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

GenCanna Acquisition Corp

Status: Not yet enrolling

Conditions: Acne

Treatments: Other: Social Skin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07127523

25GCCFT01

Details and patient eligibility

About

The goal of this interventional clinical trial is to investigate the efficacy and safety of GenLabs' Social Skin 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 Skin and placebo from baseline at Day 30.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females between 18 and 65 years of age inclusive

2. 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

3. Experience acne on facial skin that is visible to the participant and is confirmed by the QI at screening and at baseline

4. Willingness to complete questionnaires and diaries associated with the study, to capture and upload photos, and to complete all virtual visits

5. Willingness to maintain the same skincare regimen throughout the study, including maintaining make-up routine without the addition of new make-up products

6. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study

7. Provided voluntary, written, informed consent to participate in the study

8. Agrees to have de-identified photos of face available for marketing purposes

9. Self-reported healthy as determined by medical history with no unstable diagnosed medical conditions

Exclusion criteria

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

2. 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

3. 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

4. Self-reported psoriasis, dermatitis, vitiligo, or any other active dermatological condition other than acne affecting the face

5. 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

6. Self-reported shaving, waxing, tweezing, or threading of the face or use of nose/facial strips within 3 days prior to each photo capture

7. 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

8. Self-reported UVA or UVB exposure to the face in the past two weeks or expected during the study to avoid sunburn.

9. 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)

10. Self-reported asthma

11. Self-reported presence of a peptic ulcer

12. Self-reported autoimmune disease or are immune compromised

13. Self-reported ongoing and unstable diseases/conditions in the past three months, including:

    1. Arthritis and joint diseases
    2. Gastrointestinal diseases
    3. Hypertension
    4. Type I or type II diabetes
    5. Cardiovascular disease
    6. Kidney diseases
    7. Liver diseases
    8. Thyroid condition
    9. Psychiatric conditions

14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study

15. 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

16. Alcohol intake average of >2 standard drinks per day

17. Alcohol or drug abuse within the last 12 months

18. Participation in other clinical research studies 30 days prior to screening

19. Individuals who are unable to give informed consent

20. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Social Skin

Experimental group

Description:

The investigational product in this study contains ProRenew Complex CLRTM, which is a three-step skin regime targeting acne comprised of Lactococcus ferment lysate, derived from L. lactis, in addition to peppermint, willow bark, and lentil seed extracts. 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 and neck will occur in a step-wise fashion (Step 1, Step 2, Step 3) for 30 days.

Treatment:

Other: Social Skin

Placebo

Placebo Comparator group

Description:

This group receives a placebo containing non-medicinal ingredients in Social Skin, 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 and neck will occur in a step-wise fashion (Step 1, Step 2, Step 3) for 30 days.

Treatment:

Other: Placebo