NCT03820076

Safety Study of AZT-04 for Cosmetic Use

Completed NA Last updated 9 July 2020

What this trial tests

NA trial testing AZT-04 in Study of Three Doses of AZT-04 for Skin Appearance in 21 participants. Completed in 31 July 2019.

Timeline

17 January 2019

Primary endpoint
21 January 2019

31 July 2019

Quick facts

Lead sponsor	Azitra Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	21
Start date	17 January 2019
Primary completion	21 January 2019
Estimated completion	31 July 2019
Sites	1 location across United States

Drugs / interventions tested

• AZT-04

Conditions studied

• Study of Three Doses of AZT-04 for Skin Appearance — all drugs for Study of Three Doses of AZT-04 for Skin Appearance →

Sponsor

Azitra Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Study of Three Doses of AZT-04 for Skin Appearance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Double Blind, Three Cohort, Placebo-controlled Trial to Assess Safety, Tolerance and Induced Bacterial Colony Counts of Three Ascending Doses of AZT-04 in Healthy Adult Volunteers

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skin microbiome transplantation and manipulation: Current state of the art.
   Callewaert C, Knödlseder N, Karoglan A, Güell M, et al · · 2021 · cited 57× · PMID 33510866 · DOI 10.1016/j.csbj.2021.01.001
2. A Review of Clinical Trials Involving Genetically Modified Bacteria, Bacteriophages and Their Associated Risk Assessments.
   Gulig P, Swindle S, Fields M, Eisenman D. · · 2024 · cited 6× · PMID 39735407 · DOI 10.1089/apb.2024.0002