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

NCT07127523 | Not Yet Recruiting

• 1 other identifier: 25GCCFT01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne

Keywords

GenLabs; Social Skin; Acne symptoms

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Day 0 to 30

Secondary Outcomes (14)

• 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 10

• 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 10

• 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 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

Other Outcomes (1)

• Self-reported incidence of post-emergent adverse events (AE)

  Day 0 to 30

Study Arms (2)

Social Skin

EXPERIMENTAL

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.

Other: Social Skin

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Social Skin OTHER

This group receives a cleanser, serum, and cream.

Social Skin

Placebo OTHER

This group receives a cleanser, serum, and cream.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenCanna Acquisition Corp: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-08

Locations

CA (1)