Profiling the Skin Microbiome in Response to Altreno in Acne Patients

Healthy Clinical Trial

Official title:

Profiling the Skin Microbiome in Response to Altreno in Acne Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548349
• Other study ID #: 2020P000595
• Status: Completed
• Phase: Phase 4
• Start date: April 23, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: February 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris
• Healthy

Intervention

Drug:
• Altreno
Acne patients will be assigned to Altreno once daily.
• Benzoyl peroxide
Acne patients will be assigned to BPO leave-on gel once daily.

Locations

Country	Name	City	State
United States	Beth Israel Deacones Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Ortho Dermatologics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 90 days after treatment, and followed by 30 days of no treatment