Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Doxycycline in Severe Inflammatory Acne (Non-Nodulocystic) Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Change in Number of Inflammatory Lesions
研究概览
简要总结
Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.
详细描述
This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and safety study was conducted in subjects with severe inflammatory acne. Subjects who met the inclusion criteria and none of the exclusion criteria at the Screening visit returned to the clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12 weeks.
Treatment consisted of 2 investigational study drugs:
- A/BPO 0.3%/2.5% gel applied to dry skin as directed by study staff once daily for 12 weeks, at night after washing.
- Doxycycline hyclate 200 mg: each subject was to take 2 50-mg tablets of doxycycline hyclate in the morning and 2 at night, for a total of 4 tablets (a total of 200 mg) daily for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 12 years of age or older at Screening visit.
- •Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4).
- •Subjects with 4 or fewer nodules or cysts > 1 cm in diameter on the face.
- •Subjects 18 years of age or older must read and sign the Informed Consent Form, which includes Photography Consent and HIPAA authorization, prior to any participation in the study. Consent will be obtained prior to any study-related procedures. Subjects under the age of 18 years must sign an Assent to Participate Form to participate in the study and must have one parent or guardian read and sign the Informed Consent Form prior to any study-related procedure. (The parent or guardian is not required to attend the following visits unless requested.)
排除标准
- •Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
- •Subjects with 5 or more acne nodules or cysts > 1 cm in diameter on the face at Screening and Baseline visits.
- •Female subjects who are pregnant, nursing, or planning a pregnancy during the study.
- •Subjects who have used any systemic therapy directed at improving acne, including antibiotics, within 30 days prior to Baseline visit.
- •Subjects who are at risk in terms of precautions, warnings, and contraindications for the investigational study drugs (see Appendix 14.1 for package inserts for adapalene 0.3%/benzoyl peroxide 2.5% gel and doxycycline hyclate Tablets).
- •Subjects with any other condition or circumstance which, in the Investigator's opinion, may put the subject at risk (e.g., a history of significant renal disease with impairment of renal function), confound the study results, or interfere with the subject's participation in the study.
- •Sponsor and study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.
研究组 & 干预措施
Acne treatment
Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks)
Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks)
干预措施: Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (Drug)
Acne treatment
Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks)
Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks)
干预措施: Oral doxycycline hyclate (Drug)
结局指标
主要结局
Change in Number of Inflammatory Lesions
时间窗: Week 12
Change in Number of Inflammatory Lesions from baseline.
次要结局
- Number and Percent of Adverse Events(Week 12)
- Number and Percent of Subjects With IGA Success(Weeks 4, 8, and 12)
- Percent Change From Baseline in Total Lesion Count(Weeks 4, 8, and 12)
- Change From Baseline in Total Lesion Count(Weeks 4, 8, and 12)
- Percent Change From Baseline in Inflammatory Lesion Count(Weeks 4, 8, and 12)
- Change From Baseline in Inflammatory Lesion Count(Weeks 4, 8, and 12)
- Percent Change From Baseline in Non-Inflammatory Lesion Count(Weeks 4, 8, and 12)
- Change From Baseline in Non-Inflammatory Lesion Count(Weeks 4, 8, and 12)
- Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates(Weeks 0, 4, 8, and 12)
- Subject Assessment of Acne Improvement(Week 12)