Acne VulgarisPhase 1/2NCT02713607
Lipidome and Microbiome Profile of Acne
A Phase 1/2 study testing Doxycycline in people with Acne Vulgaris, run by University of California, Davis at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 15 and older
- Subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms.
- Have already been prescribed Doxycycline by their physician for acne or to be eligible to be prescribed Doxycycline for acne
- Have acne that is diagnosed by a board certified dermatologist.
Who cannot join
- Those who have received systemic antibiotics within four weeks of starting the study.
- Those who have received systemic isotretinoin within six weeks of starting the study.
- Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- Those who are pregnant, prisoners or cognitively impaired.
- Those subjects who are currently using proton pump inhibits (as studies have shown this may impact the gut microbiome) (4)
- Those who have a BMI greater than >30 kg/m2, as studies have shown a reduction in the variability of intestinal microbes within this population (5).
Show all 13Show fewer
- Those who have initiated or changed brand of oral contraceptive pill within 4 weeks of starting the study.
- Those who have autoimmune disorders as this group has been shown to have an altered microbiome (6)
- Those who have diabetes (6), immunodeficiencies (7), inflammatory bowel disease (6), hypercholesterolemia, as these groups have been shown to have altered gut microbiomes
- Those who have taken oral probiotic supplements (8) within 4 weeks of starting the study
- Given the nature of the instructions that need to be adhered to for accurate collection of samples and this data, non-English speaking individuals will be excluded from this pilot study.
- Allergies to the tetracycline group of antibiotics
- Those who do not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Dept of Dermatology
Sacramento, California, 95816
About this study
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.
Read the detailed description
We will look at acne subjects, and controls.
We will look at four things
- skin lipidome
- skin microbiome
- gut microbiome
- blood lipidome
Investigators will assess this in acne participants before and after doxycycline and compare them to controls.
- Conditions
- Acne Vulgaris
- Being tested
- Doxycycline
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Given doxycycline to acne subjects
| Study group | Role | What they receive |
|---|---|---|
| doxycycline | Experimental | Given doxycycline and assessment of gut, blood and skin Receives: Drug: Doxycycline |
| Control | No intervention | Control subjects to assess if there is baseline difference in these micro-evironments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the diversity of the gut microbiome in those with and without acne.
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
Measured: 2 years
Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
Measured: 2 years
Secondary outcomes (9)
Change in global acne grade score
Measured: 2 years
Change in the investigator global assessment of acne
Measured: 2 years
Change in the lesion count of inflammatory and non-inflammatory lesions
Measured: 2 years
Change in the diversity of the skin microbiome in those with and without acne
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
Measured: 2 years
Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
Measured: 2 years
Change in the diversity of the skin lipidome in those with and without acne
The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.
Measured: 2 years
Change in the skin lipidome before and after treatment with doxycycline in those with acne
The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.
Measured: 2 years
Change in the diversity of the blood lipidome in those with and without acne
The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.
Measured: 2 year
Change in the blood lipidome before and after treatment with doxycycline in those with
The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD MS CAT, Principal investigator, UCDavis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713607
- Sponsor's protocol ID
- 867744
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2016
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipidome and Microbiome Profile of Acne
- ClinicalTrials.gov ID
- NCT02713607
- Acronym / sponsor ID
- 867744
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will look at acne subjects, and controls.
We will look at four things
- skin lipidome
- skin microbiome
- gut microbiome
- blood lipidome
Investigators will assess this in acne participants before and after doxycycline and compare them to controls.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxycycline | Experimental | Drug: DoxycyclineGiven doxycycline and assessment of gut, blood and skin |
| Control | No intervention | –Control subjects to assess if there is baseline difference in these micro-evironments. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 15 and older
- Subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms.
- Have already been prescribed Doxycycline by their physician for acne or to be eligible to be prescribed Doxycycline for acne
- Have acne that is diagnosed by a board certified dermatologist.
Key exclusion criteria (13 listed)
- Those who have received systemic antibiotics within four weeks of starting the study.
- Those who have received systemic isotretinoin within six weeks of starting the study.
- Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- Those who are pregnant, prisoners or cognitively impaired.
- Those subjects who are currently using proton pump inhibits (as studies have shown this may impact the gut microbiome) (4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineGiven doxycycline to acne subjects | Drug | doxycycline |
Primary outcome
Change in the diversity of the gut microbiome in those with and without acne.
Time frame: 2 years
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.
Time frame: 2 years
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
9 secondary outcomes
Change in global acne grade score
Time frame: 2 years
Change in the investigator global assessment of acne
Time frame: 2 years
Change in the lesion count of inflammatory and non-inflammatory lesions
Time frame: 2 years
Change in the diversity of the skin microbiome in those with and without acne
Time frame: 2 years
Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne
Time frame: 2 years
Change in the diversity of the skin lipidome in those with and without acne
Time frame: 2 years
Change in the skin lipidome before and after treatment with doxycycline in those with acne
Time frame: 2 years
Change in the diversity of the blood lipidome in those with and without acne
Time frame: 2 year
Change in the blood lipidome before and after treatment with doxycycline in those with
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja K Sivamani, MD MS CAT principal investigator
UCDavis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Doxycycline in people with Acne Vulgaris, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the diversity of the gut microbiome in those with and without acne. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.