NCT03559972已完成不适用
Open-Label, Randomized, Multi-center Study to Evaluate the Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change from Baseline in Clinical grading of the full face on the Griffith's modified 10-point scale
研究概览
简要总结
This study will assess the efficacy and tolerability of two topical regimens (containing cosmetic human fibroblast-derived, physiologically-balanced growth factor combination products (HULK and TNS Essential Serum)
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged 30 years and older with Fitzpatrick skin type I-VI
- •Pre-elected to receive on-label facial injection(s) (i.e. neuromodulator injection and/or filler injections)
- •Experienced injection patients defined as having received at least 1 facial injection in the past 2 years.
- •Current users of non-physician-dispensed brand skin care products (i.e. only using products that are available at drugstores or department stores
- •Good general health and free of any disease state or physical condition (e.g. psoriasis, rosacea, scars, tattoos etc.)
- •Willingness to have exams and digital photos performed on the face.
- •Willingness to cooperate and participate by following study requirements (including using the provided test products) for the duration of the study and to report any adverse event symptoms or reactions immediately.
- •Willingness to discontinue use of their current skincare products starting at their Week 4 visit in this study.
- •Willingness to not use any other products, including self-tanners, on their face for the duration of the study other than make-up with an established tolerance of at least 1 month.
- •Willingness to withhold all facial treatments during the course of the study including microdermabrasion, peels, facials, laser treatments and tightening treatments.
- •.Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Subjects are asked to wear protective clothing prior to and during exposure.
- •If of child-bearing potential, willing to use an acceptable method of contraception throughout the study. Acceptable methods of birth
排除标准
- •Who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- •Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study.
- •Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, active hepatitis, immune deficiency, or autoimmune.
- •Individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
- •Individuals who require electrolysis, waxing, or use depilatories on the face during conduct of the study.
- •Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
- •Individuals who are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion of the study.
- •Subjects currently on or planning to participate on any type of research study at another facility or a doctor's office during this study.
结局指标
主要结局
Change from Baseline in Clinical grading of the full face on the Griffith's modified 10-point scale
时间窗: Baseline, Week 4, Week 16
Investigator will assess the following parameters on a Griffith's modified 10-point scale (0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, 7 to 9 = Severe)
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
A Multi-Center, Open-label Study Evaluate the Efficacy and Tolerability of a Dual Skincare Regimen Treatment for Facial Hyperpigmentation and Photodamaged Skin in Patients Exposed to Extrinsic Factors of AgingPhotodamaged SkinWrinkleFine LinesHyperpigmentationNCT05423873Revision Skincare33
已完成
不适用
Clinical Case Series Evaluating Skin Wellness SystemMoisture-associated DermatitisFungal Infection in Perineal AreaNCT01724229GM Associates20
终止
4 期
A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated AppendicitisAppendicitisNCT00236912Johnson & Johnson Pharmaceutical Research & Development, L.L.C.139
已完成
不适用
To Evaluate the Effect of Moisturizing Creams on Skin Barrier FunctionDry SkinSkin CareNCT03804710GlaxoSmithKline158
已完成
2 期
A 48 Week Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)Non-infectious UveitisNCT04207983Eyevensys3