Status:
COMPLETED
Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
Lead Sponsor:
AOBiome LLC
Conditions:
Atopic Dermatitis Eczema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on the appearance of arm skin in subjects with atopic dermatitis
Detailed Description
This is a single center, double-blind, bilateral, placebo-controlled study in subjects with Atopic Dermatitis affecting both sides of the body. Up to 20 subjects will be enrolled to participate. Subj...
Eligibility Criteria
Inclusion
- Male and female subjects ≥18
- In good general health as determined by a thorough medical history i. Visible flexural dermatitis ii. Personal history of flexural dermatitis iii. Personal history of dry skin in the past 12 months
- Subjects should have similar presentation and severity of AD on both arms
- Ability to comprehend and comply with study procedures
- Agree to commit to participate in the current protocol
- Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
Exclusion
- Female subjects who are pregnant or lactating or who are trying to conceive
- Any clinically relevant abnormality identified on the screening history or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
- Any skin condition which in the investigator's opinion may interfere with the evaluation of Atopic Dermatitis
- Severe cases of AD that present with pustules and weeping and those cases that require urgent medical attention
- Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
- Hypersensitivity to AO+Mist or its components
- Seropositive for human immunodeficiency virus (HIV) by medical history review at screening
- Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) by medical history review at screening
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected test product non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Key Trial Info
Start Date :
May 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03268174
Start Date
May 11 2016
End Date
February 13 2017
Last Update
August 31 2017
Active Locations (1)
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1
Medical Dermatology Associates of Chicago
Chicago, Illinois, United States, 60654