title: Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region.
abstract: BACKGROUND
  This multicenter, open-label pilot study evaluated safety, efficacy and tolerability of a topical formulation containing a multipotent growth factor resignaling complex (MRCx), when applied to infraorbital and lateral canthal skin.
  
  
  METHODS
  Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales.
  
  
  RESULTS
  Subjects' self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved.
  
  
  CONCLUSIONS
  This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.
authors.forename: Hema
authors.initials: H
authors.lastname: Sundaram
authors.forename: Michael
authors.initials: M
authors.lastname: Gold
authors.forename: Heidi
authors.initials: H
authors.lastname: Waldorf
authors.forename: Mary
authors.initials: M
authors.lastname: Lupo
authors.forename: Vivien L
authors.initials: VL
authors.lastname: Nguyen
authors.forename: Jwala
authors.initials: J
authors.lastname: Karnik
mesh_terms: D000287:Administration, Topical; D000368:Aged; D005260:Female; D006801:Humans; D036341:Intercellular Signaling Peptides and Proteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D008875:Middle Aged; D009915:Orbit; D017060:Patient Satisfaction; D010865:Pilot Projects; D012060:Rejuvenation; D012867:Skin / Q000187:drug effects*; D015595:Skin Aging / Q000187:drug effects*; D012880:Skin Pigmentation; D016896:Treatment Outcome
chemical_list: D036341:Intercellular Signaling Peptides and Proteins