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

NCT03243617 | Completed

• 1 other identifier: AOB2015-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratosis Pilaris

Outcome Measures

Primary Outcomes (1)

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

  Baseline-Week 4

Secondary Outcomes (1)

• Difference in Keratosis pilaris Investigator Score

  Baseline-Week 4

Other Outcomes (1)

• Difference in Skindex16 Quality of Life survey

  Baseline-Week 4

Study Arms (2)

AO+Mist

ACTIVE COMPARATOR

Cosmetic Product AO+Mist

Other: Placebo; Other: AO+Mist

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo; Other: AO+Mist

Interventions

Placebo OTHER

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

AO+Mist; Placebo

AO+Mist OTHER

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

AO+Mist; Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female subjects ≥18 and ≤65 years of age
• Subject is in good general health
• Diagnosis of keratosis pilaris involving areas of the body affected bilaterally
• Subject has Fitzpatrick Skin Type I-VI
• Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face.
• Ability to comprehend and comply with 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:

• Male and female subjects under 18 years or over 65 years of age
• Female subjects who are pregnant or lactating
• Subjects who have received laser therapy to the KP affected area in the past 1 year
• Subjects with a concurrent diagnosis of another skin condition or malignancy
• Subjects with tan or sunburn over the area affected by KPin the past month
• Subjects with open, non-healing sores or infections at any skin site
• 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.
• Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to baseline
• Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to baseline
• Prescription topical retinoid use on the face or body within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene).
• 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..
• 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)
• Subjects who are unable to understand the protocol or give informed consent
• 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)

Sponsors & Collaborators

• AOBiome LLC: lead

Study Sites (1)

Skincare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Study Officials

• Jeffrey Dover, MD

  Skincare Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• 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: Bi-Lateral study

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 9, 2017
• Study Start: December 4, 2015
• Primary Completion: June 8, 2016
• Study Completion: September 3, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)