Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
Status: | Completed |
---|---|
Conditions: | Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/1/2017 |
Start Date: | May 11, 2016 |
End Date: | February 13, 2017 |
A Placebo-Controlled, Double-Blind, Bilateral Cosmetic Study With an Open Label Extension to Evaluate the Performance of a Cosmetic Product Designed to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
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
the appearance of arm skin in subjects with atopic dermatitis
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.
Subjects will undergo a 2 week washout period prior to the Baseline procedure. Follwoing the
Baseline visit assessments, subjects will be asked to apply "AO+ Mist" or placebo to the
affected area of the arm twice a day (morning and night) for 30 days.
After the 30 day initial study period, subjects will automatically be rolled over to
participate in the extension of the trial for another 30 days using only AO+Mist on the body
parts affected by Atopic Dermatitis.
Atopic Dermatitis affecting both sides of the body. Up to 20 subjects will be enrolled to
participate.
Subjects will undergo a 2 week washout period prior to the Baseline procedure. Follwoing the
Baseline visit assessments, subjects will be asked to apply "AO+ Mist" or placebo to the
affected area of the arm twice a day (morning and night) for 30 days.
After the 30 day initial study period, subjects will automatically be rolled over to
participate in the extension of the trial for another 30 days using only AO+Mist on the body
parts affected by Atopic Dermatitis.
Inclusion Criteria:
1. Male and female subjects ≥18
2. 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
3. Subjects should have similar presentation and severity of AD on both arms
4. Ability to comprehend and comply with study procedures
5. Agree to commit to participate in the current protocol
6. 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 Criteria:
1. Female subjects who are pregnant or lactating or who are trying to conceive
2. 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
3. Any skin condition which in the investigator's opinion may interfere with the
evaluation of Atopic Dermatitis
4. Severe cases of AD that present with pustules and weeping and those cases that require
urgent medical attention
5. 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)
6. Hypersensitivity to AO+Mist or its components
7. Seropositive for human immunodeficiency virus (HIV) by medical history review at
screening
8. Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus
antibody (HCV Ab) by medical history review at screening
9. 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)
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