Tazarotene

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

Machtiner LA, Kaidbey K, Lim J, et al. British Journal of Dermatology. 2004;151:1245-1252.

Summary

The authors present a multicenter, double-blind, randomized, vehicle-controlled study to evaluate the histological effects of tazarotene cream in patients with photodamaged facial skin. Photodamaged facial skin was defined by the authors as mild fine wrinkling and mottled hyperpigmentation with at least one of these at a moderate level. Fifty patients were enrolled and randomized to receive either tazarotene or vehicle cream. Study medications were applied once daily for 24 weeks. All of the patients were Caucasian and 41 were female. The level of photodamage was approximately equal in both treatment groups. A 3-mm punch biopsy was taken at baseline and at week 24 from a representative area of photodamaged skin. These biopsies were evaluated by a single dermatopathologist who was blinded to the treatment group and as to whether a specimen was pre- or post-treatment. The primary outcome assessments were the distribution and severity of both keratinocytic and melanocytic atypia. Between-group comparisons showed a difference in the distribution or severity of both keratinocytic and melanocytic atypia in favor of the tazarotene-treated group, although this did not reach statistical significance. Of the secondary outcomes evaluated, there was a statistically significant difference in favor of the tazarotene group for increasing epidermal edema, number of granular cell layers, mean epidermal polarity scores, and epidermal thickness. Clinically, there was a statistically significant difference in favor of the tazarotene group in the overall assessment of photodamage.

Comment

This was a well-designed multicenter study that provided histological assessments of the effects of tazarotene cream as compared to vehicle. In assessing keratinocytic and melanocytic atypia, statistical significance was not reached though the between-group comparison did favor tazarotene. Statistical significance was reached in regard to epidermal polarity and thickness of the granular cell layer and epidermis, all of which suggest an improvement from the photodamage at baseline. It is also important to recognize that there was a statistically significant clinical improvement regarding the overall assessment of photodamage. A self-evaluation by the patient would have been of interest, though histological effects were the main objective of this study. In addition, all patients were Caucasian and of skin type I-IV. Thus these results cannot be generalized to people of different races and darker skin types.

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COPYRIGHT 2005 Journal of Drugs in Dermatology, Inc.
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