Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Sarecycline, Doxycycline, Microbiome
Brief summary
This study is being done to help better understand how the gut and skin bacteria of the body change when people with acne are treated with Sarecycline or Doxycycline. The bacteria in the gut and on the skin will be studied to see how each treatment may affect them and whether they change the profile of the bacteria that is present.
Interventions
DRUGSarecycline
One tablet by mouth (weight based dosing at 1.5 mg/kg and rounded to the closest tablet dose at either 60 mg, 100mg, or 150 mg tablet) once a day with food and a full glass of water (about 8 ounces)
DRUGDoxycycline
100 mg twice daily with food and a full glass of water (about 8 ounces)
Sponsors
Integrative Skin Science and Research
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized into two groups, each group receiving a different oral antibiotics ( sarecycline or doxycycline). Changes in relative abundance of tetracycline resistant bacteria will be assessed and compared among the two groups over the course of four weeks.
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\) Diagnosis of acne vulgaris with: * At least 10 inflammatory lesions (papules, pustules, and nodules) up to 100 noninflammatory lesions (open and closed comedones) * No more than 2 nodules on the face
Exclusion criteria
1. Dermatological condition of face or facial hair that could interfere with clinical evaluations 2. Subjects who have used the following medications (topical refers only to the facial area) will not be eligible: 2a) Within 2 week prior to randomization: * Topical acne medications such as retinoids, antibiotics, hormonal modulators * Topical benzoyl peroxide * Topical anti-inflammatories and corticosteroids 2b) Within 4 weeks prior to randomization: * Systemic antibiotics * Systemic acne treatments * Oral probiotic supplement * Systemic corticosteroids 2c) Within 12 weeks prior to randomization: * Systemic retinoids 3\) Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study. 4\) Individuals who are pregnant or breastfeeding. 5\) Individuals on oral contraceptive pills or progesterone or estrogen containing therapies unless they have been on a stable dose for 2 months. 6\) Individuals on finasteride or dutasteride 7\) Current tobacco smoker or a tobacco smoking history that is greater than 5 pack-years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome | From enrollment to the end of treatment at 4 weeks. | Assessing change in the relative abundance of tetracycline resistant bacteria in the gut microbiome following treatment. |
| Change in the relative abundance of fungi/yeast in the gut microbiome | From enrollment to the end of treatment at 4 weeks. | Assessing change in the relative abundance of fungi/yeast in the gut microbiome following treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory and non-inflammatory lesions | From enrollment to the end of treatment at 4 weeks. | Assesing change in inflammatory and non-inflammatory lesions. |
| Change in the diversity of the gut microbiome: Shannon Diversity | From enrollment to the end of treatment at 4 weeks. | Assessing the change in Alpha Diversity of the gut microbiome via Shannon Diversity |
| Change in investigator global assessment of acne | From enrollment to the end of treatment at 4 weeks. | Change in investigator global assessment of acne |
| Change in relative abundance of short chain fatty acid production genes | From enrollment to the end of treatment at 4 weeks. | Assessing change in relative abundance of short chain fatty acid production genes upon gut microbiome analysis. |
| Change in skin microbiome relative abundance | From enrollment to the end of treatment at 8 weeks. | Assessing change in the relative abundance of the skin microbiome via Shannon Diversity. |
| Change in the skin microbiome relative abundance of fungi/yeast | From enrollement to the end of treatment at 4 weeks. | Assessing change in the relative abundance of fungi/yeast in the skin microbiome. |
Countries
United States
Contacts
CONTACTNasima Afzal Chief Operating Officer
PRINCIPAL_INVESTIGATORRaja Sivamani, MD
Integrative Skin Science and Research
Outcome results
None listed