Profiling the Skin Microbiome in Response to Altreno in Acne Patients

Study Overview
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Brief Summary
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The study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.

Detailed Description
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With the advent of 16S rRNA sequencing, scientific community is beginning to understand the critical importance of the microbiome in human health. In dermatology, researchers have begun to lead the effort to not only better understand how the microbiome contributes to the pathogenesis of skin disease, but also harness its power to develop novel therapies. Acne is a common inflammatory skin disorder. P. acnes on the skin has been traditionally thought of as the culprit bacteria in the pathogenesis of acne. Recent studies demonstrate that the skin microbial composition dynamically changes in response to systemic acne therapy. Using 16 rRNA gene sequencing, a prior study has confirmed that systemic antibiotic treatment decreased the abundance of P. acnes, which returned to baseline after discontinuation of the therapy. In contrast, the systemic therapy increased the abundance of Pseudomonas species, which returned to baseline after therapy cessation. Based on the opposing response to the therapy, it can be speculated that these two species compete for the same microenvironment within the skin microbiome. Interestingly, the same systemic therapy decreased the abundance of lactobacillus genus, the good bacteria that is protective against skin infection, and that decrease was sustained even after cessation of the therapy. Similarly, another study has demonstrated that systemic isotretinoin therapy disturbed the skin microbiome in acne patients with increased bacterial diversity on the cheeks. It is unclear the potential therapeutic role of the increased bacterial diversity in the management of acne patients. The study aims to characterize the shift in the diversity and abundance of the skin microbial community in response to Altreno in acne patients. Understanding the role of the skin microbiome in response to therapy can help clinicians to develop tailored, targeted treatment options, including reconstitution of good bacteria. Furthermore, it can lead to development of novel topical pre and probiotics.

Official Title
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Profiling the Skin Microbiome in Response to Altreno in Acne Patients

Conditions
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Acne, Healthy

Intervention / Treatment
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* Drug: Altreno
* Drug: Benzoyl peroxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed diagnosis of acne that warrants initiating topical medications. Denies use of any prescribed systemic acne treatments in the past 30 days. Denies use of any prescribed topical medications in the past 30 days. Denies use of any OTC topical acne medications in the past 14 days. Denies use of any emollients in the past 24 hours (if feasible). Denies bathing or facial washing in the past 12 hours (if feasible). Willingness to adhere to the recommended topical regimen during the duration of the study. Exclusion Criteria: Women who are pregnant, breastfeeding, or planning to get pregnant during the study. Use of any investigational drug(s) in the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Altreno Group<br> | Drug: Altreno<br>* Acne patients will be assigned to Altreno once daily.<br>|
| Experimental: BPO Group<br> | Drug: Benzoyl peroxide<br>* Acne patients will be assigned to BPO leave-on gel once daily.<br>|
| No Intervention: Control Group<br>During the entire study period, the subjects in the control group will not be allowed to use any antibacterial wash, other than approved OTC cleansers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the diversity of the skin microbiome before and after the treatment with Altreno. | The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index of the bacterial DNA in the skin microbiome. | Completion of study 120 days | 
| Change in the diversity of the skin microbiome before and after the treatment with Altreno. | The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome. | Completion of study 120 days | 
| Change in the diversity of the skin microbiome before and after the treatment with BPO therapy. | The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index of the bacterial DNA in the skin microbiome. | Completion of study 120 days | 
| Change in the diversity of the skin microbiome before and after the treatment with BPO therapy. | The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome. | Completion of study 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Leeds score | Score range is grade 1 to grade 12. Higher scores indicate a worse outcome | 120 days | 
| Change in the lesion count of inflammatory and non-inflammatory |  | 120 days |