Tetracycline for Acne

(T-4 Trial)

Overseen By Isabella Brothers

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Antibiotics, Immunosuppressives, Calcium

Disqualifiers: Chronic fatigue, Fibromyalgia, Autoimmune, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of tetracycline, an antibiotic, for individuals with persistent Lyme disease symptoms, such as fatigue. Participants will receive either tetracycline or a placebo (a fake pill) for three months, then switch to the other treatment for another three months. The goal is to determine if tetracycline relieves symptoms more effectively than the placebo. Ideal participants have had Lyme disease in the past five years, continue to experience symptoms affecting daily life, and have not used antibiotics in the last two months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antibiotics, immunosuppressive drugs, and those that interact with tetracycline. There is also a one-week washout period (time without taking certain medications) before starting the trial.

Is there any evidence suggesting that tetracycline is likely to be safe for humans?

Research shows that tetracycline is a well-researched antibiotic for treating acne. Studies confirm its low risk of causing antibiotic resistance, meaning it is unlikely to lose effectiveness over time. Other research indicates that tetracycline and similar antibiotics are generally safe, with most people experiencing few serious side effects. However, like any antibiotic, it can cause mild side effects such as an upset stomach or increased sensitivity to sunlight. These side effects are usually not severe, but awareness is important. Overall, based on its history and research findings, tetracycline is considered safe for treating acne. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tetracycline is unique because it offers a well-known antibiotic approach to tackling acne, focusing on reducing inflammation and bacterial growth. Unlike topical treatments like benzoyl peroxide or retinoids, tetracycline is taken orally, which can be more convenient for some patients and might offer more consistent results for moderate to severe acne. Researchers are excited about tetracycline's ability to address acne from within, potentially leading to clearer skin with fewer side effects compared to some harsher topical solutions.

What is the effectiveness track record for tetracycline in treating acne?

Research has shown that tetracycline treats acne by stopping the growth of bacteria that often cause skin inflammation. Studies have found that tetracycline effectively reduces acne symptoms and improves skin condition. As a commonly used oral antibiotic for managing acne with inflammation, it remains a trusted option for many. However, concerns exist about bacteria developing resistance to antibiotics with prolonged use. In this trial, participants will receive tetracycline for either the first or second three months, with a placebo given during the alternate period, to evaluate its effectiveness and any potential resistance development. ^{1 3 4 6 7}

Who Is on the Research Team?

John N. Aucott, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults aged 18-80 with a documented history of Lyme disease onset within the last 5 years and symptoms starting within a year. Participants must have persistent symptoms that affect daily life, have been treated with antibiotics for Lyme disease, and score at least 4.0 on the Fatigue Severity Scale.

Inclusion Criteria

I have been treated for PTLD as per IDSA guidelines.

I have been treated for PTLD with antibiotics as per IDSA guidelines.

I have a confirmed case of Lyme disease without any other diagnosis.

Exclusion Criteria

I have not had thoughts of harming myself in the last 6 months.

I have not had any major health issues in the last 4 months.

My BMI is over 40.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tetracycline or placebo for 3 months

12 weeks

Regular visits for monitoring

Crossover Treatment

Participants switch to the alternate treatment for another 3 months with blind maintained

12 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for the return of symptoms and overall tolerability

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Tetracycline

Trial Overview The trial is testing Tetracycline's effectiveness in treating Lyme Disease against a placebo over two periods of three months each. Patients are randomly assigned to start with either the drug or placebo, then switch after three months without knowing which one they're taking.

How Is the Trial Designed?

Group I: Tetracycline First Active Control 2 Interventions

Tetracycline for first 3 months, placebo for second 3 months.

Group II: Placebo First Placebo Group 2 Interventions

Placebo for first 3 months, tetracycline for second 3 months.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Steve and Alexandra Cohen Foundation

Collaborator

Published Research Related to This Trial

Doxycycline hyclate (DH) has a favorable safety profile, especially in its delayed-release form (Doryx), compared to the standard powder form (Vibramycin), making it a safer option for treating conditions like acne and rosacea.

Despite historical safety concerns associated with tetracyclines, including gastrointestinal issues and effects on tooth development, subantimicrobial dosing of DH has shown to be effective and safe for acne treatment, supporting its continued use in dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use and safety of doxycycline hyclate and other second-generation tetracyclines. Sloan, B., Scheinfeld, N.[2022]

In a phase 2 study involving 285 patients aged 12 to 45, sarecycline at doses of 1.5 mg/kg and 3.0 mg/kg significantly reduced inflammatory acne lesions compared to placebo, demonstrating its efficacy as a treatment for moderate to severe acne.

Sarecycline was found to be safe and well tolerated, with low rates of adverse events, including gastrointestinal issues, and no serious adverse events reported, suggesting it has a favorable safety profile compared to other antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Sarecycline, a Novel, Once-Daily, Narrow Spectrum Antibiotic for the Treatment of Moderate to Severe Facial Acne Vulgaris: Results of a Phase 2, Dose-Ranging Study. Leyden, JJ., Sniukiene, V., Berk, DR., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06225570

Weekly Isotretinoin vs Tetracycline for Moderate Acne A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9405006/

Antibiotic Resistance Risk with Oral Tetracycline Treatment ... This paper examines the growing concerns of antibiotic resistance due to oral tetracycline usage in the treatment of acne vulgaris.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17986300/

Efficacy of tetracyclines in the treatment of acne vulgaris Oral tetracyclines are routinely used for the management of inflammatory acne. However, there is a lack of evidence-based data on their relative effectiveness ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/der2.49

Treating acne with the tetracycline class of antibiotics: A ... The tetracycline class of antibiotics inhibits C. acnes growth in the pilosebaceous unit thus making the tetracyclines successful in treating acne.

5. medicine.yale.edu medicine.yale.edu/news-article/antibiotics-for-acne-groundbreaking-study-shows-why-one-works-best/

Antibiotics for Acne: Groundbreaking Study Shows Why One ... A new study brings precision to the understanding of which antibiotics work best for acne treatment and why. This is important for two key reasons.

6. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1413944/full

Safety profiles of doxycycline, minocycline, and tigecycline ... Using real-world data from the FAERS, this study evaluated the safety profiles of three tetracyclines in pediatric patients. Our findings ...

7. jcadonline.com jcadonline.com/sarecycline-narrow-spectrum-tetracycline-concept/

Sarecycline and the Narrow-spectrum Tetracycline Concept The available data on oral sarecycline use for treatment of acne in RCTs supports both efficacy and favorable safety, including a very low incidence of AEs ...