Lipidome and Microbiome Profile of Acne

Sponsor
University of California, Davis (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02713607
Collaborator
(none)
30
1
2
130
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Study Details

Study Description

Brief 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 and how this is altered.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

We will look at acne subjects, and controls.

We will look at four things

  1. skin lipidome

  2. skin microbiome

  3. gut microbiome

  4. blood lipidome

Investigators will assess this in acne participants before and after doxycycline and compare them to controls.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Lipidome and Microbiome Profile of Acne
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: doxycycline

Given doxycycline and assessment of gut, blood and skin

Drug: Doxycycline
Given doxycycline to acne subjects

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Change in the diversity of the gut microbiome in those with and without acne. [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.

  2. Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne. [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.

Secondary Outcome Measures

  1. Change in global acne grade score [2 years]

  2. Change in the investigator global assessment of acne [2 years]

  3. Change in the lesion count of inflammatory and non-inflammatory lesions [2 years]

  4. Change in the diversity of the skin microbiome in those with and without acne [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.

  5. Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne [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.

  6. Change in the diversity of the skin lipidome in those with and without acne [2 years]

    The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

  7. Change in the skin lipidome before and after treatment with doxycycline in those with acne [2 years]

    The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

  8. Change in the diversity of the blood lipidome in those with and without acne [2 year]

    The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

  9. Change in the blood lipidome before and after treatment with doxycycline in those with [2 years]

    The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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).

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC Davis Dept of Dermatology Sacramento California United States 95816

Sponsors and Collaborators

  • University of California, Davis

Investigators

  • Principal Investigator: Raja K Sivamani, MD MS CAT, UCDavis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT02713607
Other Study ID Numbers:
  • 867744
First Posted:
Mar 21, 2016
Last Update Posted:
Jul 13, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2021