Clinical Evaluation of Efficacy at 2 Weeks of Duac® Fixed Dose Combination Gel in Treatment of Facial Acne Vulgaris in Japanese Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2
研究概览
简要总结
This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.
详细描述
Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.
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
- Single (Investigator)
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 and female subjects between 12 to 45 years of age, inclusive.
- •Subjects must have had both: (a) A minimum of 17 but not more than 60 ILs (papules / pustules) on the face, including nasal lesions; (b) A minimum of 20 but not more than 150 non-ILs (open / closed comedones) on the face, including nasal lesions.
- •Subjects who have an ISGA score of 2 or greater at Baseline.
- •Female subjects of childbearing potential and women who are less than 2 years from their last menses must agree to use contraception
- •Subjects who are willing and able to follow all study procedures and to visit all scheduled evaluation points.
- •Subjects who have ability to understand and give a written informed consent form (written informed consent must be obtained also from the parent or guardian if the participant is under 20 years of age).
排除标准
- •Subjects who have any nodulo-cystic lesions at Baseline.
- •Female subjects who are pregnant or who are breast-feeding.
- •Subjects who have a history or presence of regional enteritis, inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, antibiotic-associated colitis or bloody diarrhoea) or similar symptoms.
- •Subjects who used any of the following agents within 2 weeks prior to Baseline: topical antibiotics on the face or systemic antibiotics; topical anti-acne medications (e.g. Benzoyl peroxide, azelaic acid, resorcinol, salicylates etc.); abradants, facials, peels, masks containing glycolic or other acids; washes, soaps, non mild facial cleansers containing benzoyl peroxide, salicylic acid or sulfacetamide sodium; moisturizers containing retinol, salicylic acid or alpha or beta-hydroxy acids (except additive agent); astringents and toner.
- •Subjects who used any of the following agents on the face or performed the following procedure within 4 weeks prior to baseline: topical corticosteroids applied onto face (use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable); facial procedure (such as chemical and laser peel, microdermabration, blue light treatment, etc.).
- •Subjects who used systemic retinoids within the previous 6 months or topical retinoids within 6 weeks prior to Baseline.
- •Subjects who received treatment with estrogens, androgens or anti-androgenic agents within the previous 12 weeks (subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug or discontinue use during the study).
- •Subjects who are using any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
- •Subjects who plan to use medications that are reported to exacerbate acne (such as vitamin D and vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium, hydantoin and Phenobarbital).
- •Subjects who have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
- •Subjects who have used investigate therapy within the previous 12 weeks or plan to participate in another clinical study at the same time.
- •Subjects who participated in another Japanese clinical study planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
- •Subjects with a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening.
- •Subjects who have medical history suggestive of an immunocompromized status.
- •Subjects who are employees of a GlaxoSmithKline, an investigator or clinical research organization involved in the study or any immediate family member of an employee involved in the study.
- •Subjects who have any other condition that would put the subject at unacceptable risk for participation in the study.
研究组 & 干预措施
Duac® fixed dose combination gel
Subjects will use Duac® fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
干预措施: Duac® fixed dose combination gel (Drug)
Combination therapy: ADA 0.1% gel + CLDM 1% gel
Subjects will use combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and subjects will also apply CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel should apply subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel should be applied to ILs only.
干预措施: ADA 0.1% gel (Drug)
Combination therapy: ADA 0.1% gel + CLDM 1% gel
Subjects will use combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and subjects will also apply CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel should apply subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel should be applied to ILs only.
干预措施: CLDM 1% gel (Drug)
结局指标
主要结局
Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2
时间窗: Baseline (Day 1) and Week 2
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
次要结局
- Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12(Baseline (Day 1) and Week 1, 2, 4, 8, 12)
- Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12(Up to Week 12)
- Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12(Week 1, 2, 4, 8 and 12)
- Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12(Week 1, 2, 4, 8 and 12)
- Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging(Week 1, 2, 4, 8 and 12)
- Number of Participants With Severity of AEs(Up to Week 12)
- Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12(Baseline (Day 1) and Week 1, 4, 8, 12)
- Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12(Baseline (Day 1) and Week 1, 2, 4, 8, 12)
- Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12(Week 1, 2, 4, 8, 12)
- Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12(Week 1, 2, 4, 8 and 12)
- Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12(Week 1, 2, 4, 8 and 12)
- Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12(Baseline(Day 1) and Week 2, 4, 8 and 12)
- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 12)