NCT07227883

Secretome Treatment for Facial Rejuvenation

Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for Facial Rejuvenation

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Acorn Biolabs Inc. · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Secretome treatment for facial rejuvenation

Detailed description

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.

Conditions

• Facial Aging
• Rejuvenation
• Stem Cell
• Stem Cell Banking

Interventions

Type	Name	Description
OTHER	Autologous Hair Follicle-Derived Secretome	This interventional product is a secretome derived from the stem cells that reside in the hair follicle.
OTHER	Control Saline	Saline solution will be the placebo control. The active is diluted with saline so this is an appropriate control.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-20
• Completion: 2026-12-20
• First posted: 2025-11-13
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States