Recruiting

Secretome

Sponsor:

Acorn Biolabs Inc.

Code:

NCT07107841

Conditions

Androgenic Alopecia

Alopecia

Baldness

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Autologous Hair Follicle-Derived Secretome

Placebo Control

Study Details

Brief summary:

(SINGLE SITE Study) The purpose of this clinical trial is to evaluate the safety and efficacy of the use of an autologous hair follicle derived secretome for androgenous alopecia. The secretome will be injected into the scalp at baseline, and days 30, 90, 180, 270 and 365.

Hair growth will be quantitatively measured for density and thickness. PROs will also be collected from participants. This study will be run at a SINGLE SITE.

Conditions

Androgenic Alopecia

Alopecia

Baldness

Study ID

NCT07107841

Start date

Oct 16, 2025

Status verified date

Feb, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria

  • SUBJECTS MUST BE ON A STABLE COURSE OF MINOXIDIL (ORAL OR TOPICAL) AND/OR 5-ALPHA REDUCTASE INHIBITORS. THEY MUST HAVE BEEN ON THE SAME 5-ALPHA REDUCTASE INHIBITOR FOR ≥12 MONTHS PRIOR TO BASELINE.
  • FEMALE SUBJECTS MUST NOT BE ON HAIR GROWTH MEDICATIONS OR TOPICALS FOR ≥6 MONTHS PRIOR TO BASELINE.
  • TESTOSTERONE REPLACEMENT THERAPY (TRT) IN ANY FORM (E.G. DEPO-, INJECTABLE, TOPICAL, PATCHES, NASAL GEL, ORAL, PELLET ETC.) IS ALLOWED AS LONG AS SUBJECT HAS BEEN ON A STABLE COURSE (IN THE OPINION OF THE INVESTIGATOR) OF TRT FOR ≥12 MONTHS.
  • Biological sex: Male and Female (up to n=20 males and up to n=10 females will be in each arm for a total of up to n=40 males and up to n=20 females)
  • Age: ≥18 - 65 years
  • Subjects with Androgenic alopecia
  • No intention to start new hair growth medications and no intention to change the dosage or usage of minoxidil or 5-alpha reductase inhibitors until the end of their participation in the trial.
  • Competent and willing to provide written, informed consent to participate in all study activities.
  • Willing and able to tolerate multiple injections of the study product.
  • Must be able to attend all study related clinical visits.
  • Willing to maintain the same hair style as at the Screening Visit for the duration of the study.
  • Must be willing to have small (diameter similar to a pencil lead) UV (invisible) or red colored tattoo dots applied to scalp (up to 5) and touch up tattoos if necessary. UV tattoo dots only show under black light. Subjects will chose UV or red.

Exclusion Criteria

  • Subjects with clinical diagnosis of alopecia areata or other non-androgenic forms of alopecia.
  • Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
  • Scalp infection
  • Severe active systemic infection
  • Cuts or abrasions on the scalp
  • History of surgical hair restoration in the last 12 months.
  • Current or recent (within last 5 years) malignancy (except basal cell and squamous cell skin cancers)
  • History of systemic chemotherapy or radiation
  • History of thyroid dysfunction
  • History of autoimmune disorder (specifically Graves disease, Hashimoto thyroiditis, or systemic lupus erythematosus)
  • 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.
  • Use of any medications that potentially cause drug-induced hair loss (e.g., depo-testosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within the last 3 months.
  • Known allergy or sensitivity to tattoo ink.
  • Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents such dabigatran, rivaroxaban, apixaban, edoxaban and betrixaban; warfarin/coumarins)
  • Significant tendency to develop keloids or hypertrophic scarring
  • Subjects unable to communicate with the investigator and staff
  • Any health condition that in the investigator's opinion should preclude participation in this study

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active-Secretome

Intervention is autologous hair follicle-derived secretome diluted in saline

placebo comparator: Placebo Control

Placebo control is saline.

Interventions

Autologous Hair Follicle-Derived Secretome

Hair follicles are plucked, cultured and the product is the resulting cell secretions (secretome) collected from the conditioned media.

Placebo Control

The same saline used for diluting the active treatment in will be used as a control.

Primary outcome measure

  • Target Area Hair Counts (TAHC) [ Time Frame: 180 Days after Baseline ]
  • Safety [ Time Frame: 180 days from Baseline ]

Central Contacts and Locations

Central contacts

Lisa M Campbell, PhD

905-695-6956lisa@acorn.me

Heather Dwyer

heather@acorn.me

Locations

Ziering Medical

Recruiting

West Hollywood, California, United States, 90069

Contacts

Craig Ziering, MD

310-360-8860charmane@zieringhair.com

More Information

Sponsor

Acorn Biolabs Inc.

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • secretome
  • alopecia
  • Hair
  • stem cells
  • androgenic
  • androgenetic
  • Hormone
  • scalp
  • hair loss
  • baldness
  • bald
  • hair follicle
  • Acorn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Acorn Biolabs Inc. on 2026-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.