A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 820
- 试验地点
- 39
- 主要终点
- Percentage of Participants With Treatment Success at Week 12
研究概览
简要总结
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]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: IDP-121 Lotion (Drug)
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.
干预措施: IDP-121 Vehicle Lotion (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Success at Week 12
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Percent Change From Baseline in Noninflammatory Lesion Count to Week 12(Baseline, Week 12)
- Percent Change From Baseline in Inflammatory Lesion Count to Week 12(Baseline, Week 12)