Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.

Not Applicable

Completed

• Conditions: Atopic Dermatitis Eczema
• Interventions: Other: Placebo; Other: AO+Mist

• Registration Number: NCT03268174
• Lead Sponsor: AOBiome LLC

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.

Study Timeline

• Study Start: 2016-05-11
• Primary Completion: 2017-02-13
• Study Completion: 2017-02-13
• Status Verified: 2017-08
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-08-31
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
AO+Mist	AO+Mist	AO+Mist

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance	Baseline-Day 30

Secondary Outcome Measures

Name	Time	Method
Difference in Atopic Dermatitis EASI score	Baseline-Day 30
Difference in Skindex16 Quality of Life survey	Baseline-Day 30
Difference in Skindex 16 Quality of Life Survey during Extension Period	Day 30-60
Difference in EASI score during Extension Period	Day 30-60

Trial Locations

Locations (1)

Medical Dermatology Associates of Chicago; 🇺🇸 Chicago, Illinois, United States