AcnePhase 1NCT02850003
Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel
A Phase 1 study testing IDP-120 Gel in people with Acne, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Acne
- What is being tested?
- IDP-120 Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Nov 2016
- Phase
- Phase 1
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female between the ages of 9 and <17 (16 years 11 months)
- 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 legal guardian must sign the informed consent.
- Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
- Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
- Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.
Who cannot join
- Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, 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 conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
- Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.
- Subjects with a facial beard or mustache that could interfere with the study assessments
- Subjects with more than 2 facial nodules.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions
Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.
Read the detailed description
An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.
- Conditions
- Acne
- Being tested
- IDP-120 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 Gel
Gel
| Study group | Role | What they receive |
|---|---|---|
| IDP-120 Gel | Experimental | Gel Receives: Drug: IDP-120 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluators Global Severity Score At Day 15
Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02850003
- Sponsor's protocol ID
- V01-120A-501
- Status last verified
- Sep 2017
- First submitted
- 6 Jul 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions
- ClinicalTrials.gov ID
- NCT02850003
- Acronym / sponsor ID
- V01-120A-501
- Conditions
- Acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Jul 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.
Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.
Detailed description
An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDP-120 Gel | Experimental | Drug: IDP-120 GelGel |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female between the ages of 9 and <17 (16 years 11 months)
- 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 legal guardian must sign the informed consent.
- Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
- Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
- Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.
Key exclusion criteria (5 listed)
- Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, 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 conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
- Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.
- Subjects with a facial beard or mustache that could interfere with the study assessments
- Subjects with more than 2 facial nodules.
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: GelGel | Drug | IDP-120 Gel |
Primary outcome
Evaluators Global Severity Score At Day 15
Time frame: 15 Days
Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).
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 25 Sep 2017.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDP-120 Gel in people with Acne, run by Bausch Health Americas, Inc. 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 5 inclusion and 5 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 25 Sep 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluators Global Severity Score At Day 15 (time frame: 15 Days). 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 25 Sep 2017.