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

NCT03268174 | Completed

• 1 other identifier: AOB-2016-AD
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance

  Baseline-Day 30

Secondary Outcomes (4)

• 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

Study Arms (2)

AO+Mist

ACTIVE COMPARATOR

AO+Mist

Other: AO+Mist

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

AO+Mist OTHER

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.

AO+Mist

Placebo OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• AOBiome LLC: lead

Study Sites (1)

Medical Dermatology Associates of Chicago

Chicago, Illinois, 60654, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a bilateral study. Each subject will apply appropriately labeled test product to the left and right arm.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: May 11, 2016
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)