An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin

April 2016 | Volume 15 | Issue 4 | Original Article | 476 | Copyright © April 2016


James H. Herndon Jr. MD,a Lily I. Jiang PhD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb

aThomas J. Stephens and Associates, Richardson, TX
bRevision Skincare, Irving, TX

hyperpigmentation (mottled and discrete), skin tone (color) evenness, tactile smoothness, and visual smoothness compared with baseline scores. After 12 weeks of twice daily use:
  • 79% of subjects showed an improvement in clarity/brightness with an average improvement of 9.4%
  • 100% of subjects showed an improvement in fine lines with an average improvement of 15.5%
  • 72% of subjects showed an improvement in evenness of skin tone (redness) with an average improvement of 10.7%
  • 86% of subjects showed an improvement in firmness with an average improvement of 10.3%
  • 75% of subjects showed an improvement in global hyperpigmentation (mottled) with an average improvement of 9.9%
  • 77% of subjects showed an improvement in global hyperpigmentation (discrete) with an average improvement of 11.0%
  • 90% of subjects showed an improvement in overall photodamage with an average improvement of 10.5%
  • 100% of subjects showed an improvement in radiance with an average improvement of 13.0%
  • 77% of subjects showed an improvement in skin tone (color) evenness with an average improvement of 12.4%
  • 90% of subjects showed an improvement in tactile smoothness with an average improvement of 13.6%
  • 75% of subjects showed an improvement in visual smoothness with an average improvement of 9.3%
  • 86% of subjects showed an improvement in wrinkles with an average improvement of 10.4%
    • table 3

    Tolerability Evaluations

    Use of 0.5% retinol treatment and anti-aging moisturizer with vitamin C resulted in a statistically significant increase (worsening) in clinical grading scores for dryness on the face at weeks 4 (15% of subjects) and 8 (13% of subjects) compared with baseline scores. However, this change did not persist to the week 12 timepoint, and an increase in dryness is expected when introducing a retinol product to a facial skin care regimen. No statistically significant changes from baseline were detected for erythema, scaling, burning, stinging, or itching at weeks 4, 8, and 12.

    Self-Assessment Questionnaires

    A statistically significant proportion of subjects responded favorably to all skin condition inquiries included in the self-assessment questionnaire. In addition, a statistically
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