Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Primary Purpose
Acne, Healthy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Altreno
Benzoyl peroxide
Sponsored by
About this trial
This is an interventional other trial for Acne
Eligibility Criteria
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.
Sites / Locations
- Beth Israel Deacones Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Altreno Group
BPO Group
Control Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Change in Leeds score
Score range is grade 1 to grade 12. Higher scores indicate a worse outcome
Change in the lesion count of inflammatory and non-inflammatory
Full Information
NCT ID
NCT04548349
First Posted
July 20, 2020
Last Updated
July 11, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Ortho Dermatologics
1. Study Identification
Unique Protocol Identification Number
NCT04548349
Brief Title
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Official Title
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Ortho Dermatologics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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) 2.5% 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Altreno Group
Arm Type
Experimental
Arm Title
BPO Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Altreno
Intervention Description
Acne patients will be assigned to Altreno once daily.
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide
Intervention Description
Acne patients will be assigned to BPO leave-on gel once daily.
Primary Outcome Measure Information:
Title
Change in the diversity of the skin microbiome before and after the treatment with Altreno.
Description
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index of the bacterial DNA in the skin microbiome.
Time Frame
Completion of study 120 days
Title
Change in the diversity of the skin microbiome before and after the treatment with Altreno.
Description
The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome.
Time Frame
Completion of study 120 days
Title
Change in the diversity of the skin microbiome before and after the treatment with BPO therapy.
Description
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index of the bacterial DNA in the skin microbiome.
Time Frame
Completion of study 120 days
Title
Change in the diversity of the skin microbiome before and after the treatment with BPO therapy.
Description
The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome.
Time Frame
Completion of study 120 days
Secondary Outcome Measure Information:
Title
Change in Leeds score
Description
Score range is grade 1 to grade 12. Higher scores indicate a worse outcome
Time Frame
120 days
Title
Change in the lesion count of inflammatory and non-inflammatory
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Beth Israel Deacones Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30758497
Citation
Chien AL, Tsai J, Leung S, Mongodin EF, Nelson AM, Kang S, Garza LA. Association of Systemic Antibiotic Treatment of Acne With Skin Microbiota Characteristics. JAMA Dermatol. 2019 Apr 1;155(4):425-434. doi: 10.1001/jamadermatol.2018.5221.
Results Reference
background
PubMed Identifier
28636791
Citation
Kelhala HL, Aho VTE, Fyhrquist N, Pereira PAB, Kubin ME, Paulin L, Palatsi R, Auvinen P, Tasanen K, Lauerma A. Isotretinoin and lymecycline treatments modify the skin microbiota in acne. Exp Dermatol. 2018 Jan;27(1):30-36. doi: 10.1111/exd.13397. Epub 2017 Sep 14.
Results Reference
background
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Profiling the Skin Microbiome in Response to Altreno in Acne Patients
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