Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

NCT07107841 | Recruiting DMC

• 1 other identifier: ACN-401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Target Area Hair Counts (TAHC)

  Non-vellus TAHC is the number of non-vellus (terminal) hairs within 1 cm² scalp

  180 Days after Baseline

• Safety

  Incidence rates of treatment-related adverse events compared between the active and placebo arm

  180 days from Baseline

Secondary Outcomes (4)

• Mean Total Hair Density (vellus and non-vellus/terminal)

  30, 90, 270 and 365 days

• Patient Satisfaction

  30, 90, 270 and 365 days

• Hair thickness improvement

  30, 90, 180, 270 and 365 days

• Patient Global Impression of Change (PGIC)

  180 and 365 days

Study Arms (2)

Active-Secretome

ACTIVE COMPARATOR

Intervention is autologous hair follicle-derived secretome diluted in saline

Other: Autologous Hair Follicle-Derived Secretome

Placebo Control

PLACEBO COMPARATOR

Placebo control is saline.

Other: Placebo Control

Interventions

Autologous Hair Follicle-Derived Secretome OTHER

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

Also known as: aHFS

Active-Secretome

Placebo Control OTHER

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

Placebo Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorn Biolabs Inc.: lead

Study Sites (1)

Ziering Medical

West Hollywood, California, 90069, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa M Campbell, PhD

  Acorn Biolabs

  STUDY DIRECTOR

Central Study Contacts

Lisa M Campbell, PhD

CONTACT

905-695-6956; lisa@acorn.me

Heather Dwyer

CONTACT

heather@acorn.me

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo controlled, double-blind

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 6, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)