Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
- Conditions
- Acne
- Interventions
- Drug: IDP-121 Vehicle LotionDrug: IDP 121 Lotion
- Registration Number
- NCT02965456
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score \[EGSS\] of 3 \[moderate\] or 4 \[severe\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 820
- Male or female at least 9 years of age and older.
- Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
- Participants must be willing to comply with study instructions and return to the study center for required visits. Participants 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, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant wears makeup they must agree to use non-comedogenic makeup.
Key
- 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.
- Participants with a facial beard or mustache that could interfere with the study assessments.
- History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
- Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
- Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDP-121 Vehicle Lotion IDP-121 Vehicle Lotion IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks. IDP-121 Lotion IDP 121 Lotion IDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 Baseline (Day 0), Week 12 Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 Baseline, Week 12 Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Percentage of Participants With Treatment Success at Week 12 Baseline, Week 12 Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Inflammatory Lesion Count to Week 12 Baseline, Week 12 Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 Baseline, Week 12 Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
Trial Locations
- Locations (34)
Valeant Site 21
🇺🇸Glendale, Arizona, United States
Valeant Site 25
🇺🇸Anaheim, California, United States
Valeant Site 18
🇺🇸Beverly Hills, California, United States
Valeant Site 17
🇺🇸Murrieta, California, United States
Valeant Site 26
🇺🇸Oxnard, California, United States
Valeant Site 22
🇺🇸Sacramento, California, United States
Valeant Site 02
🇺🇸San Diego, California, United States
Valeant Site 04
🇺🇸San Diego, California, United States
Valeant Site 19
🇺🇸Santa Monica, California, United States
Valeant Site 15
🇺🇸Miami, Florida, United States
Valeant Site 31
🇺🇸Sanford, Florida, United States
Valeant Site 27
🇺🇸Pinellas Park, Florida, United States
Valeant Site 05
🇺🇸Tampa, Florida, United States
Valeant Site 28
🇺🇸Marietta, Georgia, United States
Valeant Site 16
🇺🇸Buffalo Grove, Illinois, United States
Valeant Site 06
🇺🇸Indianapolis, Indiana, United States
Valeant Site 12
🇺🇸Overland Park, Kansas, United States
Valeant Site 03
🇺🇸Detroit, Michigan, United States
Valeant Site 30
🇺🇸Clarkston, Michigan, United States
Valeant Site 08
🇺🇸New York, New York, United States
Valeant Site 23
🇺🇸Winston-Salem, North Carolina, United States
Valeant Site 29
🇺🇸Hazleton, Pennsylvania, United States
Valeant Site 24
🇺🇸Johnston, Rhode Island, United States
Valeant Site 10
🇺🇸Austin, Texas, United States
Valeant Site 33
🇺🇸Port Arthur, Texas, United States
Valeant Site 01
🇺🇸Houston, Texas, United States
Valeant Site 07
🇺🇸San Antonio, Texas, United States
Valeant Site 13
🇺🇸San Antonio, Texas, United States
Valeant Site 14
🇺🇸San Antonio, Texas, United States
Valeant Site 20
🇺🇸Henderson, Nevada, United States
Valeant Site 34
🇺🇸Rogers, Arkansas, United States
Valeant Site 32
🇺🇸Crowley, Louisiana, United States
Valeant Site 11
🇺🇸Miami, Florida, United States
Valeant Site 09
🇺🇸Fremont, California, United States