title: A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation.
abstract: OBJECTIVE
  Many treatment modalities exist to counteract the effects of cutaneous aging. Ablative methods have been the mainstay for nonsurgical facial rejuvenation. In recent years, nonablative techniques have been developed with the aim of achieving facial rejuvenation without epidermal damage. Light-emitting diode (LED) photorejuvenation is a novel nonablative technique that induces collagen synthesis through biophotomodulatory pathways.
  
  
  METHODS
  A single-center, randomized, single-blinded, placebo-controlled, split-faced clinical trial was designed. Thirty-two patients were enrolled for a 12-week study. Patients were randomized into one of four groups: Group A, treatment with KLOX-001 gel formulation and white LED (placebo) light; Group B, treatment with a placebo/base gel (no active chromophore) formulation and KLOX LED light; Group C, treatment with KLOX-001 gel formulation and KLOX LED light; and Group D, treatment with the standard skin rejuvenating treatment (0.1% retinol-based cream). Patients received treatment at weeks 0, 1, 2, and 3, and returned to the clinic at weeks 4, 8, and 12 for clinical assessments performed by an independent, blinded committee of physicians using subjective clinician assessment scales. Tolerability, adverse outcomes, and patient satisfaction were also assessed.
  
  
  RESULTS
  Analysis demonstrated that the KLOX LED light with KLOX placebo/base gel and the KLOX LED light + KLOX-001 gel formulation groups were superior to standard of care and KLOX-001 gel formulation with placebo light on subjective clinical assessment and multiple wrinkle scales, with statistically significant results obtained for brow positioning, perioral wrinkling, and total wrinkle score.
  
  
  CONCLUSIONS
  The study results show that KLOX LED light with KLOX-001 gel formulation and KLOX LED light with KLOX placebo/base gel are effective, safe, well-tolerated, and painless treatment modalities for skin rejuvenation.
authors.affiliation: Victoria Park, Plastic Surgery Section, Westmount, QC, Canada.
authors.forename: Andreas
authors.initials: A
authors.lastname: Nikolis
authors.affiliation: Dermatology Department, University of Montreal Health Centre, Montreal, QC, Canada.
authors.forename: Steven
authors.initials: S
authors.lastname: Bernstein
authors.affiliation: Department of Plastic Surgery, USC School of Medicine, Beverley Hills, CA, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Kinney
authors.affiliation: Department of Plastic and Reconstructive Surgery, La Sapienza, Rome, Italy.
authors.forename: Nicolo
authors.initials: N
authors.lastname: Scuderi
authors.affiliation: KLOX Technologies, Laval, Canada.
authors.forename: Shipra
authors.initials: S
authors.lastname: Rastogi
authors.affiliation: JSS Medical Research, Montreal, QC, Canada.
authors.forename: John S
authors.initials: JS
authors.lastname: Sampalis
keywords: biophotonics; chromophore; non-invasive; rejuvenation; skin rejuvenation