Acne VulgarisPhase 2/3NCT02832063
Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris
A Phase 2/3 study testing B244 in people with Acne Vulgaris, 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 B244 administered over 12 weeks to participants with mild to moderate acne vulgaris relative to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- B244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 19 Jul 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for enrollment in the study must meet all the following criteria:
- Male and females age 18 or older
- Clinical diagnosis of mild to moderate facial acne vulgaris defined as:
- ≥5 inflammatory lesions, and;
- ≥10 non-inflammatory lesions, and;
- IGA 2-3
- Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne. Topical acne treatments that do not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) are allowed for treatment of non-facial acne.
- Willing and able to provide informed consent and to comply with the study protocol.
Who cannot join
- Pregnant and/or lactating females
- Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
- Active cystic acne or acne conglobata, acne fulminans, and secondary acne
- Two or more active nodular lesions
- 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, or topical probiotics including commercially available product AO+Mist on the face within 7 days prior to baseline.
- Treatment with systemic corticosteroids within 28 days prior to baseline.
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- Treatment with systemic antibiotics or systemic anti-acne drugs within 7 days prior to baseline.
- Prescription topical retinoid use on the face within 7 days of baseline (e.g., tretinoin, tazarotene, adapalene).
- Commencement of new hormonal therapy or dose change to hormonal therapy within 90 days prior to baseline. Dose and frequency of use of any hormonal therapy started more than 90 days prior to baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
- Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
- Oral retinoid use (e.g., isotretinoin) within 180 days prior to baseline or vitamin A supplements greater than 10,000 units/day within 180 days of baseline.
- Cosmetic facial procedures (chemical or laser peel, microdermabrasion, etc.) within the 28 days of the first dose or during the study.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- Any condition that the study Investigator feels would indicate that participation would not be in the best interest of the participant.
- The participant has been previously randomized in this study.
- The participant has received an investigational product within 30 days or 5 half-lives, whichever is longer prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blinded, Phase IIb/III, Decentralized Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Participants With Mild to Moderate Acne Vulgaris
The purpose of this study is to demonstrate the safety, tolerability and efficacy of B244 administered over 12 weeks to participants with mild to moderate acne vulgaris relative to placebo.
Read the detailed description
This is a Phase IIb/III, randomized, double blinded, decentralized clinical trial evaluating the safety, tolerability, and efficacy of B244 compared to placebo in the treatment of acne vulgaris
1.1. Primary Objectives
- To evaluate the safety and tolerability of B244 in participants with acne vulgaris
- To assess the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to week 12 (end of treatment) by:
- Reduction in inflammatory and non-inflammatory lesion count ii) IGA success
- Improvement in patient reported quality of life score using the Skindex-16 questionnaire in participants with acne vulgaris from baseline to week 12
1.2. Secondary Objectives 1. To evaluate the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to weeks 2, 4, 8, and 16: i) Reduction in inflammatory and non-inflammatory lesion count ii) IGA success iii) Improvement in patient reported quality of life score using the Skindex-16 questionnaire
1.3. Exploratory Objective
- To evaluate facial skin microbiota in participants with acne vulgaris at baseline, week 4, week 8, week 12, and week 16 in B244-treated participants compared to placebo from: i) Skin swabs will be taken from forehead, nose, both cheeks and chin All participants (placebo and B244) will undergo skin swabs and testing.
- Conditions
- Acne Vulgaris
- Being tested
- B244, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B244Biological
4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
PlaceboBiological
4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| B244 arm | Active comparator | B244 dose administered in a 1:1 (active vs placebo) ratio Receives: Biological: B244 |
| Placebo arm | Placebo comparator | Placebo dose administered in a 1:1 (active vs placebo) ratio Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment RelatedAdverse Events
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Measured: 16 weeks
Change in Inflammatory and Non-inflammatory Lesion Count
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Measured: 12 weeks
Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
Measured: 12 weeks
Secondary outcomes (3)
Change in Inflammatory and Non-inflammatory Lesion Count by Week
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Measured: Baseline to weeks 2, 4, 8, 12 and 16
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
Measured: Baseline to weeks 2, 4, 8, 12 and 16
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire
The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
Measured: Baseline to weeks 2, 4, 8, 12 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, Science 37
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832063
- Sponsor's protocol ID
- AVB244-002
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2016
- Last updated
- 16 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Phase IIb/III, Decentralized Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Participants With Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02832063
- Acronym / sponsor ID
- AVB244-002
- Conditions
- Acne Vulgaris
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Posted 16 Sep 2022
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 B244 administered over 12 weeks to participants with mild to moderate acne vulgaris relative to placebo.
Detailed description
This is a Phase IIb/III, randomized, double blinded, decentralized clinical trial evaluating the safety, tolerability, and efficacy of B244 compared to placebo in the treatment of acne vulgaris
1.1. Primary Objectives
- To evaluate the safety and tolerability of B244 in participants with acne vulgaris
- To assess the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to week 12 (end of treatment) by:
- Reduction in inflammatory and non-inflammatory lesion count ii) IGA success
- Improvement in patient reported quality of life score using the Skindex-16 questionnaire in participants with acne vulgaris from baseline to week 12
1.2. Secondary Objectives 1. To evaluate the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to weeks 2, 4, 8, and 16: i) Reduction in inflammatory and non-inflammatory lesion count ii) IGA success iii) Improvement in patient reported quality of life score using the Skindex-16 questionnaire
1.3. Exploratory Objective
- To evaluate facial skin microbiota in participants with acne vulgaris at baseline, week 4, week 8, week 12, and week 16 in B244-treated participants compared to placebo from: i) Skin swabs will be taken from forehead, nose, both cheeks and chin All participants (placebo and B244) will undergo skin swabs and testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B244 arm | Active comparator | Biological: B244B244 dose administered in a 1:1 (active vs placebo) ratio |
| Placebo arm | Placebo comparator | Biological: PlaceboPlacebo dose administered in a 1:1 (active vs placebo) ratio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and females age 18 or older
- Clinical diagnosis of mild to moderate facial acne vulgaris defined as:
- Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne. Topical acne treatments that do not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) are allowed for treatment of non-facial acne.
- Willing and able to provide informed consent and to comply with the study protocol.
Key exclusion criteria (16 listed)
- Pregnant and/or lactating females
- Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
- Active cystic acne or acne conglobata, acne fulminans, and secondary acne
- Two or more active nodular lesions
- 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, or topical probiotics including commercially available product AO+Mist on the face within 7 days prior to baseline.
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 |
|---|---|---|
| B2444 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks. | Biological | B244 arm |
| Placebo4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks. | Biological | Placebo arm |
Primary outcome
Number of Participants With Treatment RelatedAdverse Events
Time frame: 16 weeks
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Change in Inflammatory and Non-inflammatory Lesion Count
Time frame: 12 weeks
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success
Time frame: 12 weeks
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
3 secondary outcomes
Change in Inflammatory and Non-inflammatory Lesion Count by Week
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Noah Craft, MD principal investigator
Science 37
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing B244 in people with Acne Vulgaris, 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 16 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 16 Sep 2022. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 RelatedAdverse Events (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 16 Sep 2022.