30 Participants Needed

Doxycycline for Acne

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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

Research shows that Doxycycline, especially in low doses, is effective in reducing acne lesions. In one study, 11 out of 12 participants had a 50% reduction in acne lesions after eight weeks of treatment with Doxycycline hyclate. Another study found that a combination of Doxycycline with other topical treatments significantly improved severe acne in most patients by week 12.12345

Is doxycycline safe for treating acne?

Doxycycline is generally considered safe for treating acne, but it can cause side effects like stomach issues, sensitivity to sunlight, and, rarely, severe allergic reactions. It is usually safer than minocycline, another acne treatment, but there have been rare cases of serious hypersensitivity reactions.16789

How is the drug doxycycline unique in treating acne?

Doxycycline is unique in treating acne because it is often preferred over other tetracyclines due to its safer and milder side-effect profile, and it can be effective even at low doses, which helps maintain improvement in acne symptoms.17101112

What is the purpose of this trial?

Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome.Investigators will look at the changes between acne subjects and control participants, but also the changes that occur after the use of antibiotics and how this is altered.

Research Team

RK

Raja K Sivamani, MD MS CAT

Principal Investigator

UCDavis

Eligibility Criteria

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.
See 1 more

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.
See 9 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: doxycyclineExperimental Treatment1 Intervention
Given doxycycline and assessment of gut, blood and skin
Group II: ControlActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

Findings from Research

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.
The treatment of acne vulgaris with low dosage doxycycline.Parish, LC., Parish, JL., Routh, HB., et al.[2022]
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.
Efficacy of minocycline compared with tetracycline in treatment of acne vulgaris.Hubbell, CG., Hobbs, ER., Rist, T., et al.[2013]
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.
Effects of subantimicrobial-dose doxycycline in the treatment of moderate acne.Skidmore, R., Kovach, R., Walker, C., et al.[2022]

References

The treatment of acne vulgaris with low dosage doxycycline. [2022]
Efficacy of minocycline compared with tetracycline in treatment of acne vulgaris. [2013]
Effects of subantimicrobial-dose doxycycline in the treatment of moderate acne. [2022]
Acne treatment: a comparative efficacy trial of clindamycin and tetracycline. [2013]
Anti-Inflammatory Dose Doxycycline Plus Adapalene 0.3% and Benzoyl Peroxide 2.5% Gel for Severe Acne [2019]
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]
Severe drug hypersensitivity reaction in a young woman treated with doxycycline. [2013]
The use and safety of doxycycline hyclate and other second-generation tetracyclines. [2022]
Fewer adverse effects with doxycycline than with minocycline. [2013]
10.United Statespubmed.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. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
Doxycycline-induced cutaneous inflammation with systemic symptoms in a patient with acne vulgaris. [2022]
12.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Adverse Reactions Induced by Minocycline: A Review of Literature. [2021]
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