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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Tetracycline for treating acne?

Research shows that tetracyclines, including tetracycline, are commonly used to treat acne due to their anti-inflammatory properties. In a study, high doses of tetracycline cleared or greatly improved severe acne in most patients, although side effects were noted in some cases. ^{1 2 3 4 5}

Is tetracycline safe for treating acne?

Tetracycline antibiotics, including minocycline and doxycycline, have been used for acne but can cause side effects like stomach issues, sensitivity to sunlight, and, rarely, more serious reactions. Newer tetracyclines like sarecycline are designed to be safer, with fewer side effects. ^{1 6 7 8 9}

How does the drug tetracycline differ from other acne treatments?

Tetracycline is unique because it not only fights bacteria but also reduces inflammation, making it effective for treating acne and other skin conditions. Unlike some newer antibiotics, tetracycline has been used for a long time and is known for its broad-spectrum antimicrobial properties. ^{3 5 10 11 12}

What is the purpose of this trial?

This trial tests an antibiotic that reduces inflammation in patients who still have symptoms after standard Lyme disease treatment. The goal is to see if it can improve symptoms like fatigue and pain. The antibiotic has been shown to reduce both bacterial load and inflammation.

Research Team

John N. Aucott, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Adverse Reactions Induced by Minocycline: A Review of Literature. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

High-dose tetracycline therapy in severe acne. [2016]

3. Sweden pubmed.ncbi.nlm.nih.gov

[Tetracyclines as anti-inflammatory treatment in skin diseases]. [2006]

4. Germany pubmed.ncbi.nlm.nih.gov

Oral tetracyclines may not be effective in treating acne: dominance of the placebo effect. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of tetracyclines in the treatment of acne vulgaris: a review. [2018]

6. United States 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The use and safety of doxycycline hyclate and other second-generation tetracyclines. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Oral Tetracyclines and Acne: A Systematic Review for Dermatologists. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Topical tetracycline in the treatment of acne vulgaris. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Second-generation tetracyclines, a dermatologic overview: clinical uses and pharmacology. [2013]

12. England pubmed.ncbi.nlm.nih.gov

High consumption of tetracyclines for acne treatment among young Danish adults. [2017]