- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537483
A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IDP-120 Gel
IDP-120 Gel, applied topically to the face once daily for 12 weeks.
|
Investigational Product: IDP-120 Gel
|
ACTIVE_COMPARATOR: IDP-120 Component A
IDP-120 Component A, applied topically to the face once daily for 12 weeks
|
Comparator Product: IDP-120 Component A
|
ACTIVE_COMPARATOR: IDP-120 Component B
IDP-120 Component B, applied topically to the face once daily for 12 weeks
|
Comparator Product: IDP-120 Component B
|
PLACEBO_COMPARATOR: IDP-120 Vehicle Gel
IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks
|
Comparator Product: IDP-120 Vehicle Lotion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
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. |
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.
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8.
Time Frame: 2, 4, and 8 weeks
|
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.
|
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
|
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
|
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
|
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.
|
2, 4, 8, and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V01-120A-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
-
Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingModerate to Severe Acne VulgarisChina
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
Clinical Trials on IDP-120 Gel
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.Completed
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Canada
-
Bausch Health Americas, Inc.Completed
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States, Belgium, Canada
-
Dow Pharmaceutical SciencesUnknownPlaque PsoriasisUnited States