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
Andreas Nikolis,1 Steven Bernstein,2 Brian Kinney,3 Nicolo Scuderi,4 Shipra Rastogi,5 John S Sampalis6 1Victoria Park, Plastic Surgery Section, Westmount, QC, Canada; 2Dermatology Department, University of Montreal Health Centre, Montreal, QC, Canada; 3Department of Plastic Surgery, USC Sch...
Main Authors: | , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Dove Medical Press
2016-05-01
|
Series: | Clinical, Cosmetic and Investigational Dermatology |
Subjects: | |
Online Access: | https://www.dovepress.com/a-randomized-placebo-controlled-single-blinded-split-faced-clinical-tr-peer-reviewed-article-CCID |
id |
doaj-b4c9e52ba6b9474096011df4b095775c |
---|---|
record_format |
Article |
spelling |
doaj-b4c9e52ba6b9474096011df4b095775c2020-11-24T22:34:55ZengDove Medical PressClinical, Cosmetic and Investigational Dermatology1178-70152016-05-012016Issue 111512526919A 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 rejuvenationNikolis ABernstein SKinney BScuderi NRastogi SSampalis JSAndreas Nikolis,1 Steven Bernstein,2 Brian Kinney,3 Nicolo Scuderi,4 Shipra Rastogi,5 John S Sampalis6 1Victoria Park, Plastic Surgery Section, Westmount, QC, Canada; 2Dermatology Department, University of Montreal Health Centre, Montreal, QC, Canada; 3Department of Plastic Surgery, USC School of Medicine, Beverley Hills, CA, USA; 4Department of Plastic and Reconstructive Surgery, La Sapienza, Rome, Italy; 5KLOX Technologies, Laval, 6JSS Medical Research, Montreal, QC, Canada Purpose: 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. Materials and 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. Conclusion: 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. Keywords: biophotonics, skin rejuvenation, chromophore, rejuvenation, non-invasivehttps://www.dovepress.com/a-randomized-placebo-controlled-single-blinded-split-faced-clinical-tr-peer-reviewed-article-CCIDBiophotonicsSkin rejuvenationChromophoreLED light |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nikolis A Bernstein S Kinney B Scuderi N Rastogi S Sampalis JS |
spellingShingle |
Nikolis A Bernstein S Kinney B Scuderi N Rastogi S Sampalis JS 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 Clinical, Cosmetic and Investigational Dermatology Biophotonics Skin rejuvenation Chromophore LED light |
author_facet |
Nikolis A Bernstein S Kinney B Scuderi N Rastogi S Sampalis JS |
author_sort |
Nikolis A |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Dove Medical Press |
series |
Clinical, Cosmetic and Investigational Dermatology |
issn |
1178-7015 |
publishDate |
2016-05-01 |
description |
Andreas Nikolis,1 Steven Bernstein,2 Brian Kinney,3 Nicolo Scuderi,4 Shipra Rastogi,5 John S Sampalis6 1Victoria Park, Plastic Surgery Section, Westmount, QC, Canada; 2Dermatology Department, University of Montreal Health Centre, Montreal, QC, Canada; 3Department of Plastic Surgery, USC School of Medicine, Beverley Hills, CA, USA; 4Department of Plastic and Reconstructive Surgery, La Sapienza, Rome, Italy; 5KLOX Technologies, Laval, 6JSS Medical Research, Montreal, QC, Canada Purpose: 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. Materials and 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. Conclusion: 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. Keywords: biophotonics, skin rejuvenation, chromophore, rejuvenation, non-invasive |
topic |
Biophotonics Skin rejuvenation Chromophore LED light |
url |
https://www.dovepress.com/a-randomized-placebo-controlled-single-blinded-split-faced-clinical-tr-peer-reviewed-article-CCID |
work_keys_str_mv |
AT nikolisa arandomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT bernsteins arandomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT kinneyb arandomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT scuderin arandomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT rastogis arandomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT sampalisjs arandomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT nikolisa randomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT bernsteins randomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT kinneyb randomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT scuderin randomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT rastogis randomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation AT sampalisjs randomizedplacebocontrolledsingleblindedsplitfacedclinicaltrialevaluatingtheefficacyandsafetyofklox001gelformulationwithkloxlightemittingdiodelightonfacialrejuvenation |
_version_ |
1725725710083948544 |