A Clinical Trial to Investigate the Efficacy and Safety of GenLabs' Social Renew on Improving Acne Symptoms and Skin Repair Among Healthy Adults

Официальное название

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

Обзор

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.

Вмешательства

• Другое Social Renew
  This group receives a cleanser, serum, and cream.
• Другое Placebo
  This group receives a cleanser, serum, and cream.

Первичные конечные точки

• 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 [Срок оценки: Day 0 to 30]

Вторичные конечные точки (12)

• The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Day 0 to 10]

Критерии участия

Критерии включения

• 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

Or,

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• KGK Science Inc. — London

Идентификаторы

NCT: NCT07127523 · 25GCCFT01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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