Androgenic AlopeciaNCT07107841
Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)
A study testing Autologous Hair Follicle-Derived Secretome in people with Androgenic Alopecia and Alopecia, run by Acorn Biolabs Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia, Alopecia, Baldness
- What is being tested?
- Autologous Hair Follicle-Derived Secretome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 15 Sep 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Heather Dwyer contact
United States1 site, 1 recruiting
- Recruiting
Ziering Medical
West Hollywood, California, 90069
Craig Ziering, MD, 310-360-8860, charmane@zieringhair.com
About this study
Official title: Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for the Treatment of Androgenic Alopecia (Single Site)
(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.
Read the detailed description
(SINGLE SITE Study) Androgenic alopecia is a common condition causing hair loss and baldness in both men and women. Approximately 80 million men and women are affected by the condition in the US alone. Although there are a number of products on the market, both over the counter and prescribed, used for androgenic alopecia, they are only somewhat effective to slow the progression.
This trial will evaluate a new approach involving the injection of an autologous product made from the cellular secretions of hair follicles (secretome). Proteonomic analysis has demonstrated that this secretome contains anywhere from 2-22 times the bioactive components of platelet rich plasma (PRP) when compared within the same individual. The hypothesis is that repeat injections of autologous hair follicle-derived secretome will safely and effectively stimulate hair regrowth in men and women suffering from androgenic alopecia.
The trial is a double-blind, randomized, placebo controlled study in 60 patients who are on a stable (>6 months) regimen of minoxidil and 5 alfa-reductase inhibitors. The injections will be delivered at baseline (day 0), 30, 90, 180, 270 and 365 days as follows:
- Each vial of secretome will be diluted with 2ml of saline
- Each quadrant of the affected scalp will receive one vial of secretome
- Injections will be delivered in a grid-like pattern with injections spaced ~1cm apart
- Approximately 20 injections (0.1ml/injection) will be delivered to each alopecia affected quadrant
- Conditions
- Androgenic Alopecia, Alopecia, Baldness
- Being tested
- Autologous Hair Follicle-Derived Secretome, Placebo Control
- Keywords
- secretome, alopecia, Hair, stem cells, androgenic, androgenetic, Hormone, scalp, hair loss, baldness, bald, hair follicle, Acorn
- Medical subject headings
- Alopecia
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 follicles are plucked, cultured and the product is the resulting cell secretions (secretome) collected from the conditioned media.
Placebo ControlOther
The same saline used for diluting the active treatment in will be used as a control.
| Study group | Role | What they receive |
|---|---|---|
| Active-Secretome | Active comparator | Intervention is autologous hair follicle-derived secretome diluted in saline Receives: Other: Autologous Hair Follicle-Derived Secretome |
| Placebo Control | Placebo comparator | Placebo control is saline. Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Area Hair Counts (TAHC)
Non-vellus TAHC is the number of non-vellus (terminal) hairs within 1 cm² scalp
Measured: 180 Days after Baseline
Safety
Incidence rates of treatment-related adverse events compared between the active and placebo arm
Measured: 180 days from Baseline
Secondary outcomes (4)
Mean Total Hair Density (vellus and non-vellus/terminal)
Mean Total Hair Density (vellus and non-vellus/terminal): measured by Trichoscan device
Measured: 30, 90, 270 and 365 days
Patient Satisfaction
Patient satisfaction collected using a 5 point Likert scale
Measured: 30, 90, 270 and 365 days
Hair thickness improvement
Hair thickness improvement measured by Trichoscan device
Measured: 30, 90, 180, 270 and 365 days
Patient Global Impression of Change (PGIC)
Patient rated improvement in alopecia based on comparison of Baseline to follow-up time point
Measured: 180 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start16 Oct 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo controlled, double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acorn Biolabs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa M Campbell, PhD, Study director, Acorn Biolabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107841
- Sponsor's protocol ID
- ACN-401
- Status last verified
- Feb 2026
- First submitted
- 31 Jul 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a proof of concept study on a unique product unlike others so there is no reason to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 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 the Treatment of Androgenic Alopecia (Single Site)
- ClinicalTrials.gov ID
- NCT07107841
- Acronym / sponsor ID
- ACN-401
- Conditions
- Androgenic Alopecia, Alopecia, Baldness
- Keywords
- secretome, alopecia, Hair, stem cells, androgenic, androgenetic, Hormone, scalp
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Acorn Biolabs Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 6 Aug 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.
(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.
Detailed description
(SINGLE SITE Study) Androgenic alopecia is a common condition causing hair loss and baldness in both men and women. Approximately 80 million men and women are affected by the condition in the US alone. Although there are a number of products on the market, both over the counter and prescribed, used for androgenic alopecia, they are only somewhat effective to slow the progression.
This trial will evaluate a new approach involving the injection of an autologous product made from the cellular secretions of hair follicles (secretome). Proteonomic analysis has demonstrated that this secretome contains anywhere from 2-22 times the bioactive components of platelet rich plasma (PRP) when compared within the same individual. The hypothesis is that repeat injections of autologous hair follicle-derived secretome will safely and effectively stimulate hair regrowth in men and women suffering from androgenic alopecia.
The trial is a double-blind, randomized, placebo controlled study in 60 patients who are on a stable (>6 months) regimen of minoxidil and 5 alfa-reductase inhibitors. The injections will be delivered at baseline (day 0), 30, 90, 180, 270 and 365 days as follows:
- Each vial of secretome will be diluted with 2ml of saline
- Each quadrant of the affected scalp will receive one vial of secretome
- Injections will be delivered in a grid-like pattern with injections spaced ~1cm apart
- Approximately 20 injections (0.1ml/injection) will be delivered to each alopecia affected quadrant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Active-Secretome | Active comparator | Other: Autologous Hair Follicle-Derived SecretomeIntervention is autologous hair follicle-derived secretome diluted in saline |
| Placebo Control | Placebo comparator | Other: Placebo ControlPlacebo control is saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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: aHFSHair follicles are plucked, cultured and the product is the resulting cell secretions (secretome) collected from the conditioned media. | Other | Active-Secretome |
| Placebo ControlThe same saline used for diluting the active treatment in will be used as a control. | Other | Placebo Control |
Primary outcome
Target Area Hair Counts (TAHC)
Time frame: 180 Days after Baseline
Non-vellus TAHC is the number of non-vellus (terminal) hairs within 1 cm² scalp
Safety
Time frame: 180 days from Baseline
Incidence rates of treatment-related adverse events compared between the active and placebo arm
4 secondary outcomes
Mean Total Hair Density (vellus and non-vellus/terminal)
Time frame: 30, 90, 270 and 365 days
Patient Satisfaction
Time frame: 30, 90, 270 and 365 days
Hair thickness improvement
Time frame: 30, 90, 180, 270 and 365 days
Patient Global Impression of Change (PGIC)
Time frame: 180 and 365 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 12 Feb 2026.
- Individual participant dataSharing planned: No. This is a proof of concept study on a unique product unlike others so there is no reason to share IPD
Related trials for Androgenic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
Heather Dwyer contact
Lisa M Campbell, PhD study director
Acorn Biolabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Hair Follicle-Derived Secretome in people with Androgenic Alopecia and Alopecia, 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 17 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 12 Feb 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.
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@acorn.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Area Hair Counts (TAHC) (time frame: 180 Days after Baseline). 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 12 Feb 2026.