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| Name | Class |
|---|---|
| Ortho Dermatologics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Altreno Group | Experimental |
| |
| BPO Group | Experimental |
| |
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altreno | Drug | Acne patients will be assigned to Altreno once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CLR-transformed Abundance of Any Significant Taxa | The primary outcome measures the relative abundance of Kingella after treatment with Altreno in acne patients vs without treatment in healthy subjects. The relative abundance was represented as centered log ratio (CLR) transformation. These values are all relative terms centered around 0, more negative means less abundant in comparison. More positive means more abundant in comparison. | Baseline, 90 days after treatment, and followed by 30 days of no treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deacones Medical Center | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30758497 | Background | 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. | |
| 28636791 | Background | 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. |
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The BPO arm was not included in this reporting. We only recruited 1 subject in this arm and did not reach the sufficient number needed to make meaningful comparisons. It was decided that we would proceed with comparing no acne vs. acne treated with Altreno. We did not pursue any downstream processing of the samples collected from that 1 patient, so no results are available for this arm. ***The BPO Arm, 1 subject enrolled, but no analysis formed.***
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| ID | Title | Description |
|---|---|---|
| FG000 | Altreno Group | Altreno (0.05% lotion): Acne patients will be assigned to Altreno once daily. |
| FG001 | Control Group | 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. |
| FG002 | BPO Group | BPO 2.5% leave-on gel: Acne patients will be assigned to BPO once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As described in the Pre-Assignment Details section, BPO arm was excluded from the study. We did not pursue processing the samples from 1 recruited subject in this arm. Therefore, we do not have any results to report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Altreno Group | Altreno: Acne patients will be assigned to Altreno once daily. |
| BG001 | Control Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CLR-transformed Abundance of Any Significant Taxa | The primary outcome measures the relative abundance of Kingella after treatment with Altreno in acne patients vs without treatment in healthy subjects. The relative abundance was represented as centered log ratio (CLR) transformation. These values are all relative terms centered around 0, more negative means less abundant in comparison. More positive means more abundant in comparison. | The participants analyzed differ because of lost to follow-up and/or not sufficient DNA yield for downstream microbiome sequencing. | Posted | Median | Inter-Quartile Range | Relative Abundance | Baseline, 90 days after treatment, and followed by 30 days of no treatment |
|
The adverse events were asked at each study visit. For both groups, adverse events were collected over ~120 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Altreno Group | Altreno 0.05% lotion: Acne patients will be assigned to Altreno once daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean S. McGee, MD, PhD | Beth Israel Deaconess Medical Center | (617) 667-5834 | jmcgee2@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2020 | Jan 5, 2024 | Prot_SAP_001.pdf |
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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 |
|---|---|
| D014212 | Tretinoin |
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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| Benzoyl peroxide |
| Drug |
Acne patients will be assigned to BPO leave-on gel once daily. |
|
| BG002 | BPO Group | BPO: Acne patients will be assigned to BPO once daily. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Relative Abundance | We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population. | We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population. | Median | Inter-Quartile Range | Relative Abundance |
|
| OG001 |
| Control Group |
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. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control Group | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | BPO Group | BPO 2.5% leave-on gel: Acne patients will be assigned to once or twice daily as tolerated. | 0 | 1 | 0 | 1 | 0 | 1 |
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| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|