title: 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.
abstract: A 12-week open-label, single-center clinical usage trial was conducted to determine the effectiveness of a dual product regimen consisting of a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in women with mild to moderate hyperpigmented and photodamaged facial skin. Clinical grading of several efficacy parameters, tolerability evaluations, subject self-assessment questionnaires, and digital photography were completed at baseline and at weeks 4, 8, and 12. A total of 44 women completed the study. Effective ingredients incorporated into the 0.5% retinol treatment included encapsulated retinol for a retinol concentration of 0.5%, bakuchiol, and Ophiopogon japonicus root extract. The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form of tetrahexyldecyl ascorbate (THD ascorbate), alpha-tocopheryl acetate (vitamin E) and ubiquinone (coenzyme Q10). The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were improved at week 4. The test regimen was well-perceived by the subjects for various inquiries regarding facial skin condition, product efficacy, and product attributes. Several tolerability parameters were assessed with no statistically significant increase except for dryness. A statistically significant increase in clinical grading scores for dryness on the face occurred at weeks 4 and 8 when compared to baseline scores. The increase in dryness is expected when introducing a retinol product to a facial regimen and the dryness did not persist to the week 12 time point.
authors.forename: James H
authors.initials: JH
authors.lastname: Herndon
authors.forename: Lily I
authors.initials: LI
authors.lastname: Jiang
authors.forename: Tatiana
authors.initials: T
authors.lastname: Kononov
authors.forename: Theresa
authors.initials: T
authors.lastname: Fox
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001205:Ascorbic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D004339:Drug Compounding; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D017495:Hyperpigmentation / Q000175:diagnosis* / Q000188:drug therapy*; D008875:Middle Aged; D011537:Pruritus / Q000139:chemically induced; D015595:Skin Aging / Q000187:drug effects* / Q000473:pathology; D017592:Skin Care / Q000379:methods*; D016896:Treatment Outcome; D014801:Vitamin A / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry
chemical_list: D014801:Vitamin A; D001205:Ascorbic Acid