Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris

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: NCT03243617
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
AOBiome LLC

Brief Summary:
The purpose of this study is to demonstrate the safety, tolerability and efficacy of AO+ Mist administered daily for 4 weeks to improve the appearance of skin afflicted with keratosis pilaris.

Condition or disease Intervention/treatment Phase
Keratosis Pilaris Other: Placebo Other: AO+Mist Not Applicable

Detailed Description:

This will be a single center, double-blind, placebo-controlled study in subjects with keratosis pilaris affecting both sides of the body.

Subjects will be screened within 4 weeks of enrollment. Subjects will be seen at the research facility on for the baseline visit and will be asked to return to the site on weeks 1, 2, 3 and 4 for assessments. Test product application will occur for four weeks starting with the day of the baseline visit.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Bi-Lateral study
Masking: Double (Participant, Care Provider)
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, Bi-Lateral Study to Evaluate the Performance and Tolerability of a Cosmetic Product Designed to Improve the Appearance of Skin Afflicted With Keratosis Pilaris
Actual Study Start Date : December 4, 2015
Actual Primary Completion Date : June 8, 2016
Actual Study Completion Date : September 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

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

Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:

  • LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • Subjects may not wash their body with soap and water AFTER the applications

Other: AO+Mist

Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:

  • LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • Subjects may not wash their body with soap and water AFTER the applications

Placebo Comparator: Placebo
Placebo
Other: Placebo

Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:

  • LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • Subjects may not wash their body with soap and water AFTER the applications

Other: AO+Mist

Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:

  • LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
  • Subjects may not wash their body with soap and water AFTER the applications




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance [ Time Frame: Baseline-Week 4 ]

Secondary Outcome Measures :
  1. Difference in Keratosis pilaris Investigator Score [ Time Frame: Baseline-Week 4 ]

Other Outcome Measures:
  1. Difference in Skindex16 Quality of Life survey [ Time Frame: Baseline-Week 4 ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects ≥18 and ≤65 years of age
  2. Subject is in good general health
  3. Diagnosis of keratosis pilaris involving areas of the body affected bilaterally
  4. Subject has Fitzpatrick Skin Type I-VI
  5. Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face.
  6. Ability to comprehend and comply with procedures
  7. Agree to commit to participate in the current protocol
  8. 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. Male and female subjects under 18 years or over 65 years of age
  2. Female subjects who are pregnant or lactating
  3. Subjects who have received laser therapy to the KP affected area in the past 1 year
  4. Subjects with a concurrent diagnosis of another skin condition or malignancy
  5. Subjects with tan or sunburn over the area affected by KPin the past month
  6. Subjects with open, non-healing sores or infections at any skin site
  7. Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid, including lactic acid lotions (Am-Lactin, Lac-Hydrin), urea cream (Carmol 10, Carmol 20, Carmol 40, Urix 40), salicylic acid (Salex lotion), topical corticosteroids within 4 weeks prior to baseline.
  8. Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to baseline
  9. Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to baseline
  10. Prescription topical retinoid use on the face or body within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene).
  11. Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline..
  12. Treatment with any investigational drug within 30 days prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
  13. Subjects who are unable to understand the protocol or give informed consent
  14. Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication 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): NCT03243617


Locations
Layout table for location information
United States, Massachusetts
Skincare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
AOBiome LLC
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey Dover, MD Skincare Physicians
Layout table for additonal information
Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT03243617    
Other Study ID Numbers: AOB2015-02
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratosis, Actinic
Abnormalities, Multiple
Darier Disease
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn