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.
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
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
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
Parallel
Social Renew
Other interventionThis group receives a cleanser, serum, and cream.
Placebo
Other interventionThis group receives a cleanser, serum, and cream.
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
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 Renew
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 10
The difference in the change in acne symptoms as assessed by the Acne Quality of Life Questionnaire (ACNE-QoL) between GenLabs' Social Renew
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 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
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 from baseline at Day 10. The SCARS has two parts, part 1 asks questions related to current active acne including zits, breakouts, pimpled, whiteheads, and blackheads, and questions related to atrophic scaring including indents or holes in the skin from previous active acne. Part 2 of the SCARS, assess acne scar appearance and severity with 5 questions such as how much of your face is covered by indents or holes with five potential answers: almost none of my face, a little of my face, some of my face, a lot of my face, and almost all of my face
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
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 from baseline at Day 20. The SCARS has two parts, part 1 asks questions related to current active acne including zits, breakouts, pimpled, whiteheads, and blackheads, and questions related to atrophic scaring including indents or holes in the skin from previous active acne. Part 2 of the SCARS, assess acne scar appearance and severity with 5 questions such as how much of your face is covered by indents or holes with five potential answers: almost none of my face, a little of my face, some of my face, a lot of my face, and almost all of my face
Self-reported incidence of post-emergent adverse events (AE)
Self-reported incidence of post-emergent adverse events (AE)
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GenCanna Acquisition Corp
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
