A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 744
- 试验地点
- 22
- 主要终点
- Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
详细描述
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.
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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 12 through 45 years, inclusive, who is in good general health.
- •An ISGA score of 3 or greater at baseline.
- •Lesion counts meeting both of the following criteria:
- •Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions.
- •Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions.
- •Regular menstrual cycle prior to study entry for females of childbearing potential.
- •Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.
- •Women who are not currently sexually active must agree to use medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
- •Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- •Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
排除标准
- •Female who is pregnant, trying to become pregnant, or breast feeding.
- •Use of topical antibiotics on the face within the past 2 weeks.
- •Use of systemic antibiotics for acne treatment within the past 4 weeks.
- •Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity.
- •Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks.
- •Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
- •Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
- •Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks.
- •Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
- •Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable.
- •Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks.
- •Require or desire excessive or prolonged exposure to ultraviolet light during the study.
- •Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
- •A significant medical history of or currently immunocompromised.
- •Use of any investigational product within the past 4 weeks or currently participating in another clinical study.
- •Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
- •Any major illness within 30 days before study enrollment.
- •Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study
研究组 & 干预措施
1
Tazarotene foam, 0.1%
干预措施: Tazarotene foam (Drug)
2
Vehicle Foam
干预措施: Vehicle Foam (Drug)
结局指标
主要结局
Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
时间窗: Baseline (Week 0/Day 1) and Week 12
LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12
时间窗: Baseline (Week 0/Day 1) and Week 12
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: \>G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions \[NLs\]); 3=moderate S: \>G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
Number of Participants With an ISGA Score of 0 or 1 at Week 12
时间窗: Week 12
Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: \>G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions \[NLs\]); 3=moderate S: \>G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.
次要结局
- Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older(Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12)
- Change in Children's Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger(Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12)
- Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator(Baseline (Week 0/Day 1) to Week 12)
- Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator(Baseline (Week 0/Day 1) to Week 12)
- Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator(Baseline (Week 0/Day 1) to Week 12)
- Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants(Baseline (Week 0/Day 1) to Week 12)
- Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants(Baseline (Week 0/Day 1) to Week 12)
- Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12(Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12)
- Absolute Change From Baseline in LC at Weeks 2, 4, and 8(Baseline (Week 0/Day 1); Weeks 2, 4, and 8)
- Time to a 50 Percent Reduction in Total Lesion Counts (TLC)(Baseline (Week 0/Day 1) to Week 12)
- Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8(Baseline (Week 0/Day 1); Weeks 2, 4, and 8)
- Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8(Weeks 2, 4, and 8)
- Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12(Weeks 2, 4, 8, and 12)