Back to resultsCosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
Primary Purpose
Atopic Dermatitis Eczema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AO+Mist
Placebo
Sponsored by
About this trial
This is an interventional other trial for Atopic Dermatitis Eczema
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- Medical Dermatology Associates of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
AO+Mist
Placebo
Arm Description
AO+Mist
Placebo
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
Secondary Outcome Measures
Difference in Atopic Dermatitis EASI score
Difference in Skindex16 Quality of Life survey
Difference in Skindex 16 Quality of Life Survey during Extension Period
Difference in EASI score during Extension Period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03268174
Brief Title
Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
February 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AOBiome LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a bilateral study. Each subject will apply appropriately labeled test product to the left and right arm.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
AO+ Mist (or placebo) are supplied in white 100mL metered spray bottles. Test products are blinded and labeled for application to the LEFT or RIGHT side of the body
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AO+Mist
Arm Type
Active Comparator
Arm Description
AO+Mist
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
AO+Mist
Intervention Description
Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain "AO+Mist".
Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain "AO+Mist".
Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
Time Frame
Baseline-Day 30
Secondary Outcome Measure Information:
Title
Difference in Atopic Dermatitis EASI score
Time Frame
Baseline-Day 30
Title
Difference in Skindex16 Quality of Life survey
Time Frame
Baseline-Day 30
Title
Difference in Skindex 16 Quality of Life Survey during Extension Period
Time Frame
Day 30-60
Title
Difference in EASI score during Extension Period
Time Frame
Day 30-60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Facility Information:
Facility Name
Medical Dermatology Associates of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
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