Genesis Clinical Program
Personalized Stem Cell-Derived Topical Treatment for Hair, Skin, and Scars
About the Study
A multi-site prospective observational study of your personalized stem cell derived topical product for post-procedure skin healing, hair density improvement and scar reduction.
Your personalized treatment is made from your own stem cells, designed to perfectly match your body, support the recovery of your skin post-procedure, reduce downtime and improve the appearance of hair density.
By participating, you can contribute to research that may revolutionize post-procedure care and cosmetic treatments.
Contributing to Future Research
By volunteering in observational studies like ACN-101, you are playing a crucial role in the development of future therapies. The data collected from this study can help the development of new treatments, potentially improving care for future patients. Your participation contributes to important research that can enhance recovery and outcomes for individuals undergoing medical aesthetic procedures.
Study Details
Study Number:
ACN-101
sponsor:
Acorn Biolabs Inc., Toronto, ON
status:
Actively enrolling participants
ClinicalTrials.gov URL
Visit WebsiteHypothesis:
The use of the topical Acorn aHFS reduces the severity and duration of post-procedure symptoms, downtime, and improves aesthetic outcomes compared to other post-procedure treatments.
Study Locations:
Multiple sites across the United States and Canada, with up to 500 participants enrolled across 50 sites.
Study Duration:
Enrollment is expected to take 7 months, with a maximum follow-up of 12 months per participant. The study is expected to be completed within 20 months.
Objective:
The use of the topical Acorn aHFS reduces the severity and duration of post-procedure symptoms, downtime, and improves aesthetic outcomes compared to other post-procedure treatments.
Eligibility
Who Can Join The Study
Inclusion Criteria:
- Male or Female
- Age: 18-60 years
- Planning to undergo a medical aesthetic procedure included in the study (laser resurfacing, microneedling of the face or scalp, treatment of surgical scars)
- Able to provide informed consent
- Willing to comply with study procedures and follow-up visits
Exclusion Criteria:
- Previous participation in the ACN-101 study
- Current use of investigational products
- Significant medical or psychiatric conditions that may interfere with study participation
- Pregnant or breastfeeding women
The research physician will screen participants and select them for participation based on these criteria.
Participate
Participation in the ACN-101 study offers:
- Access to advanced aesthetic treatment protocols
- Contribution to vital research that can improve future aesthetic procedures
- Regular monitoring and follow-up care by experienced clinicians
Compensation:
Participants will receive up to $250.
Faq
Frequently Asked Questions
How will participating impact when I can have my procedure done?
Your procedure must be scheduled about 2 months after you have provided a hair follicle collection since it takes time to make your personalized autologous hair follicle secretome topical product.
Will I be visiting the clinic more than if I didn't participate in the study?
There are two ways of participating in the study. One way is to only answer electronic questionnaires that come to you electronically (on your mobile phone, tablet or computer) The other way is to visit the clinic for additional follow-up visits and also answer electronic questionnaires. You and your doctor will choose which is the best level of participation for you.
What are the risks of participating?
This study only involves information and picture collection. The procedures and use of the cosmetic aHFS cosmetic product are not controlled by the protocol. Therefore, the only risk of participating is loss of confidentiality. However, we will not use your name in the study, and have systems in place that protect information we collect from you and your doctor. If you give the sponsor of the study approval to use your photos, you may be recognized in that manner. Names will never be used in marketing pieces, and you can decline the use of your photos for marketing.
Can I participate if I'm participating in other studies?
Depending on the other study details, it may be possible to participate. Your doctor will be able to answer this question.
Do I receive free procedures or free cosmetic aHFS if I participate?
No, however you will be compensated $10 for each time you answer questionnaires and $50 for clinic visits.
Will this change how my procedure is done?
No, your medical aesthetic procedure will not change due to your participation in the study. It will be competed per your doctor's recommendations and standard procedures.
Can I participate if I am receiving other treatments, for example, minoxidil for hair?
Yes, however there are time frames of stopping use, not altering the dose or not starting new treatments that your doctor will review to make sure you can participate.