Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548349
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-07-20
Brief Title:
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 25 leave-on gel monotherapy in acne patients
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None