NCT04096742Unknown4 期
A Prospective, Randomized, Double-blind, Vehicle-controlled Study Evaluating the Efficacy, Safety and Patient Satisfaction of Tretinoin 0.05% Lotion (Altreno) for Chest Rejuvenation.
Goldman, Butterwick, Fitzpatrick and Groff1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Skin Quality
研究概览
简要总结
This is a single-center, prospective, double-blind, randomized, vehicle-controlled study to evaluate the efficacy, safety and patient satisfaction of tretinoin 0.05% lotion (Altreno) for chest rejuvenation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females or males age 18-65, Fitzpatrick skin types I-VI
- •Moderate to severe photodamage (Fitzpatrick Wrinkle score of 4-9)
- •Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
- •Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
- •Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
- •Women of childbearing potential willing to use an acceptable form of birth control during trial period.
- •Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
- •Intrauterine coil
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- •Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
- •Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
- •Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.
排除标准
- •Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
- •Known hypersensitivity or allergy to the components of the study medication.
- •Concurrent enrollment in any study involving the use of investigational devices or drugs.
- •Current smoker or history of smoking in the last five years.
- •Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- •Presence of an active systemic or local skin disease that may affect treatment area.
- •History of prior surgery to the treatment area
- •History of prior significant trauma to the chest
- •History of the following cosmetic treatments to the area(s) to be treated:
- •Energy based device or laser procedure to the chest within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
- •Injectable filler of any type to the chest in the past 2 years (Hyaluronic acid fillers (Voluma, Belotero), Poly-L-Lactic acid fillers (e.g. Sculptra), and CaHA fillers (e.g. Radiesse)
- •Ever for permanent fillers (e.g. Silicone, ArteFill)
- •Surgical dermabrasion or chemical peels in the treatment area within the past 6 month
- •Any planned surgical intervention to the chest for the duration of the trial
- •Any visible surface alteration to the chest that may interfere with evaluation, at investigator discretion
- •Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion
- •Inability to comply with all study protocols and regulations
- •Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
- •Unwilling to minimize exposure to sunlight and sunlamps during the course of the study.
研究组 & 干预措施
Altreno
Experimental
tretinoin 0.05% lotion (Altreno)
干预措施: tretinoin 0.05% lotion (Altreno) (Drug)
Vehicle
Sham Comparator
Vehicle lotion not containing tretinoin
干预措施: Vehicle (Other)
结局指标
主要结局
Skin Quality
时间窗: Baseline through Month 6
Nine-point scale to assess skin quality for the appearance of crepiness, coarse lines/wrinkles, skin texture, and skin tone evenness
次要结局
- Investigator Assessment-Investigator Percent Improvement Evaluation(1, 3, and 6 months)
- Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS)(Baseline through Month 6)
- Investigator Assessment-Investigator Global aesthetic improvement scale (I-GAIS)(1, 3, and 6 months)
- Subject Assessments-Subject Global aesthetic improvement scale (S-GAIS)(1, 3, and 6 months)
- Subject Assessments-End of study patient questionnaire(Month 6)
- Subject Assessments-Patient satisfaction score(1, 3, and 6 months)
研究者
研究点 (1)
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