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| Name | Class |
|---|---|
| Almirall, S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarecycline Group | Experimental | Half of the participants will be randomized to receive sarecycline treatment. |
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| Doxycycline Group | Experimental | Half of the participants will be randomized to receive doxycycline treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarecycline | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the relative abundance of tetracycline-resistant bacteria in the gut microbiome | Assessing change in the relative abundance of tetracycline resistant bacteria in the gut microbiome following treatment. | From enrollment to the end of treatment at 4 weeks. |
| Change in the relative abundance of fungi/yeast in the gut microbiome | Assessing change in the relative abundance of fungi/yeast in the gut microbiome following treatment. | From enrollment to the end of treatment at 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory and non-inflammatory lesions | Assesing change in inflammatory and non-inflammatory lesions. | From enrollment to the end of treatment at 4 weeks. |
| Change in the diversity of the gut microbiome: Shannon Diversity |
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Inclusion Criteria:
1) Diagnosis of acne vulgaris with:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasima Afzal Chief Operating Officer | Contact | 916-775-5080 | nasima@integrativeskinresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Raja Sivamani, MD | Integrative Skin Science and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Research Institute | Recruiting | Sacramento | California | 95819 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000629276 | sarecycline |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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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.
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| Doxycycline | Drug | 100 mg twice daily with food and a full glass of water (about 8 ounces) |
|
Assessing the change in Alpha Diversity of the gut microbiome via Shannon Diversity
| From enrollment to the end of treatment at 4 weeks. |
| Change in investigator global assessment of acne | Change in investigator global assessment of acne | From enrollment to the end of treatment at 4 weeks. |
| Change in relative abundance of short chain fatty acid production genes | Assessing change in relative abundance of short chain fatty acid production genes upon gut microbiome analysis. | From enrollment to the end of treatment at 4 weeks. |
| Change in skin microbiome relative abundance | Assessing change in the relative abundance of the skin microbiome via Shannon Diversity. | From enrollment to the end of treatment at 8 weeks. |
| Change in the skin microbiome relative abundance of fungi/yeast | Assessing change in the relative abundance of fungi/yeast in the skin microbiome. | From enrollement to the end of treatment at 4 weeks. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |