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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
This interventional product is a secretome derived from the stem cells that reside in the hair follicle.
Saline solution will be the placebo control. The active is diluted with saline so this is an appropriate control.
Steve Yoelin, MD
Newport Beach, California, United States
RECRUITINGIncidence 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
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