An Early Phase 1 interventional study of Autologous Hair Follicle-Derived Secretome and Control Saline in Facial Aging, Rejuvenation and Stem Cell, sponsored by Acorn Biolabs Inc.. Recruiting at 1 site in United States. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Acorn Biolabs Inc. · Early Phase 1, Interventional, and Treatment
Secretome treatment for facial rejuvenation
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.
Acorn Biolabs Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Saline will act as a control and will be intradermally injected.
Other: Control Saline
Autologous Hair follicle Derived Secretome
Other: Autologous Hair Follicle-Derived Secretome
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
Saline solution will be the placebo control. The active is diluted with saline so this is an appropriate control.
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.
Time frame: 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.
Time frame: Baseline, 30, 60, 90 and 120 days
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.
Time frame: 30, 60, 90 and 120 days
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
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Facies
Acorn Biolabs Inc.