Keratosis PilarisNCT03243617
Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris
A study testing AO+Mist in people with Keratosis Pilaris, run by AOBiome LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keratosis Pilaris
- What is being tested?
- AO+Mist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2015to 3 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Skincare Physicians
Chestnut Hill, Massachusetts, 02467
About this study
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
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.
Read the 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.
- Conditions
- Keratosis Pilaris
- Being tested
- Placebo, AO+Mist
- Medical subject headings
- Burnett Schwartz Berberian syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
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+MistOther
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
| Study group | Role | What they receive |
|---|---|---|
| AO+Mist | Active comparator | Cosmetic Product AO+Mist Receives: Other: Placebo; Other: AO+Mist |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo; Other: AO+Mist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
Measured: Baseline-Week 4
Secondary outcomes (1)
Difference in Keratosis pilaris Investigator Score
Measured: Baseline-Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start4 Dec 2015
- Primary completion8 Jun 2016
- Study completion3 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis PilarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bi-Lateral study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Dover, MD, Principal investigator, Skincare Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243617
- Sponsor's protocol ID
- AOB2015-02
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03243617
- Acronym / sponsor ID
- AOB2015-02
- Conditions
- Keratosis Pilaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 3 Sep 2016 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Bi-Lateral study
| Arm | Type | Receives |
|---|---|---|
| AO+Mist | Active comparator | Other: Placebo, Other: AO+MistCosmetic Product AO+Mist |
| Placebo | Placebo comparator | Other: Placebo, Other: AO+MistPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects 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, Placebo |
| AO+MistSubjects 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, Placebo |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
Time frame: Baseline-Week 4
1 secondary outcome
Difference in Keratosis pilaris Investigator Score
Time frame: Baseline-Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Keratosis Pilaris
Recruiting
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
Keratosis Pilaris (KP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Dover, MD principal investigator
Skincare Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AO+Mist in people with Keratosis Pilaris, run by AOBiome LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance (time frame: Baseline-Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.