Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for the Treatment of Androgenic Alopecia (Single Site)
Acorn Biolabs Inc.
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.
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 cont…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- OtherAutologous Hair Follicle-Derived Secretome
Hair follicles are plucked, cultured and the product is the resulting cell secretions (secretome) collected from the conditioned media.
- OtherPlacebo Control
The same saline used for diluting the active treatment in will be used as a control.
Location
- Ziering MedicalWest Hollywood, California