NCT07136766Enrolling By Invitation3 期
An 18 Week Study to Assess the Efficacy of a Test Product Used in Combination With a Currently Marketed Prescription Product
Good Molecules, LLC1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Skin Lightness
研究概览
简要总结
The purpose of this study is to assess the efficacy (ability to produce a desired or intended result) of a topical product (applied to the skin) to improve skin lightness, skin condition and appearance (hyperpigmentation [dark spots], brightness/radiance [healthy vibrant appearance], skin texture [smoothness]) on ] the face over a period of eighteen (18) weeks. The data collected may support the company in developing marketing claims for its product.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals with facial hyperpigmentation and/or melasma.
- •Individuals willing to use a generic 4% Hydroquinone prescription topical cream up to 10 weeks for the duration of the study.
- •Individuals willing to refrain from use of other drugs or skincare intended to treat hyperpigmentation, other than study-specific products (prescription drug, test product, SPF 50) for the duration of the study.
- •Individuals who are able to cooperate with the Principal Investigator and study personnel throughout the duration of the study and are willing to comply with all study procedures, methods, evaluations, and study product use.
- •Individuals who are able to read, understand and willing to sign an informed consent for this specific study and have completed all site required documentation prior to study enrollment (Registration and Medical History).
- •Individuals who are able to receive emails on their cellular phones and are capable of completing electronic Informed Consents, Photo Model Releases, and/or Questionnaires on their device.
- •Individuals willing to be photographed and sign a model release.
排除标准
- •Individuals with known allergies and/or reactions to Hydroquinone.
- •Individuals currently participating in other clinical studies that are testing a face product.
- •Individuals with uncontrolled medical condition(s), including dermatological problems, which could put them at risk in the opinion of the Principal Investigator or compromise the study outcome and/or chronic or serious diseases and conditions which would prevent participation in this clinical study such as cancer, AIDS, insulin-dependent diabetes, renal impairment, mental illness, and/or drug/alcohol addiction.
- •Individuals with a history of melanoma, or a treated skin cancer within the last 5 years.
- •Individuals who are pregnant, lactating, or planning to become pregnant. Individuals who become pregnant during the study must inform the Principal Investigator immediately.
- •Individuals who are unreliable or unlikely to be available for the duration of the study.
- •Individuals with a history of allergic reactions, skin sensitization and/or known allergies to cosmetic and personal care products/ingredients.
- •Individuals who are immunocompromised.
- •Individuals who are employees of VCS, other testing firms/laboratories, consumer product, and/or raw goods manufacturers/suppliers.
- •Individuals who are unable to communicate or cooperate with the Principal Investigator/study personnel due to language problems, poor mental development, or impaired cerebral function.
- •Individuals who started hormones within the last three months preceding the commencement of the study.
- •Individuals who are using oral contraception for less than three months before study commencement or who have changed their contraceptive method within the three months before the Baseline visit or planning to modify their contraception treatment within the duration of the study.
- •Individuals who have regular salon and/or dermatological procedures that can interfere with study results (Microdermabrasion, Fillers, Facial Peels, etc.) and are not willing to stop throughout the study.
- •Individuals with facial tattoos and facial piercings (that can't be removed).
- •Individuals with tattooed/permanent make up (i.e., eyeliner, eyebrows, lip liner, etc.), eyebrow microblading, and/or eyelash extensions.
- •Individuals who plan to change their hairstyle throughout the course of the study or who wear hair coverings regularly (i.e., wigs, coloring, extensions, etc.).
研究组 & 干预措施
Test Product
Experimental
干预措施: Facial Toner (Drug)
Control Product
Sham Comparator
干预措施: Placebo Toner (Other)
结局指标
主要结局
Skin Lightness
时间窗: 18 weeks
L\* and Individual Typology Angle
次要结局
- Facial Hyperpigmentation(18 weeks)
- Facial Skin Texture(18 weeks)
- Facial Brightness/Radiance(18 weeks)
- Volunteer's opinion on product(18 weeks)
- Facial skin changes via images(18 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusJPRN-jRCT2071210076Hibi Kazushige36
已完成
不适用
Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal WomenFemale Dry Genital MucosaNCT02434887Kley Hertz S/A26
招募中
Unknown
A study for examination of effectiveness and feasibility of a personalized dementia prevention program based on individual risk factorsFactors influencing health status and contact with health servicesKCT0009437Seoul National University Hospital90
已完成
3 期
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DMDiabetes Mellitus, Type 1NCT00760526Jaeb Center for Health Research146
进行中（未招募）
1 期
To Assess Effectiveness of a Nurse initiated intervention on reducing the postnatal complications.CTRI/2020/06/025616ational Institute Of Nursing Education