Profiling the Skin Microbiome in Response to Altreno in Acne Patients

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Acne
• Intervention / Treatment: Drug: Altreno; Drug: Benzoyl peroxide

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 617-667-5201; Email: jmcgee2@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deacones Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Altreno Group	Drug: Altreno; Acne patients will be assigned to Altreno once daily.
Experimental: BPO Group	Drug: Benzoyl peroxide; Acne patients will be assigned to BPO leave-on gel once daily.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Ortho Dermatologics

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Benzoyl Peroxide
• Other Study ID Numbers: 2020P000595

Drug and device information, study documents

• 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