EUCTR2008-002359-26-DE进行中（未招募）不适用
A multi-center, randomized, evaluator-blind, parallel group study evaluation of the efficacy, safety, and tolerability of DUAC® Akne Gel and Epiduo® Gel in the topical treatment of facial acne vulgaris
Stiefel Laboratories0 个研究点开始时间: 2008年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 who are males or females 12 to 45 years of age, inclusive, in good general health.
- •2. Subjects who are capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed. NOTE - Subjects under 18 years of age must provide assent and have the written, informed consent of the parent(s) or legal guardian responsible for their custody.
- •3. Subjects who are willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
- •4. Subjects who have: A minimum of 25 to a maximum of 80 inflammatory facial lesions (papules and pustules), including the nose, and no facial nodular cystic lesions. AND A minimum of 12 to a maximum of 100 non-inflammatory facial lesions (open and closed comedones), excluding the nasal area.
- •5. Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, double-barrier methods, or condom plus spermatocide) for more than 12 consecutive weeks prior to start of study treatment and are allowed to enroll only if they do not expect to change dose, drug, or discontinue using contraception during the study.
- •6. Subjects who have been treated with estrogens, androgens, or anti?androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
- •7. Subjects who have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female subjects who are pregnant, trying to become pregnant, or who are lactating.
- •2. Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- •3. Subjects who have facial hair that may obscure the accurate assessment of acne grade.
- •4. Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- •5. Subjects who have used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
- •6. Subjects who have used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra?articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- •7. Subjects who have used systemic retinoids within the past 6 months.
- •8. Subjects who are using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- •9. Subjects who are using neuromuscular blocking agents. Clindamycin
- •has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- •10. Subjects who have used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
- •11. Subjects who have used any investigational therapy within 4 weeks of study day 1.
- •12. Subjects who are using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or a- or ß-hydroxy acids.
- •13. Subjects who are using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments.
- •14. Subjects who have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
- •15. Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
- •16. Subjects who are employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee, the investigator, or his/her study staff.
- •17. Subjects who have a member of the same household in this study.
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