Safety Study of AZT-04 for Cosmetic Use

Completed · Not applicable

Conditions studied: Study of Three Doses of AZT-04 for Skin Appearance

In brief

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

Key facts

Study ID

NCT03820076

Run by

Azitra Inc.

People needed

21

Starts

2019-01-17

Expected to finish

2019-07-31

Last updated by the study team

2020-07-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• RCTS, Inc. — Irving, Texas, United States

Full record on ClinicalTrials.gov

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