Acne VulgarisPhase 2NCT01293552
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
A Phase 2 study testing ANT-1207 in people with Acne Vulgaris, run by Anterios Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ANT-1207
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of moderate to severe facial acne
- 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
- no presence of nodules
- female subjects must be not pregnant and non-lactating
Who cannot join
- presence of 1 or more nodules
- use of topical steroids on the face 4 weeks prior and during the study
- use of systemic corticosteroids 6 weeks prior and during the study
- topical or systemic acne treatment in the 4 weeks prior to Baseline
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
DermResearch, Inc.
Austin, Texas, 78759
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
Penn State Hershey Medical Center Department of Dermatology
Hershey, Pennsylvania, 17033
Dermatology Consulting Services
High Point, North Carolina, 27262
The Skin Wellness Center
Knoxville, Tennessee, 37922
Dermatology Specialists Research, LLC
Louisville, Kentucky, 40202
William Coleman III, MD, APMC
Metairie, Louisiana, 70006
International Dermatology Research
Miami, Florida, 33144
Gramercy Park Dermatology
New York, New York, 10010
Skin Search of Rochester, Inc
Rochester, New York, 14623
Gwinnett Clinical Research Center Inc.
Snellville, Georgia, 30078
The Dermatology Group, P.C.
Verona, New Jersey, 07044
Grekin Skin Institute
Warren, Michigan, 48088
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, 33401
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
About this study
Official title: Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.
- Conditions
- Acne Vulgaris
- Being tested
- ANT-1207, Vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-1207Biological
single dose application
VehicleBiological
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | blank vehicle formulation Receives: Biological: Vehicle |
| Dose 1 | Experimental | Dose 1 Receives: Biological: ANT-1207 |
| Dose 2 | Experimental | Dose 2 Receives: Biological: ANT-1207 |
| Dose 3 | Experimental | Dose 3 Receives: Biological: ANT-1207 |
| Dose 4 | Experimental | Dose 4 Receives: Biological: ANT-1207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be assessed by lesion count.
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)
Measured: Week 4
Secondary outcomes (2)
Change from Baseline in Investigator Global Assessment Score
Measured: Week 1, 2, 4, 8, and 12
Change from Baseline in Lesion Count
Measured: Week 1, 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterios Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293552
- Sponsor's protocol ID
- ANT-1207-101-ACNE
- Status last verified
- Jun 2013
- First submitted
- 9 Feb 2011
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne
- ClinicalTrials.gov ID
- NCT01293552
- Acronym / sponsor ID
- ANT-1207-101-ACNE
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Anterios Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Feb 2011 (estimated)
- 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 provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Biological: Vehicleblank vehicle formulation |
| Dose 1 | Experimental | Biological: ANT-1207Dose 1 |
| Dose 2 | Experimental | Biological: ANT-1207Dose 2 |
| Dose 3 | Experimental | Biological: ANT-1207Dose 3 |
| Dose 4 | Experimental | Biological: ANT-1207Dose 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of moderate to severe facial acne
- 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
- no presence of nodules
- female subjects must be not pregnant and non-lactating
Key exclusion criteria (4 listed)
- presence of 1 or more nodules
- use of topical steroids on the face 4 weeks prior and during the study
- use of systemic corticosteroids 6 weeks prior and during the study
- topical or systemic acne treatment in the 4 weeks 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 |
|---|---|---|
| ANT-1207single dose application | Biological | Dose 1, Dose 2, Dose 3, Dose 4 |
| VehicleAlso: Placebo | Biological | Control |
Primary outcome
Efficacy will be assessed by lesion count.
Time frame: Week 4
inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones)
2 secondary outcomes
Change from Baseline in Investigator Global Assessment Score
Time frame: Week 1, 2, 4, 8, and 12
Change from Baseline in Lesion Count
Time frame: Week 1, 2, 4, 8, 12
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 4 Jul 2013.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANT-1207 in people with Acne Vulgaris, run by Anterios Inc. at 15 sites 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 4 inclusion and 4 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 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy will be assessed by lesion count. (time frame: 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 4 Jul 2013.