Acne VulgarisPhase 2NCT02537483
A Study Comparing the 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 and IDP-120 Component B in people with Acne Vulgaris, run by Valeant Pharmaceuticals.
Trial summary
The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- IDP-120 Gel, IDP-120 Component A and IDP-120 Component B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 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
- No healthy volunteers
- 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.
- Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits
- Subjects must be willing to comply with study instructions and return to the clinic for required visits.
Who cannot join
- Any dermatological conditions on the face that could interfere with clinical evaluations
- 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
- Subjects who are unable to communicate or cooperate with the Investigator
- Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study
Trial locations and contacts
No sites are listed yet.
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
The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.
Read the detailed description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.
- Conditions
- Acne Vulgaris
- Being tested
- IDP-120 Gel, IDP-120 Component A, IDP-120 Component B, 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
Investigational Product: IDP-120 Gel
IDP-120 Component ADrug
Comparator Product: IDP-120 Component A
IDP-120 Component BDrug
Comparator Product: IDP-120 Component B
IDP-120 Vehicle GelDrug
Comparator Product: IDP-120 Vehicle Lotion
| Study group | Role | What they receive |
|---|---|---|
| IDP-120 Gel | Experimental | IDP-120 Gel, applied topically to the face once daily for 12 weeks. Receives: Drug: IDP-120 Gel |
| IDP-120 Component A | Active comparator | IDP-120 Component A, applied topically to the face once daily for 12 weeks Receives: Drug: IDP-120 Component A |
| IDP-120 Component B | Active comparator | IDP-120 Component B, applied topically to the face once daily for 12 weeks Receives: Drug: IDP-120 Component B |
| IDP-120 Vehicle Gel | Placebo comparator | IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks Receives: Drug: IDP-120 Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face.
Inflammatory lesions are defined as follows:
Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin.
Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate.
Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter.
Measured: 12 weeks
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones).
Non-inflammatory lesions are defined as follows:
Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin.
Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance.
Measured: 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.
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions.
- Clear - Normal, clear skin with no evidence of acne vulgaris
- Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
- Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions)
- Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion
- Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.
Measured: 12 weeks
Secondary outcomes (3)
Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8.
At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the change will be calculated.
Measured: 2, 4, and 8 weeks
Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 2, 4, and 8 in the Evaluator's Global Severity Score
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions.
- Clear - Normal, clear skin with no evidence of acne vulgaris
- Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
- Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions)
- Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion
- Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.
Measured: 2, 4, and 8 weeks
Mean percent change in inflammatory and non-inflammatory lesion counts form baseline at Weeks 2, 4, 8, and 12.
At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the percent change will be calculated.
Measured: 2, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valeant Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, MS, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537483
- Sponsor's protocol ID
- V01-120A-201
- Status last verified
- Sep 2015
- First submitted
- 28 Aug 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. 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
- NCT02537483
- Acronym / sponsor ID
- V01-120A-201
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Valeant PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 1 Sep 2015 (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 primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.
Detailed description
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IDP-120 Gel | Experimental | Drug: IDP-120 GelIDP-120 Gel, applied topically to the face once daily for 12 weeks. |
| IDP-120 Component A | Active comparator | Drug: IDP-120 Component AIDP-120 Component A, applied topically to the face once daily for 12 weeks |
| IDP-120 Component B | Active comparator | Drug: IDP-120 Component BIDP-120 Component B, applied topically to the face once daily for 12 weeks |
| IDP-120 Vehicle Gel | Placebo comparator | Drug: IDP-120 Vehicle GelIDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not 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.
- Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
- Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits
- Subjects must be willing to comply with study instructions and return to the clinic for required visits.
Key exclusion criteria (5 listed)
- Any dermatological conditions on the face that could interfere with clinical evaluations
- 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
- Subjects who are unable to communicate or cooperate with the Investigator
- Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study
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 GelInvestigational Product: IDP-120 Gel | Drug | IDP-120 Gel |
| IDP-120 Component AComparator Product: IDP-120 Component A | Drug | IDP-120 Component A |
| IDP-120 Component BComparator Product: IDP-120 Component B | Drug | IDP-120 Component B |
| IDP-120 Vehicle GelComparator Product: IDP-120 Vehicle Lotion | Drug | IDP-120 Vehicle Gel |
Primary outcome
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
Time frame: 12 weeks
At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face. Inflammatory lesions are defined as follows: Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter.
Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Time frame: 12 weeks
At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones). Non-inflammatory lesions are defined as follows: Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin. Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance.
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.
Time frame: 12 weeks
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris 1. Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) 2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) 3. Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion 4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.
3 secondary outcomes
Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8.
Time frame: 2, 4, and 8 weeks
Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 2, 4, and 8 in the Evaluator's Global Severity Score
Time frame: 2, 4, and 8 weeks
Mean percent change in inflammatory and non-inflammatory lesion counts form baseline at Weeks 2, 4, 8, and 12.
Time frame: 2, 4, 8, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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, MS study director
Valeant Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDP-120 Gel, IDP-120 Component A and IDP-120 Component B in people with Acne Vulgaris, run by Valeant Pharmaceuticals.
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: status not confirmed, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anya Loncaric, MS (510-259-5284, aloncaric@solta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from Baseline to Week 12 in mean inflammatory lesion counts (time frame: 12 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 14 Sep 2015.