Acne VulgarisPhase 2NCT03003247
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
A Phase 2 study testing IDP-120 Gel, IDP 120 Component A Gel and IDP 120 Component B Gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 24 sites in 2 countries.
Trial summary
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- IDP-120 Gel, IDP 120 Component A Gel and IDP 120 Component B Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Nov 2015to 30 Sep 2016
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female at least 9 years of age and older;
- Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
- Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
- If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.
Who cannot join
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- Subjects with a facial beard or mustache that could interfere with the study assessments.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States20 sites
Valeant Site 21
Atlanta, Georgia, 30302
Valeant Site 07
Austin, Texas, 73301
Valeant Site 12
Austin, Texas, 78701
Valeant Site 01
Chapel Hill, North Carolina, 27517
Valeant Site 22
Columbus, Ohio, 43085
Valeant Site 09
Detroit, Michigan, 48204
Valeant Site 15
Encino, California, 91316
Valeant Site 17
High Point, North Carolina, 27268
Valeant Site 04
Knoxville, Tennessee, 37901
Valeant Site 13
Lake Mary, Florida, 32746
Valeant Site 16
Miami, Florida, 33101
Valeant Site 24
Minneapolis, Minnesota, 55401
Valreant Site 05
New York, New York, 10001
Valeant Site 06
New York, New York, 10002
Valeant Site 11
Saint Joseph, Missouri, 64502
Valeant Site 18
San Antonio, Texas, 78204
Valeant Site 23
South Bend, Indiana, 46601
Valeant Site 25
Spokane, Washington, 99202
Valeant Site 14
Tampa, Florida, 33601
Valeant Site 02
West Palm Beach, Florida, 33401
Canada4 sites
Valeant Site 03
Markham, Ontario, L3P 0A1
Valeant Site 08
Waterloo, Ontario, N2J 1L9
Valeant Site 20
Windsor, Ontario, N9A 2S6
Valeant Site 10
Winnepeg, Manitoba, R2C 0A1
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Read the detailed description
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- IDP-120 Gel, IDP 120 Component A Gel, IDP 120 Component B Gel, IDP 120 Vehicle Gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-120 GelDrug
Also called Component A + B
IDP-120 Gel is a combination product
IDP 120 Component A GelDrug
Also called Component A
Monad of Component A
IDP 120 Component B GelDrug
Also called Component B
Monad of Component B
IDP 120 Vehicle GelDrug
Also called Vehicle
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| IDP-120 Gel | Experimental | IDP-120 Gel is a combination treatment Receives: Drug: IDP-120 Gel |
| IDP-120 Component A Gel | Active comparator | IDP-120 Monad Gel of Component A Receives: Drug: IDP 120 Component A Gel |
| IDP-120 Component B Gel | Active comparator | IDP-120 Monad Gel of Component B Receives: Drug: IDP 120 Component B Gel |
| IDP-120 Vehicle Gel | Placebo comparator | IDP-120 Vehicle Gel Receives: Drug: IDP 120 Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startNov 2015
- Primary completion31 Aug 2016
- Study completion30 Sep 2016
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.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003247
- Sponsor's protocol ID
- V01-120A-201
- Status last verified
- Dec 2017
- First submitted
- 6 May 2016
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03003247
- Acronym / sponsor ID
- V01-120A-201
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 26 Dec 2016 (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.
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Detailed description
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IDP-120 Gel | Experimental | Drug: IDP-120 GelIDP-120 Gel is a combination treatment |
| IDP-120 Component A Gel | Active comparator | Drug: IDP 120 Component A GelIDP-120 Monad Gel of Component A |
| IDP-120 Component B Gel | Active comparator | Drug: IDP 120 Component B GelIDP-120 Monad Gel of Component B |
| IDP-120 Vehicle Gel | Placebo comparator | Drug: IDP 120 Vehicle GelIDP-120 Vehicle Gel |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 9 years of age and older;
- Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
- Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
- If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.
Key exclusion criteria (4 listed)
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.
- Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- Subjects with a facial beard or mustache that could interfere with the study assessments.
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 |
|---|---|---|
| IDP-120 GelAlso: Component A + BIDP-120 Gel is a combination product | Drug | IDP-120 Gel |
| IDP 120 Component A GelAlso: Component AMonad of Component A | Drug | IDP-120 Component A Gel |
| IDP 120 Component B GelAlso: Component BMonad of Component B | Drug | IDP-120 Component B Gel |
| IDP 120 Vehicle GelAlso: VehicleVehicle | Drug | IDP-120 Vehicle Gel |
Primary outcome
Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
Time frame: 12 Weeks
Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.
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 18 Dec 2017.
- Individual participant dataSharing planned: Yes
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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.
Anya Loncaric study director
Valeant Pharmaceuticals
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDP-120 Gel, IDP 120 Component A Gel and IDP 120 Component B Gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 24 sites in 2 countries.
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 5 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 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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?
Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score. (time frame: 12 Weeks). 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 18 Dec 2017.