Patient Experience | What to Expect

Improvement Of Fine Facial Wrinkles And Hyperpigmentation

  • In a clinical trial, 71% of women saw improvement in their fine facial wrinkles, and 83% saw improvement in hyperpigmentation. See clinical trial below.
  • Continued improvement occurred over the 6-month study period.

Tolerability

  • Most patients tolerate tretinoin, the active ingredient in ReFissa, quite well. However, as with any retinoid, there may be some initial side effects, such as flaking, irritation or redness. You may suggest using the product every other night until the skin adjusts, usually within a month.
  • Remind patients to practice sun protection and use sunscreen with SPF 15 or higher during the day.

Clinical Trial Data

The ReFissa bioequivalence 6-month study of 382 patients revealed ReFissa and Renova® 0.05% products are bioequivalent.1 In effect, ReFissa and Renova 0.05% demonstrated no statistical difference from one another, neither product being superior to the other, but both proved superior to placebo. Renova is a registered trademark of Ortho Dermatologics, a division of Ortho-McNeil Pharmaceuticals, Inc.

ReFissa Results:

Fine Facial Wrinkles Measurable Improvement 71%
No Measurable Improvement 29%

Mottled Hyperpigmentation Measurable Improvement 83%
No Measurable Improvement 17%

Fine facial wrinkles and hyperpigmentation were scored at baseline and at Week 24 by the investigator using a 10-point scale on which 0 represents no damage, 2-3=mild, 4-5=moderate, 6-7=moderate/severe and 8-9=severe. The change was calculated as baseline minus the Week 24 evaluations.2 This product was studied with all patients using daily sunscreen and sun avoidance.

1. Please note: The clinical data in the package insert are from Ortho Pharmaceuticals original clinical trials for Renova 0.05% as required for FDA approval. Please see full Prescribing Information and patient package insert. ReFissa is a trademark of trademark of ZO® Skin Health, Inc. © 2017 ZO® Skin Health, Inc. All rights reserved.
2. Data on file, ZO® Skin Health, Inc.