Lipidome and Microbiome Profile of Acne

Acne Vulgaris Clinical Trial

Official title:

Lipidome and Microbiome Profile of Acne

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02713607
• Other study ID #: 867744
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: January 2027

Study information

• Verified date: December 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and how this is altered.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Doxycycline
Given doxycycline to acne subjects

Locations

Country	Name	City	State
United States	UC Davis Dept of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years
Secondary	Change in global acne grade score		2 years
Secondary	Change in the investigator global assessment of acne		2 years
Secondary	Change in the lesion count of inflammatory and non-inflammatory lesions		2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 year
Secondary	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.	2 years