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Antibiotic
Doxycycline for Acne
Phase 1 & 2
Waitlist Available
Led By Raja K Sivamani, MD MS CAT
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 15 and older
Have already been prescribed Doxycycline by their physician for acne or to be eligible to be prescribed Doxycycline for acne
Must not have
Currently using proton pump inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Approved for 60 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial will analyze the lipidome and microbiome of subjects with acne in order to better understand the role of these substances in the development and treatment of acne.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Doxycycline may cause side effects such as stomach upset, diarrhea, sun sensitivity, discoloration of teeth if used long term in children under age 8, rash or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 15 years old or older.
Select...
I am currently taking or am eligible to take Doxycycline for my acne.
Select...
My acne has been diagnosed by a skin specialist.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for stomach acid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.
Change in the diversity of the gut microbiome in those with and without acne.
Secondary study objectives
Change in the blood lipidome before and after treatment with doxycycline in those with
Change in the diversity of the blood lipidome in those with and without acne
Change in the diversity of the skin lipidome in those with and without acne
+3 moreSide effects data
From 2022 Phase 4 trial • 449 Patients • NCT040505403%
Malaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care Arm
dPEP Intervention Arm
Awards & Highlights
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, DavisLead Sponsor
939 Previous Clinical Trials
4,739,703 Total Patients Enrolled
4 Trials studying Acne
376 Patients Enrolled for Acne
Raja K Sivamani, MD MS CATPrincipal InvestigatorUCDavis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have not taken any probiotic supplements in the last 4 weeks.You are very overweight.You are allergic to tetracycline antibiotics.I have not taken antibiotics in the last four weeks.I am currently taking medication for stomach acid.I have an autoimmune disorder, diabetes, immunodeficiency, inflammatory bowel disease, or high cholesterol.I am 15 years old or older.I am currently taking or am eligible to take Doxycycline for my acne.My acne has been diagnosed by a skin specialist.
Research Study Groups:
This trial has the following groups:- Group 1: doxycycline
- Group 2: Control
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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