NCT07127523尚未招募不适用
A Randomized, Triple-blind, Placebo Controlled, Parallel Virtual Clinical Trial to Investigate the Efficacy and Safety of GenLabs' Social Renew on Improving Acne Symptoms and Skin Repair Among Healthy Adults
GenCanna Acquisition Corp2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew and placebo
研究概览
简要总结
The goal of this interventional clinical trial is to investigate the efficacy and safety of GenLabs' Social Renew on improving acne symptoms and skin repair among healthy adults. The main question[s] it aims to answer is:
What is the difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew and placebo from baseline at Day 30.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Males and females between 18 and 65 years of age inclusive
- •Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- •Individuals of child-bearing potential must self-report confirmation they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Abstinence
- •Experience acne on facial skin that is visible to the participant and is confirmed by the QI at screening and at baseline
- •Willingness to complete questionnaires and diaries associated with the study, to capture and upload photos, and to complete all virtual visits
- •Willingness to maintain the same skincare regimen throughout the study, including maintaining make-up routine without the addition of new make-up products
- •Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- •Provided voluntary, written, informed consent to participate in the study
- •Agrees to have de-identified photos of face available for marketing purposes
- •Self-reported healthy as determined by medical history with no unstable diagnosed medical conditions
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Self-reported allergy, sensitivity or intolerance to investigational product or placebo ingredients, including allergy to salicylic acid or any form of salicylates, preventing topical use
- •Individuals with significant facial hair that would impede the visualization of facial acne and may interfere with the use of the product, such as beards and long sideburns, as assessed by the QI
- •Self-reported psoriasis, dermatitis, vitiligo, or any other active dermatological condition other than acne affecting the face
- •Self-reported use of topical products on the face marked with claims relating to skin health, or those with claims relating to acne during the study, except for noncomedogenic moisturizers and sunscreen
- •Self-reported shaving, waxing, tweezing, or threading of the face or use of nose/facial strips within 3 days prior to each photo capture
- •Procedures such as microdermabrasion, peels, acne treatments, filler, botulinum toxin, red light therapy, pore suction therapy, or laser on the face within three months of baseline
- •Self-reported UVA or UVB exposure to the face in the past two weeks or expected during the study to avoid sunburn.
- •Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
- •Self-reported asthma
- •Self-reported presence of a peptic ulcer
- •Self-reported autoimmune disease or are immune compromised
- •Self-reported ongoing and unstable diseases/conditions in the past three months, including:
- •Arthritis and joint diseases
- •Gastrointestinal diseases
- •Hypertension
- •Type I or type II diabetes
- •Cardiovascular disease
- •Kidney diseases
- •Liver diseases
- •Thyroid condition
- •Psychiatric conditions
- •Major surgery in the past 3 months or individuals who have planned surgery during the course of the study
- •Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- •Alcohol intake average of >2 standard drinks per day
- •Alcohol or drug abuse within the last 12 months
- •Participation in other clinical research studies 30 days prior to screening
- •Individuals who are unable to give informed consent
- •Any other condition or lifestyle factor that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
研究组 & 干预措施
Placebo
Placebo Comparator
This group receives a placebo containing non-medicinal ingredients in Social Renew, in a three-step skin regime. Apply the 3 study products in the morning and at night before bed. The participants will be required to maintain their application times throughout the study duration. Application of the study products covering the face will occur in a step-wise fashion (Step 1, Step 2, Step 3) for 30 days.
干预措施: Placebo (Other)
结局指标
主要结局
The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew and placebo
时间窗: Day 0 to 30
The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew and placebo from baseline at Day 30. The Acne symptoms domain of the Acne-QoL is comprised of 5 questions which assess the physical symptoms experienced by facial acne sufferers. Questions include the number of bumps on the face, the extent of scabbing from the acne, and the level of worry associated with scarring from the acne.
The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Skin and placebo
时间窗: Day 0 to 30
The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Skin and placebo from baseline at Day 30. The Acne symptoms domain of the Acne-QoL is comprised of 5 questions which assess the physical symptoms experienced by facial acne sufferers. Questions include the number of bumps on the face, the extent of scabbing from the acne, and the level of worry associated with scarring from the acne.
次要结局
- The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew(Day 0 to 10)
- The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew(Day 0 to 20)
- The difference in change in acne symptoms as assessed by the Self-assessment of Clinical Acne-Related Scars (SCARS) between GenLabs' Social Renew and placebo(Day 0 to 10)
- The difference in change in acne symptoms as assessed by the Self-assessment of Clinical Acne-Related Scars (SCARS) between GenLabs' Social Renew and placebo(Day 0 to 20)
- The difference in change in acne symptoms as assessed by the Self-assessment of Clinical Acne-Related Scars (SCARS) between GenLabs' Social Renew and placebo(Day 0 to 30)
- The difference in change in self-perception, social impact, and emotional impact as measured by the ACNE-QoL between GenLabs' Social Renew and placebo(Day 0 to 10)
- The difference in change in self-perception, social impact, and emotional impact as measured by the ACNE-QoL between GenLabs' Social Renew and placebo(Day 0 to 20)
- The difference in change in self-perception, social impact, and emotional impact as measured by the ACNE-QoL between GenLabs' Social Renew and placebo(Day 0 to 30)
- The difference in change in acne appearance as assessed by the participant and investigator using the Global Aesthetic Improvement Scale (GAIS) between GenLabs' Social Renew and placebo(Day 0 to 10)
- The difference in change in acne appearance as assessed by the participant and investigator using the Global Aesthetic Improvement Scale (GAIS) between GenLabs' Social Renew and placebo(Day 0 to 20)
- The difference in change in acne appearance as assessed by the participant and investigator using the Global Aesthetic Improvement Scale (GAIS) between GenLabs' Social Renew and placebo(Day 0 to 30)
- The difference in change in acne scar appearance as assessed by the participant using the Vancouver Scar Scale (VSS) between GenLabs' Social Renew and placebo(Day 0 to 10)
- The difference in change in acne scar appearance as assessed by the participant using the Vancouver Scar Scale (VSS) between GenLabs' Social Renew and placebo(Day 0 to 20)
- The difference in change in acne scar appearance as assessed by the participant using the Vancouver Scar Scale (VSS) between GenLabs' Social Renew and placebo(Day 0 to 30)
- The difference in change in acne scar appearance as assessed by the participant using the Vancouver Scar Scale (VSS) between GenLabs' Social Skin and placebo(Day 0 to 30)
- The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Skin(Day 0 to 20)
- The difference in change in acne symptoms as assessed by the Self-assessment of Clinical Acne-Related Scars (SCARS) between GenLabs' Social Skin and placebo(Day 0 to 30)
- The difference in change in self-perception, social impact, and emotional impact as measured by the ACNE-QoL between GenLabs' Social Skin and placebo(Day 0 to 30)
- The difference in change in acne appearance as assessed by the participant and investigator using the Global Aesthetic Improvement Scale (GAIS) between GenLabs' Social Skin and placebo(Day 0 to 30)
研究者
研究点 (2)
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