Safety Study of AZT-04 for Cosmetic Use | NCT03820076

Studies
Safety Study of AZT-04 for Cosmetic Use

NCT03820076

Sponsor

Azitra Inc.

Status

Completed

Last Update Posted

Jul 9, 2020Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Study of Three Doses of AZT-04 for Skin Appearance

Interventions

AZT-04

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2019Actual

Primary Completion Date

Jan 21, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

Jan 25, 2019

First Submission Date that Met QC Criteria

Jan 28, 2019

First Posted Date

Jan 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2020

Last Update Posted Date

Jul 9, 2020Actual

Name	Class
RCTs	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a single-center, prospective, double-blind, three cohort pilot study to assess the tolerability and induced changes in skin microbiome population and diversity of three ascending doses of test article code AZT-04 in normal, healthy subjects.

The study will consist of up to 7 scheduled study visits. There will be three cohorts in this study, each cohort composed of 6 subjects (total number of subjects is at least 18). Each cohort will be treated with both a placebo ointment and an ointment containing different concentrations of the Staphylococcus epidermidis. Approximately 1 ml of placebo ointment and 1 ml of AZT-04 ointment (test product composed of a commensal strain of Staphylococcus epidermidis) will be applied topically to two separate skin sites on the back, each site approximately 8 x 5 cm. Skin microbiome sampling will be performed before application of any test article (i.e., baseline) and each subsequent day for four (4) consecutive days. Samples will be shipped to a laboratory chosen by the Sponsor for analyses

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dose 1	Experimental	AZT-04	Other: AZT-04
dose 2	Experimental	AZT-04	Other: AZT-04
dose 3	Experimental	AZT-04	Other: AZT-04

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZT-04	Other	Staphylococcus epidermidis	dose 1 dose 2 dose 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerance: mean erythema	to demonstrate the tolerability of three different doses of AZT-04 containing Staphylococcus epidermidis compared to placebo in healthy adult population--as s measured by mean erythema scores	9 days

Secondary Outcomes

Measure	Description	Time Frame
Bacterial Count	to assess the colonization of the test articles and placebo treated sites as it relates to the number of colony forming units (CFU's) over time after application and overall change in the microbiome diversity	9 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fluent in English, willing and able to read, understand, and sign the informed consent form
Ability to complete the course of the study and comply with instructions
Makes and Females ages 18-65 years, inclusively, in good general health as deemed by the investigator
Individuals with Fitzpatrick skin type I, II, III, IV
Individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, could interfere with the conduct of the study, interpretation of results or increase the risk of adverse reactions.
Females practicing an acceptable method of birth control

Exclusion Criteria:

individuals with any visible skin disease, skin condition including baseline erythema assessment > 0.5, or tattoos in the test area
individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness
individuals with recent prolonged sun or tanning bed exposure in the test area
individuals with excessive dryness or redness at the sites of application
individuals with a known hypersensitivity to cosmetic or personal care formulations
subjects must not have applied any lotions creams, powders, or oils to their backs the morning of the study. Additionally 2 hours must have passed since bathing or showering
women who are pregnant or nursing
individuals who have participated on a s study involving the test sites (back) in the previous 14 days
individuals participating in another clinical study
individuals with open or healing cuts/incisions abrasions, lesions, pustules, fissures or broken mucosa/skin in the test site

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided