Secretome Treatment for Facial Rejuvenation

NCT07227883 | Recruiting Early Phase 1

• 1 other identifier: ACN-301
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Secretome treatment for facial rejuvenation

Conditions

Rejuvenation; Facial Aging; Stem Cell; Stem Cell Banking

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 30, 60, 90 and 120 days

Secondary Outcomes (1)

• Subject Satisfaction

  30, 60, 90 and 120 days

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Control Saline

Active-Secretome

EXPERIMENTAL

Autologous Hair follicle Derived Secretome

Other: Autologous Hair Follicle-Derived Secretome

Interventions

Control Saline OTHER

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

Control

Autologous Hair Follicle-Derived Secretome OTHER

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

Active-Secretome

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Acorn Biolabs Inc.: lead

Study Sites (1)

Steve Yoelin, MD

Newport Beach, California, 92663, United States

RECRUITING

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa M Campbell, PhD

CONTACT

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

Heather Dwyer, MSc, CCRP

CONTACT

905-695-6956; heather@acorn.me

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor, except for clinical study managers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Optional cross-over after blinded phase of study

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 13, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)