ClinicalTrials.gg
RecruitingNCT07227883Updated Jul 6, 2026

Secretome Treatment for Facial Rejuvenation

An Early Phase 1 interventional study of Autologous Hair Follicle-Derived Secretome and Control Saline in Facial Aging, Rejuvenation and Stem Cell, sponsored by Acorn Biolabs Inc.. Recruiting at 1 site in United States. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Acorn Biolabs Inc. · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

Secretome treatment for facial rejuvenation

Read the detailed description

This study will quantitatively evaluate the efficacy and safety of the autologous hair follicle secretome for skin rejuvenation. The secretome is produced by non-invasively collecting hair follicles by plucking 50-75 hairs. Ten follicles are selected to cultured in media (proprietary xeno- and human protein free) for 4 weeks and conditioned media is collected and lyophilized to produce the autologous secretome product. The secretome contains growth factors, extracellular matrix molecules, cytokines, exosomes, etc. Upon use, the autologous secretome is diluted in saline and used on the subject the hairs were collected from. This study is evaluating the efficacy and safety of intradermal injections of the secretome for facial rejuvenation. The study is a double-blind and open label extension phases, randomized, placebo-controlled trial. Double-blind up to 120 days, followed by an open label extension for control patients opting to cross-over and receive active treatment.

The active treatment consists of two vials of secretome. Each vial of secretome diluted with 2ml of bacteriostatic saline (0.9% benzyl alcohol). A total of 1ml (0.5ml per side) of secretome will be injected using a canula under the eyes. In addition, a total of 2ml (1ml per side) of secretome will be injected intradermally on each side of the face. The face injections include 20 injection points per side, 1cm apart, placed in a grid-like from the temple down, including the cheek, nasal labial fold and marionette lines. A needle called MicronJet 800 will be used to ensure face injections are intradermal, not subcutaneous.

The control treatment (bacteriostatic saline) will be delivered following the same schema.

02

Conditions studied

  • Facial Aging
  • Rejuvenation
  • Stem Cell
  • Stem Cell Banking

Keywords

  • stem cells
  • secretome
  • autologous
  • hair follicle
  • aging
  • facial
  • face
  • under eyes
  • wrinkles
  • anti-aging
  • rejuvenation
  • regeneration
03

In context

Lead sponsor

Acorn Biolabs Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or Female
  2. Age: ≥30 and ≤ 75 at the time of consent.
  3. Fitzpatrick skin types I-V
  4. Moderate to very severe facial aging according to the SASSQ for the categories of elasticity, wrinkles, and skin roughness.
  5. Willing to refrain from cosmetic procedures throughout the study period (i.e. laser treatments, chemical peels, microneedling, dermal filler injections, neuromodulator injections below the mid-eye level [forehead and region between the brows is allowed]).
  6. 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.
  7. Male subjects with facial hair must be willing to shave the morning of their treatments/follow-up visits.
  8. 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.
  9. Competent and willing to provide written, to participate in all study activities
  10. Willing and able to tolerate multiple injections and attend all study visits
  11. Negative urine pregnancy test result at the time of screening (if applicable)
  12. For female subjects of , must be willing to use an acceptable form of 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 , without a uterus and/or both ovaries, or has had a bilateral tubal ligation.

Exclusion criteria

Exclusion Criteria

  1. 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
  2. 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
  3. Starting to use or stopping the 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.
  4. History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
  5. 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
  6. Treatment with neuromodulators in crow's feet or below mid-eye level within 4 months prior to baseline photography
  7. Treatment with dermal fillers, collagen stimulators, fat injections or permanent fillers within the past 6 months prior to baseline photography.
  8. 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.
  9. Heavy smoker (>1 pack of cigarettes a day)
  10. 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
  11. Currently be taking isotretinoin (Accutane).
  12. Subjects on an or have an condition (except stable, controlled Hashimoto's thyroiditis)
  13. Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction, etc.) during the 12-month period prior to baseline photography
  14. Current participation or participation within 30 days prior to the start of this study in a drug or other research study
  15. Severe active infection (e.g. , HepB or C, UTI, etc.)
  16. Current or recent (within last 5 years) (except basal cell and squamous cell skin cancers as long as basal cell was not on the face)
  17. History of systemic chemotherapy or radiation within the last 5 years
  18. 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.
  19. Anticipated pregnancy or trying to become pregnant in the next year
  20. 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.
  21. Any other criterion based on the clinical judgment of the investigator may place the subject at risk or confound study results
  22. Unable or unwilling to comply with the requirements (i.e. removal of jewelry, makeup, facial hair) of the study protocol in the opinion of the Investigator.
  23. Subject has any disorder that may prevent compliance, such as a history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the evaluator's opinion, interfere with the study.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Placebo comparator
    Control

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

    Other: Control Saline

  • Experimental
    Active-Secretome

    Autologous Hair follicle Derived Secretome

    Other: Autologous Hair Follicle-Derived Secretome

Interventions

  • OtherAutologous Hair Follicle-Derived Secretome

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

    Also known as: aHFS, Hair Follicle Secretome, Hair Follicle Stem Cell

  • OtherControl Saline

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

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Adverse events and expected treatment effects will be collected at each time point. Spontaneously reported adverse events will also be collected.

    Time frame: Baseline to 120days

  2. VISIA-CR Skin Quality Scores (VISIA-CR is not an acronym, it is a brand name of the system)

    VISIA-CR photography and analysis of skin quality (redness, wrinkles, UV spots, skin roughness). Scores range from 0-100. Lower scores are improvement.

    Time frame: Baseline, 30, 60, 90 and 120 days

Secondary outcomes

  1. Subject Satisfaction

    Subject Satisfaction Scale is a 5-point Likert Scale. The scale is Dissatisfied, Neither Satisfied or Dissatisfied, Slightly Satisfied, Satisfied and Very Satisfied.

    Time frame: 30, 60, 90 and 120 days

07

Study locations

1 of 1 sites recruiting
  • Steve Yoelin, MD
    Newport Beach, California 92663, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2025
First posted
Nov 13, 2025
StartActual
Dec 15, 2025
Primary completionEst.
Dec 20, 2026
CompletionEst.
Dec 20, 2026
Last update
Jul 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07227883
Lead sponsor
Acorn Biolabs Inc.
Responsible party
Sponsor
First posted
Nov 13, 2025
Start date
Dec 15, 2025
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Jul 6, 2026

Study contacts

Lisa M Campbell, PhD
Contact
lisa.campbell@acorn.me
905-695-6956
Heather Dwyer, MSc, CCRP
Contact
heather@acorn.me
905-695-6956

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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