EUCTR2009-011212-37-PL进行中（未招募）不适用
Anti P. acnes activity of Epiduo® Gel compared to Benzoyl Peroxide 2.5% Gel in the treatment of subjects with acne vulgaris - Anti P. acnes - Epiduo - Acne
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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. Male or female Subjects of any race, aged 18 years or more,
- •2. Subjects with facial acne,
- •3. Subjects with high levels of P. acnes counts on the forehead (score of 3 according to a 4-point scale with 0 = no fluorescence and 3 = strong level of fluorescence) under Wood’s lamp,
- •4. Subjects with a minimum of 10 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,
- •5. Subjects with a minimum of 10 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose,
- •6. Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice an effective method of contraception during the study: oral/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
- •7. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,
- •8. Subjects have to read and sign the approved Informed Consent form prior to any participation in the study,
- •9. Subjects willing and capable of complying with requirements of the protocol visits and procedures.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with more than 1 nodule or cyst on the face,
- •2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
- •3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
- •4. Subjects with a wash-out period for topical treatment on the face less than (see table below):
- •- Corticosteroids, Antibiotics, Antibacterials, Antiseptics, Retinoids, other Anti-
- •Inflammatory treatments or other acne treatments 2 weeks
- •- Phototherapy devices for acne and cosmetic procedures (i.e., facials, peels,
- •comedone extraction) 1 week
- •5. Subjects with a wash-out period for systemic treatment less than (see table below):
- •Corticosteroids, Antibiotics 4 weeks
- •Other acne treatments (including isotretinoin) 6 months
- •Ciproterone acetate 6 months
- •Spironolactone 3 months
- •6. Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the Subjects at risk may confound the study results, or may interfere with the Subjects’ participation in the study,
- •7. Subjects who are at risk in terms of precautions, warnings, and contraindications (see Summary of Medicinal Product Characteristics (SmPC) / Investigational Medicinal Product Dossier (IMPD),
- •8. Subjects with known or suspected allergy to one of the test products (see Summary of Medicinal Product Characteristics (SmPC) / Investigational Medicinal Product Dossier (IMPD),
- •9. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,
- •10. Adult Subjects under guardianship, hospitalized Subjects in a public or private institution for a reason other than the research, and Subjects deprived of freedom,
- •11. Subjects with a beard or other facial hair that might interfere with study assessments,
- •12. Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
研究者
相似试验
已完成
4 期
Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% GelAcne VulgarisNCT01188538Galderma R&D40
已完成
4 期
A Treatment Regimen for Student Athletes With Mild to Moderate Acne VulgarisAcne VulgarisNCT02249104Galderma R&D28
招募中
3 期
Assessment of the efficacy of topical gel containing insulin and silver nanoparticles in the treatment of second-degree burn woundsIRCT20210918052511N3Mashhad University of Medical Sciences56
尚未招募
3 期
Study of the efficacy of of using Eucerin pro acne solution SOS serum and Eucerin pro acne solution 3X treatment gel to foam cleanser in mild acne vulgaris.Patient with mild acne vulgaris.acne vulgaris, acne treatmentTCTR20240523002Beiresdorf Thailand30
招募中
3 期
Evaluation of the Efficacy of Combined Topical Gel of Verapamil, Nitroglycerin and Lidocain in Prevention of Radial Artery Spasm IncidenceChronic Coronary Syndrome.Angina pectorisIRCT20200128046296N1Tehran University of Medical Sciences128