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New treatment option for Androgenic Alopecia
Official title Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)
ClinicalTrials.gov ID: NCT07107841
What this study is testing
- What it's testing
- (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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- people 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...
- FEMALE people 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...
- 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
You likely can't join if
- people 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.
See the full eligibility criteria
- people 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 people 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)...
- 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
- people 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...
- people 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
- people unable to communicate with the investigator and staff
- Any health condition that in the investigator's opinion should preclude participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- West Hollywood, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Hollywood, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.