Histological effects of tazarotene 0.1% cream vs. vehicle on photodamaged skin: a 6-month, multicentre, double-blind, randomized, vehicle-controlled study in patients with photodamaged facial skin

Br J Dermatol. 2004 Dec;151(6):1245-52. doi: 10.1111/j.1365-2133.2004.06186.x.

Abstract

Background: Topical tazarotene has been shown to offer efficacy in ameliorating multiple effects of photodamage.

Objectives: To evaluate the histological effects of tazarotene cream on photodamaged skin.

Methods: In this multicentre, double-blind, randomized, vehicle-controlled study, 50 patients with photodamaged facial skin (at least mild fine wrinkling and mottled hyperpigmentation, with at least one of these being moderate) were randomized to apply tazarotene 0.1% cream or vehicle cream to their face, once daily for 24 weeks.

Results: Blinded assessments showed that tazarotene was less likely than vehicle to be associated with an increase in keratinocytic and melanocytic atypia, and more likely than vehicle to be associated with a reduction in atypia. Between-group comparisons in distribution of change from baseline categories of severity were in favour of tazarotene (P = 0.055 for keratinocytic atypia, P = 0.034 for melanocytic atypia, and P < 0.001 for the number of granular cell layers). Compared with vehicle, tazarotene was associated with an increase in epidermal polarity (P = 0.008) and epidermal thickness (P = 0.012), and a tendency for stratum corneum compaction. Tazarotene was also associated with widened intercellular spaces (reported as epidermal oedema) relative to vehicle (P < 0.001).

Conclusions: Treatment of photodamaged skin with tazarotene is associated with an amelioration of keratinocytic and melanocytic atypia, an improvement in epidermal polarity, and an increase in epidermal thickness.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Double-Blind Method
  • Facial Dermatoses / drug therapy*
  • Facial Dermatoses / pathology
  • Female
  • Humans
  • Hyperpigmentation / drug therapy*
  • Hyperpigmentation / pathology
  • Keratinocytes / pathology
  • Keratolytic Agents / adverse effects
  • Keratolytic Agents / therapeutic use*
  • Male
  • Melanocytes / pathology
  • Middle Aged
  • Nicotinic Acids / adverse effects
  • Nicotinic Acids / therapeutic use*
  • Pharmaceutical Vehicles / adverse effects
  • Pharmaceutical Vehicles / therapeutic use
  • Severity of Illness Index
  • Skin Aging / drug effects*
  • Skin Aging / pathology
  • Treatment Outcome

Substances

  • Keratolytic Agents
  • Nicotinic Acids
  • Pharmaceutical Vehicles
  • tazarotene