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

Atopic Dermatitis Eczema Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268174
• Other study ID #: AOB-2016-AD
• Status: Completed
• Phase: N/A
• First received: August 29, 2017
• Last updated: August 30, 2017
• Start date: May 11, 2016
• Est. completion date: February 13, 2017

Study information

• Verified date: August 2017
• Source: AOBiome LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 13, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• AO+Mist
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Medical Dermatology Associates of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AOBiome LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance		Baseline-Day 30
Secondary	Difference in Atopic Dermatitis EASI score		Baseline-Day 30
Secondary	Difference in Skindex16 Quality of Life survey		Baseline-Day 30
Secondary	Difference in Skindex 16 Quality of Life Survey during Extension Period		Day 30-60
Secondary	Difference in EASI score during Extension Period		Day 30-60