NCT04548349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

April 23, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 6, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

July 20, 2020

Results QC Date

November 17, 2023

Last Update Submit

February 3, 2024

Conditions

AcneHealthy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Altreno Group

EXPERIMENTAL
Drug: Altreno

BPO Group

EXPERIMENTAL
Drug: Benzoyl peroxide

Control Group

NO INTERVENTION

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.

Interventions

AltrenoDRUG

Acne patients will be assigned to Altreno once daily.

Altreno Group
Benzoyl peroxideDRUG

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

BPO Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Women who are pregnant, breastfeeding, or planning to get pregnant during the study.
  • Use of any investigational drug(s) in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deacones Medical Center

Boston, Massachusetts, 02115, United States

Location

Related 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.

    PMID: 30758497BACKGROUND

  • 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.

    PMID: 28636791BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

TretinoinBenzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, Aromatic

Limitations and Caveats

* BPO arm only have 1 participant, so we decided to drop this arm. * Small sample size, high drop out rate, and high failure rate of DNA extraction were the limitations of this study among others.

Results Point of Contact

Title
Jean S. McGee, MD, PhD
Organization
Beth Israel Deaconess Medical Center
jmcgee2@bidmc.harvard.edu
(617) 667-5834

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology

Study Record Dates

First Submitted

July 20, 2020

First Posted

September 14, 2020

Study Start

April 23, 2021

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

February 6, 2024

Results First Posted

February 6, 2024

Record last verified: 2024-02

Locations

US(1)