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Completed

NCT Number: NCT04548349

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beth Israel Deacones Medical Center

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Altreno

Drug

Acne patients will be assigned to Altreno once daily.

Benzoyl peroxide

Drug

Acne patients will be assigned to BPO leave-on gel once daily.

Primary outcomes

  1. CLR-transformed Abundance of Any Significant Taxa

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Ortho Dermatologics

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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