteria while minimizing side effects, such as gastrointestinal discomfort, which are common with other antibiotics. Doxycycline is a well-known antibiotic that not only targets bacteria but also reduces inflammation, making it a dual-action treatment option. Both treatments have the potential to enhance patient outcomes by providing more effective and tolerable options for managing acne.

What evidence suggests that this trial's treatments could be effective for acne?

This trial will compare the effectiveness of Sarecycline and Doxycycline for treating acne. Research has shown that both medications effectively treat acne. Participants in the Sarecycline Group will receive sarecycline, a newer medication that significantly reduces red, swollen acne spots and improves skin perception. Designed specifically for acne, sarecycline is taken once a day.

Participants in the Doxycycline Group will receive doxycycline, which kills bacteria and reduces skin swelling. Studies have shown it can greatly reduce acne spots, such as small red bumps and pus-filled spots, over time. Doxycycline is a well-known treatment for moderate to severe acne and has been used successfully for many years. Both medications are effective, but they work in slightly different ways.12367

Who Is on the Research Team?

RS

Raja Sivamani, MD

Principal Investigator

Integrative Skin Science and Research

Are You a Good Fit for This Trial?

This trial is for people with acne who have at least 10 inflamed pimples or bumps and up to 100 non-inflamed spots, with no more than 2 large nodules on the face.

Inclusion Criteria

I have at least 10 inflamed acne spots and up to 100 non-inflamed acne spots.
I have two or fewer nodules on my face.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either Sarecycline or Doxycycline to assess changes in gut and skin microbiome

4 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Doxycycline
  • Sarecycline

Trial Overview

The study compares two antibiotics, Sarecycline and Doxycycline, to see how each affects the bacteria on the skin and in the gut of people with acne. Participants are randomly assigned to one of these treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sarecycline GroupExperimental Treatment1 Intervention
Group II: Doxycycline GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Integrative Skin Science and Research

Lead Sponsor

Trials
33
Recruited
2,000+

Almirall, S.A.

Industry Sponsor

Trials
63
Recruited
19,200+

Carlos Gallardo Piqué

Almirall, S.A.

Chief Executive Officer since 2023

MS in Industrial Engineering from Universitat Politècnica de Catalunya, MBA from Stanford Graduate School of Business

Mercedes Diz

Almirall, S.A.

Chief Medical Officer since 2023

PhD in Biochemistry

Citations

Efficacy and safety of oral doxycycline for acne vulgaris ... - PMC

A notable finding was the superior improvement in Global Acne Grading System (GAGS) scores with control interventions compared to doxycycline (MD 1.76; 95% CI [ ...

Oral Doxycycline in the Management of Acne Vulgaris - PMC

This article reviews data with a new double-scored small 150mg tablet of doxycycline hyclate that has proven functional scoring, exhibits bioavailability ...

Comparisons of Efficacy and Safety of Different Doses ...

These results indicated that 40 mg/d of doxycycline may possess similar efficacy in the reduction of inflammatory lesions, as well as similar or ...

Effects of Subantimicrobial-Dose Doxycycline in the ...

Twice-daily SD doxycycline treatment significantly reduced the number of inflammatory and noninflammatory lesions in patients with moderate facial acne.

Doxycycline for Acne: How Long Do Side Effects Last?

Doxycycline treats acne by killing off bacteria on the skin, so the bacteria can't cause inflammation. Doxycycline also improves acne by lowering ...

Doxycycline and Minocycline for the Management of Acne

Data and clinical experience suggest that enteric-coated doxycycline, with its low rate of GI symptoms, may represent a more tolerable treatment option for many ...

Doxycycline Use and Adverse Events

Pulsed azithromycin treatment is as e ective and safe as 2-week-longer daily doxycycline treatment of acne vulgaris: a randomized, double-blind, noninferiority ...