Facial AgingEarly Phase 1NCT07227883
Secretome Treatment for Facial Rejuvenation
A Early Phase 1 study testing Autologous Hair Follicle-Derived Secretome in people with Facial Aging and Rejuvenation, run by Acorn Biolabs Inc. at 1 site in United States.
Trial summary
Secretome treatment for facial rejuvenation Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Aging, Rejuvenation, Stem Cell
- What is being tested?
- Autologous Hair Follicle-Derived Secretome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 20 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 below the mid-eye level [forehead and region between the brows is allowed]).
- 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.
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- 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 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.
Who cannot join
- 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 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.
- 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 or below mid-eye level within 4 months prior to baseline photography
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- 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 based on the clinical judgment of the investigator may place the subject at risk or confound study results
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Steve Yoelin, MD
Newport Beach, California, 92663
Shiraz Rezaei, 949-548-2711, srezaei.symd@gmail.com
Steve Yoelin, MD, (949) 548-2711, info@steveyoelinmd.com
About this study
Official title: Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for Facial Rejuvenation
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.
- Conditions
- Facial Aging, Rejuvenation, Stem Cell, Stem Cell Banking
- Being tested
- Autologous Hair Follicle-Derived Secretome, Control Saline
- Keywords
- stem cells, secretome, autologous, hair follicle, aging, facial, face, under eyes, wrinkles, anti-aging, rejuvenation, regeneration
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Hair Follicle-Derived SecretomeOther
Also called aHFS, Hair Follicle Secretome, Hair Follicle Stem Cell
This interventional product is a secretome derived from the stem cells that reside in the hair follicle.
Control SalineOther
Saline solution will be the placebo control. The active is diluted with saline so this is an appropriate control.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Saline will act as a control and will be intradermally injected. Receives: Other: Control Saline |
| Active-Secretome | Experimental | Autologous Hair follicle Derived Secretome Receives: Other: Autologous Hair Follicle-Derived Secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 120days
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.
Measured: 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.
Measured: 30, 60, 90 and 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start15 Dec 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Optional cross-over after blinded phase of study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acorn Biolabs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227883
- Sponsor's protocol ID
- ACN-301
- Status last verified
- Jul 2026
- First submitted
- 10 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT07227883
- Acronym / sponsor ID
- ACN-301
- Conditions
- Facial Aging, Rejuvenation, Stem Cell, Stem Cell Banking
- Keywords
- stem cells, secretome, autologous, hair follicle, aging, facial, face, under eyes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Acorn Biolabs Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Secretome treatment for facial rejuvenation
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Optional cross-over after blinded phase of study
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control SalineSaline will act as a control and will be intradermally injected. |
| Active-Secretome | Experimental | Other: Autologous Hair Follicle-Derived SecretomeAutologous Hair follicle Derived Secretome |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 below the mid-eye level [forehead and region between the brows is allowed]).
Key exclusion criteria (23 listed)
- 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 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Hair Follicle-Derived SecretomeAlso: aHFS, Hair Follicle Secretome, Hair Follicle Stem CellThis interventional product is a secretome derived from the stem cells that reside in the hair follicle. | Other | Active-Secretome |
| Control SalineSaline solution will be the placebo control. The active is diluted with saline so this is an appropriate control. | Other | Control |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 120days
Adverse events and expected treatment effects will be collected at each time point. Spontaneously reported adverse events will also be collected.
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
VISIA-CR photography and analysis of skin quality (redness, wrinkles, UV spots, skin roughness). Scores range from 0-100. Lower scores are improvement.
1 secondary outcome
Subject Satisfaction
Time frame: 30, 60, 90 and 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous Hair Follicle-Derived Secretome in people with Facial Aging and Rejuvenation, run by Acorn Biolabs Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Campbell, PhD (905-695-6956, lisa.campbell@acorn.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Baseline to 120days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.