Profiling the Skin Microbiome in Response to Altreno in Acne Patients

NCT ID: NCT04548349

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2022-08-22

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.

Conditions

Acne; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Altreno Group

Group Type: EXPERIMENTAL

Altreno

Intervention Type: DRUG

Acne patients will be assigned to Altreno once daily.

BPO Group

Group Type: EXPERIMENTAL

Benzoyl peroxide

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Altreno

Acne patients will be assigned to Altreno once daily.

Intervention Type: DRUG

Benzoyl peroxide

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ortho Dermatologics

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jean S. McGee, MD, PhD

Assistant Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deacones Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30758497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28636791 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020P000595

Identifier Type: -

Identifier Source: org_study_id