Safety Study of AZT-04 for Cosmetic Use

NCT03820076 | Completed

• 1 other identifier: AZT04-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Study of Three Doses of AZT-04 for Skin Appearance

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Bacterial Count

  9 days

Study Arms (3)

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

AZT-04 OTHER

Staphylococcus epidermidis

dose 1; dose 2; dose 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azitra Inc.: lead
• RCTs: collaborator

Study Sites (1)

RCTS, Inc.

Irving, Texas, 75062, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: January 17, 2019
• Primary Completion: January 21, 2019
• Study Completion: July 31, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

US (1)