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Lipidome and Microbiome Profile of Acne

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ClinicalTrials.gov Identifier: NCT02713607
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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
Acne Vulgaris Drug: Doxycycline 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.


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Study Type : Interventional  (Clinical Trial)
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 : March 2016
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in global acne grade score [ Time Frame: 2 years ]
  2. Change in the investigator global assessment of acne [ Time Frame: 2 years ]
  3. Change in the lesion count of inflammatory and non-inflammatory lesions [ Time Frame: 2 years ]
  4. Change in the diversity of the skin 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.

  5. Change in the diversity of the skin microbiome before and after treatment with 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.

  6. Change in the diversity of the skin lipidome in those with and without acne [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713607


Locations
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United States, California
UC Davis Dept of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, MD MS CAT UCDavis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02713607     History of Changes
Other Study ID Numbers: 867744
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents