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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03268174
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Other: AO+Mist Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a bilateral study. Each subject will apply appropriately labeled test product to the left and right arm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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
Primary Purpose: Other
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.
Actual Study Start Date : May 11, 2016
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : February 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Eczema

Arm Intervention/treatment
Active Comparator: AO+Mist
AO+Mist
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 Comparator: Placebo
Placebo
Other: 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.




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance [ Time Frame: Baseline-Day 30 ]

Secondary Outcome Measures :
  1. Difference in Atopic Dermatitis EASI score [ Time Frame: Baseline-Day 30 ]
  2. Difference in Skindex16 Quality of Life survey [ Time Frame: Baseline-Day 30 ]
  3. Difference in Skindex 16 Quality of Life Survey during Extension Period [ Time Frame: Day 30-60 ]
  4. Difference in EASI score during Extension Period [ Time Frame: Day 30-60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268174


Locations
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United States, Illinois
Medical Dermatology Associates of Chicago
Chicago, Illinois, United States, 60654
Sponsors and Collaborators
AOBiome LLC
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Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT03268174    
Other Study ID Numbers: AOB-2016-AD
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases