Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
- Registration Number
- NCT02932306
- 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).
- Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit
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, gram-negative 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (39)
Valeant Site 28
🇺🇸Hot Springs, Arkansas, United States
Valeant Site 03
🇺🇸Albuquerque, New Mexico, United States
Valeant Site 33
🇺🇸Needham, Massachusetts, United States
Valeant 18
🇺🇸Webster, Texas, United States
Valeant Site 26
🇺🇸New York, New York, United States
Valeant Site 21
🇺🇸Norfolk, Virginia, United States
Valeant Site 38
🇺🇸Fountain Valley, California, United States
Valeant Site 20
🇺🇸San Diego, California, United States
Valeant Site 37
🇺🇸Miami, Florida, United States
Valeant Site 39
🇺🇸Pembroke Pines, Florida, United States
Valeant Site 01
🇺🇸West Palm Beach, Florida, United States
Valeant Site 19
🇺🇸Boise, Idaho, United States
Valeant Site 04
🇺🇸Arlington Heights, Illinois, United States
Valeant Site 27
🇺🇸Carmel, Indiana, United States
Valeant Site 11
🇺🇸Warren, Michigan, United States
Valeant Site 13
🇺🇸Berlin, New Jersey, United States
Valeant Site 31
🇺🇸Stony Brook, New York, United States
Valeant Site 30
🇺🇸Houston, Texas, United States
Valeant Site 07
🇺🇸San Antonio, Texas, United States
Valeant Site 14
🇺🇸Phoenix, Arizona, United States
Valeant Site 29
🇺🇸Salt Lake City, Utah, United States
Valeant Site 36
🇺🇸Guntersville, Alabama, United States
Valeant Site 23
🇺🇸Oceanside, California, United States
Valeant Site 34
🇺🇸Manhattan Beach, California, United States
Valeant Site 10
🇺🇸Shelton, Connecticut, United States
Valeant Site 15
🇺🇸Coral Gables, Florida, United States
Valeant 12
🇺🇸Plainfield, Indiana, United States
Valeant Site 06
🇺🇸Dallas, Texas, United States
Valeant 05
🇺🇸Gresham, Oregon, United States
Valeant Site 22
🇺🇸Fort Washington, Pennsylvania, United States
Valeant Site 17
🇺🇸Pflugerville, Texas, United States
Valeant Site 35
🇺🇸Rancho Cucamonga, California, United States
Valeant Site 02
🇺🇸Boynton Beach, Florida, United States
Valeant Site 32
🇺🇸Denver, Colorado, United States
Valeant Site 09
🇺🇸Louisville, Kentucky, United States
Valeant Site 16
🇺🇸Louisville, Kentucky, United States
Valeant Site 08
🇺🇸Omaha, Nebraska, United States
Valeant Site 25
🇺🇸Omaha, Nebraska, United States
Valeant Site 24
🇺🇸Charleston, South Carolina, United States