NCT01267149Unknown不适用
Phase 4 Study - A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
Goldman, Butterwick, Fitzpatrick and Groff2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 13
- 试验地点
- 2
研究概览
简要总结
Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines in the treated areas as compared to baseline.
Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas as compared to baseline.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males in good general health between 35 to 65 years of age.
- •Must be willing to give and sign a HIPPA form, informed consent form and a photographic release form
- •Patient is planning to undergo Prevelle Silk treatment
- •A potential subject's must exhibit:
- •A. moderate to severe superficial, vertical perioral and horizontal canthus lines
- •For FEMALE PATIENT OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
- •Negative urine pregnancy test results at the time of study entry (if applicable)
- •Must be willing to comply with study regimen and complete the entire course of the study.
排除标准
- •A patient with any UNCONTROLLED systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- •A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •A patient with a known hypersensitivity to any of the components of the study medications
- •A patient who is actively smoking or plans to smoke at any time of the duration of this study
- •A patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis)
- •A patient planning any other cosmetic procedure to their facial area during the study period, other than the treatments that will be performed by the investigator
- •A patient using any topical (prescription or over the counter) medicated creams, lotions, gels, balms, powders, etc. on the treatment areas during the study period
- •A patient receiving any topical products containing alpha-hydroxy acids, salicylic acid, and vitamins C or D (includes derivatives thereof) on the perioral or lateral canthal areas within 7 days prior to or during the study period, other than the study products
- •A patient receiving any investigational drug and/or has had a microdermabrasion (light or medium skin peel) treatment on their perioral or lateral canthal areas within 30 days prior to or during the study period
- •A patient using any topical tretinoin product or derivative on their perioral or lateral canthal areas within 12 weeks prior to or during the study period
- •A patient receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a Dermabrasion (deep skin peel) or ablative laser treatments on their perioral or lateral canthal areas must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study
- •A patient that has previously been treated with botulinum toxin in the perioral or lateral canthal areas within the past six months
- •A patient that has previously been treated with dermal filler in the perioral or lateral canthal areas within the past year
- •A patient that with a history of allergic reaction to a dermal filler or lidocaine
- •A patient that with a history of a permanent filler to the perioral or lateral canthal areas
- •A female patient who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)]
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
研究者
研究点 (2)
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