Recruiting
Early Phase 1

Secretome

Sponsor:

Acorn Biolabs Inc.

Code:

NCT07227883

Conditions

Facial Aging

Rejuvenation

Stem Cell

Stem Cell Banking

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Interventions

Autologous Hair Follicle-Derived Secretome

Control Saline

Study Details

Brief summary:

Secretome treatment for facial rejuvenation

Conditions

Facial Aging

Rejuvenation

Stem Cell

Stem Cell Banking

Study ID

NCT07227883

Start date

Dec 15, 2025

Status verified date

Mar, 2026

Completion date

Dec 20, 2026

Anticipated

Primary completion date

Dec 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Accepted

Inclusion Criteria

  • Male or Female
  • Age: ≥30 and ≤ 75 at the time of consent.
  • Fitzpatrick skin types I-V
  • Moderate to very severe facial aging according to the SASSQ for the categories of elasticity, wrinkles, and skin roughness.
  • Willing to refrain from cosmetic procedures throughout the study period (i.e. laser treatments, chemical peels, microneedling, dermal filler injections, neuromodulator injections, etc.)
  • Willing to use study support products as directed and will not introduce any new skin care or makeup products throughout the study period. Subjects will be provided with a Skincare Kit: Cetaphil Gentle Skin Cleanser 20 oz, Cetaphil Daily Hydrating Lotion 3 oz, Cetaphil Sheer Mineral Liquid Face Sunscreen SPF 50 . Two of each will be provided with application instructions.
  • Male subjects with facial hair must be willing to shave the morning of their treatments/follow-up visits.
  • Willing to minimize sun/ultraviolet light exposure for the duration of the study, including all of the following: applying sunscreen daily, at least 15 minutes before going outside; wearing sun-protective clothing (e.g., a hat, sunglasses) when outdoors; reapplying sunscreen every 2 hours during outdoor activities; avoiding tanning bed/tanning product use.
  • Competent and willing to provide written, informed consent to participate in all study activities
  • Willing and able to tolerate multiple injections and attend all study visits
  • Negative urine pregnancy test result at the time of screening (if applicable)
  • For female subjects of childbearing potential, must be willing to use an acceptable form of birth control (oral contraceptives, hormonal implants, intrauterine device \[IUD\], hormonal injectables specifically for birth control, contraceptive patch or ring, tubal ligation \[tubes tied\], or total sexual abstinence) during the entire course of the study. All systemic birth control measures (oral, hormonal implants, injectables) must be in consistent use for at least 30 days prior to study enrollment. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.

Exclusion Criteria

  • Use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide, diclofenac, vitamin C, alpha hydroxy acids, or photodynamic therapy (PDT) to the face within 4 weeks prior to baseline photography and throughout the study period
  • Dermatologic diseases or conditions (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, wounds, infections, irritation, sunburn, windburn, etc.) in the treatment area that could interfere with the study, in the opinion of the Investigator
  • Starting use or stopping use of GLP-1 agonists, or planned weight loss or gain during the study period. Subjects using GLP-1 agonists must be taking the drug for maintenance AND body weight must have been stable for at least 3 months prior to initial study treatment.
  • History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
  • Previous medical aesthetic rejuvenation treatments on the face, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to baseline photography
  • Treatment with neuromodulators in crow's feet, glabellar region, or frontalis muscles within 4 months prior to baseline photography
  • Treatment with dermal fillers, collagen stimulators, fat injections or permanent fillers within the past 6 months prior to baseline photography.
  • Patients using other anti-aging treatments/procedures/systemic medications or injections administered/prescribed by a medical professional before starting the study, if the investigator believes they will confound the results. Consulting with Sponsor is encouraged.
  • Heavy smoker (>1 pack of cigarettes a day)
  • Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area within 6 months prior to baseline photography
  • Currently be taking isotretinoin (Accutane).
  • Subjects on an immunosuppressant or have an autoimmune condition (except stable, controlled Hashimoto's thyroiditis)
  • Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction, etc.) during the 12-month period prior to baseline photography
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
  • Severe active infection (e.g. HIV, HepB or C, UTI, etc.)
  • Current or recent (within last 5 years) malignancy (except basal cell and squamous cell skin cancers as long as basal cell was not on the face)
  • History of systemic chemotherapy or radiation within the last 5 years
  • Continuous/daily use of nonsteroidal anti-inflammatory or Vitamin E, unless discontinued within 7 days before 1st treatment and only used as needed through the trial period.
  • Anticipated pregnancy or trying to become pregnant in the next year
  • Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents such dabigatran, rivaroxaban, apixaban, endoxaban and betrixaban; warfarin/coumarins). Low dose aspirin and omega-3 supplements allowed.
  • Any other criterion that is based on the clinical judgment of the investigator may place the subject at risk or confound study results

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control

Saline will act as a control and will be intradermally injected.

experimental: Active-Secretome

Autologous Hair follicle Derived Secretome

Interventions

Autologous Hair Follicle-Derived Secretome

This interventional product is a secretome derived from the stem cells that reside in the hair follicle.

Control Saline

Saline solution will be the placebo control. The active is diluted with saline so this is an appropriate control.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Baseline to 120days ]
  • VISIA-CR Skin Quality Scores (VISIA-CR is not an acronym, it is a brand name of the system) [ Time Frame: Baseline, 30, 60, 90 and 120 days ]

Central Contacts and Locations

Central contacts

Lisa M Campbell, PhD

905-695-6956lisa.campbell@acorn.me

Heather Dwyer, MSc, CCRP

905-695-6956heather@acorn.me

Locations

Steve Yoelin, MD

Recruiting

Newport Beach, California, United States, 92663

Contacts

Shiraz Rezaei.

srezaei.symd@gmail.com

Steve Yoelin, MD

(949) 548-2711info@steveyoelinmd.com

Principal Investigator:

Steve Yoelin, MD

More Information

Sponsor

Acorn Biolabs Inc.

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • stem cells
  • secretome
  • autologous
  • hair follicle
  • aging
  • facial
  • face
  • under eyes
  • wrinkles
  • anti-aging
  • rejuvenation
  • regeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Acorn Biolabs Inc. on 2026-04-01.