Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
Completed · Not applicable · Has a placebo group
Conditions studied: Atopic Dermatitis Eczema
In brief
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
Key facts
- Study ID
- NCT03268174
- Run by
- AOBiome LLC
- People needed
- 19
- Starts
- 2016-05-11
- Expected to finish
- 2017-02-13
- Last updated by the study team
- 2017-08-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Medical Dermatology Associates of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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