EUCTR2017-001575-23-Outside-EU/EEA进行中（未招募）1 期
Clinical evaluation of efficacy at 2 weeks of Duac fixed dose combination gel in treatment of facial acne vulgaris in Japanese Subjects.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects 12 to 45 years (inclusive) of age
- •2. Subjects must have both:
- •A) A minimum of 17 but not more than 60 inflammatory lesions (papules / pustules) on the face, including nasal lesions.
- •B) A minimum of 20 but not more than 150 non- inflammatory lesions (open / closed comedones) on the face, including nasal lesions.
- •3. An Investigator’s Static Global Assessment (ISGA: global assessment of severity by the investigator) score of 2 or greater at Baseline.
- •4. The ability to understand and give a written informed consent form (Written informed consent must be obtained also from the parent or guardian if the subject is under 20 years of age).
- •5. Females of childbearing potential and women who are less than 2 years from their last menses must agree to use the following contraception [Hatcher 2007(a); Hatcher 2007(b)]:
- •? Abstinence;
- •Oral Contraceptive (either combined or progestogen alone), injectable progestogen, implants of levonorgestrel, or estrogenic vaginal ring (as long as the subject has been on treatment for more than 12 consecutive weeks prior to start of investigational product use);
- •? Intrauterine device (IUD) or intrauterine system (IUS);
- •? Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- •? Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
- •6. The ability and willingness to follow all study procedures and to visit all scheduled evaluation points.
- •Male and Female subjects
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 130
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 219
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have any nodulo-cystic lesions at Baseline.
- •2. Are pregnant or breast-feeding.
- •3. Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, antibiotic-associated colitis or bloody diarrhea) or similar symptoms.
- •4. Have a medical history suggestive of an immunocompromised status.
- •5. 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., BPO, azelaic acid, resorcinol, salicylates etc.)
- •? Abradants, facials, peels, masks containing glycolic or other acids
- •? Washes, soaps, non-mild facial cleansers containing BPO, salicylic acid, or sulfacetamide sodium
- •? Moisturizers that contain retinol, salicylic acid, or a- or ß-hydroxy acids (except additive agent)
- •? Astringents and toner
- •6. Used 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 or laser peel, microdermabration, blue light treatment, etc.)
- •7. Used systemic retinoids within the previous 6 months or topical retinoids within 6 weeks prior to baseline.
- •8. 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).
- •9. Using any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
- •10. Plan to use medications that are reported to exacerbate acne (e.g., vitamin D, vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium, hydantoin, and phenobarbital).
- •11. Have a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening.
- •12. Have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
- •13. Used any investigational therapy within the previous 12 weeks, or plan to participate in another clinical study at the same time.
- •14. Participated in another Japanese clinical studies planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
- •15. Are employees of GlaxoSmithKline, an investigator, or contract research organization (CRO) involved in the study, or any immediate family member of an employee involved in the study.
- •16. Have other conditions that would put the subject at unacceptable risk for participation in the study.
研究者
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