Doxycycline for Acne

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, Davis

Must be taking: Doxycycline

Must not be taking: Systemic antibiotics, Isotretinoin, Proton pump inhibitors, Oral probiotics

Disqualifiers: Pregnancy, Autoimmune disorders, Diabetes, Immunodeficiencies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the antibiotic doxycycline affects individuals with acne. Researchers seek to observe its impact on the body's natural oils (lipidome) and the bacteria in the skin and gut (microbiome). Participants are divided into two groups: one taking doxycycline and the other not, to compare changes. Individuals prescribed doxycycline for acne and diagnosed by a dermatologist may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken certain antibiotics, isotretinoin, or oral probiotics recently. Also, you can't be using proton pump inhibitors or have changed your oral contraceptive brand within four weeks of starting the study.

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

Previous studies have shown that doxycycline is generally safe for treating acne. It is often chosen because it typically has fewer serious side effects than other antibiotics. Most people taking doxycycline may experience mild issues such as nausea, an upset stomach, or a skin rash. These side effects are usually not serious and often resolve on their own.

The FDA has already approved doxycycline for treating various infections, including acne, indicating that its safety is well understood. However, every medication can affect individuals differently. Prospective trial participants should discuss possible side effects with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Doxycycline is unique because it not only addresses acne by targeting bacteria but also explores its effects on gut, blood, and skin environments. Unlike typical acne treatments like topical retinoids or benzoyl peroxide, doxycycline is an oral antibiotic that may offer a broader impact on the body's microenvironments. Researchers are excited about its potential dual benefits: reducing acne symptoms while also possibly improving overall skin health through its systemic effects.

What evidence suggests that doxycycline might be an effective treatment for acne?

Research has shown that doxycycline effectively treats acne. In this trial, participants will receive doxycycline, which studies have demonstrated can greatly reduce acne spots. One study found that people taking doxycycline had much better results than those taking a placebo (a pill with no active ingredients). Doxycycline reduces swelling and slows the growth of bacteria that cause acne. Both regular and lower doses of doxycycline have been shown to help clear up acne, making it a flexible treatment option. ^{1 2 6 7 8}

Who Is on the Research Team?

Raja K Sivamani, MD MS CAT

Principal Investigator

UCDavis

Are You a Good Fit for This Trial?

This trial is for individuals aged 15 and older who have acne diagnosed by a dermatologist and are prescribed or eligible for Doxycycline. They must understand the study procedures and consent forms. Excluded are those with certain chronic diseases, recent antibiotic use, allergies to tetracyclines, high BMI, or on specific medications.

Inclusion Criteria

Subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms.

I am 15 years old or older.

I am currently taking or am eligible to take Doxycycline for my acne.

Exclusion Criteria

I have not taken isotretinoin in the last six weeks.

I have seborrheic dermatitis, rosacea, or polycystic ovary syndrome.

I have recently started or changed my birth control pill.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive doxycycline and undergo assessment of gut, blood, and skin microbiomes and lipidomes

2 years

Follow-up

Participants are monitored for changes in microbiome and lipidome profiles after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Doxycycline

Trial Overview

The study examines how Doxycycline affects the lipidome (fats in blood and skin) and microbiome (bacteria in gut and skin) of people with acne compared to controls without treatment. It aims to understand changes due to antibiotics in these biological profiles.

How Is the Trial Designed?

Group I: doxycycline Experimental Treatment 1 Intervention

Given doxycycline and assessment of gut, blood and skin

Group II: Control Active Control 1 Intervention

Control subjects to assess if there is baseline difference in these micro-evironments.

Doxycycline is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Doxycycline for:

• Acne
• Bacterial infections
• Chlamydia
• Gonorrhea
• Lyme disease
• Malaria
• Pneumonia
• Rosacea
• Urinary tract infections

Approved in European Union as Doxycycline for:

• Acne
• Bacterial infections
• Chlamydia
• Gonorrhea
• Lyme disease
• Malaria
• Pneumonia
• Rosacea
• Urinary tract infections

Approved in Canada as Doxycycline for:

• Acne
• Bacterial infections
• Chlamydia
• Gonorrhea
• Lyme disease
• Malaria
• Pneumonia
• Rosacea
• Urinary tract infections

Approved in Japan as Doxycycline for:

• Acne
• Bacterial infections
• Chlamydia
• Gonorrhea
• Lyme disease
• Malaria
• Pneumonia
• Rosacea
• Urinary tract infections

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

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 16-week study involving 12 participants with inflammatory acne, a maintenance dose of 20 mg of doxycycline hyclate taken twice daily was effective in maintaining improvement after an initial treatment phase.

After the first eight weeks of treatment with 100 mg daily, 11 out of 12 subjects showed a 50% reduction in acne lesions, and those who continued with the lower dose of doxycycline maintained their improvement, while the placebo group did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of acne vulgaris with low dosage doxycycline. Parish, LC., Parish, JL., Routh, HB., et al.[2022]

In a study involving 51 adults with moderate acne, treatment with subantimicrobial-dose doxycycline significantly reduced the number of acne lesions compared to placebo, demonstrating its efficacy in improving clinical outcomes.

The treatment was well tolerated and did not alter skin flora or increase antibiotic resistance, indicating it is a safe option for managing moderate acne without the risk of promoting resistant bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of subantimicrobial-dose doxycycline in the treatment of moderate acne. Skidmore, R., Kovach, R., Walker, C., et al.[2022]

Doxycycline calcium demonstrated a dose-response effect in treating moderate to severe inflammatory acne, with the highest dose (2.4 mg/kg/day) showing significant improvement compared to placebo over a 12-week period.

The study confirmed that higher doses not only improved acne symptoms but also had a measurable incidence of gastrointestinal side effects, indicating a need for careful dose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, phase 2, dose-ranging study in the treatment of moderate to severe inflammatory facial acne vulgaris with doxycycline calcium. Leyden, JJ., Bruce, S., Lee, CS., et al.[2013]

In a study of 49 patients with moderate acne, minocycline showed a faster time to achieve noninflammatory acne status compared to tetracycline, with twice as many patients reaching this status after six weeks.

Both treatments had similar side effects, and no significant abnormalities were found in blood tests, indicating that minocycline is a safe and effective option for treating acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of minocycline compared with tetracycline in treatment of acne vulgaris. Hubbell, CG., Hobbs, ER., Rist, T., et al.[2013]

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]

A review by the French National Pharmacovigilance Committee found that minocycline was associated with more frequent and severe adverse effects compared to doxycycline during tetracycline therapy.

Minocycline was linked to a higher incidence of life-threatening hypersensitivity reactions and autoimmune effects, indicating a less favorable risk-benefit balance, especially for treating acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fewer adverse effects with doxycycline than with minocycline. [2013]

Citations

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36 In patients treated with minocycline, 15.9 to 17.3 percent achieved success, compared to only 7.9 to 9.5 percent treated with placebo.36 No ...

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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 ...