Acne, Healthy
Conditions
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.
Interventions
DRUGAltreno
Acne patients will be assigned to Altreno once daily.
DRUGBenzoyl peroxide
Acne patients will be assigned to BPO leave-on gel once daily.
Sponsors
Ortho Dermatologics
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CLR-transformed Abundance of Any Significant Taxa | Baseline, 90 days after treatment, and followed by 30 days of no treatment | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.\*\*\*
Participants by arm
| Arm | Count |
|---|---|
| Altreno Group Altreno: Acne patients will be assigned to Altreno once daily. | 12 |
| 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. | 12 |
| BPO Group BPO: Acne patients will be assigned to BPO once daily. | 1 |
| Total | 25 |
Baseline characteristics
| Characteristic | Altreno Group | Control Group | BPO Group | Total |
|---|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 6.4 | 31.8 years STANDARD_DEVIATION 4.9 | 26 years STANDARD_DEVIATION 0 | 30.2 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 11 Participants | 1 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 12 Participants | 1 Participants | 22 Participants |
| Relative Abundance Altreno Group | 3.29 Relative Abundance | — | — | 3.29 Relative Abundance |
| Relative Abundance Control Group | — | -2.49 Relative Abundance | — | -2.49 Relative Abundance |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 1 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 0 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 1 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 1 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 1 |
Outcome results
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.
Time frame: Baseline, 90 days after treatment, and followed by 30 days of no treatment
Population: The participants analyzed differ because of lost to follow-up and/or not sufficient DNA yield for downstream microbiome sequencing.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Altreno Group | CLR-transformed Abundance of Any Significant Taxa | Baseline | 3.29 Relative Abundance |
| Altreno Group | CLR-transformed Abundance of Any Significant Taxa | +90 days from baseline | -1.59 Relative Abundance |
| Altreno Group | CLR-transformed Abundance of Any Significant Taxa | +120 days from baseline | -1.98 Relative Abundance |
| Control Group | CLR-transformed Abundance of Any Significant Taxa | Baseline | -2.49 Relative Abundance |
| Control Group | CLR-transformed Abundance of Any Significant Taxa | +90 days from baseline | -2.75 Relative Abundance |