Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.


Zorac (EpiPharm)
0.1% and 0.05% cream in 30 g tubes
Approved indication: psoriasis, acne
Australian Medicines Handbook section 8.2.1

Topical treatments are first-line therapy for acne and plaque psoriasis. The options for acne include the retinoids such as adapalene and tretinoin. Tazarotene is a retinoid which has been available overseas for several years. As tazarotene modulates the proliferation and differentiation of keratinocytes it has been studied in psoriasis and acne.

Early clinical trials compared a gel formulation with applications of inactive vehicle. Tazarotene reduced the severity of psoriasis in 45–63% of lesions depending on the concentration of the gel and whether it was applied once or twice a day. Only 13% of lesions responded to the vehicle.1 Over 12 weeks the cream formulation produced a clinical improvement in the skin of 49% of patients with facial acne compared with 33% of those given the vehicle.2

The efficacy of a once-daily application of gel was compared with that of twice-daily fluocinonide, a potent topical corticosteroid for psoriasis. After 12 weeks there was no significant difference between the treatments. Patients who responded to tazarotene were less likely to relapse in the 12 weeks after treatment stopped.3

A retrospective study evaluated the effect of topical retinoids in inflammatory facial acne. Clinically significant improvements were judged to have occurred in 36% of the evaluations of patients given tazarotene, 34% of evaluations of adapalene and in 28% of the evaluations of tretinoin. Only 17% of the evaluations considered that there had been a response to a vehicle.4

Tazarotene is a prodrug which is converted to tazarotenic acid. Some of this is absorbed into the systemic circulation then excreted in the urine and faeces. As retinoids are teratogenic, tazarotene should not be used in pregnancy or in women who could become pregnant during treatment.

Common complaints reported in trials of tazarotene include a burning or stinging sensation, itching, irritation, redness and dry skin. Patients should be advised to use sunscreens. Those with acne are likely to develop desquamation. The safety and efficacy of tazarotene have not been established beyond 12 weeks of treatment.

There have been studies of tazarotene in combination regimens, but there do not appear to have been many published comparisons with other treatments. In acne tazarotene is an alternative to the other retinoids and it can probably be considered in psoriasis for patients who have not tolerated or not responded to other topical treatments.

Read about The Transparency Score manufacturer provided some data

The Transparency Score () is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.

Notes on references

At the time the comment was prepared, information about this drug was available on the website of the Food and Drug Administration in the USA (www.fda.gov).

At the time the comment was prepared, a scientific discussion about this drug was available on the website of the European Agency for the Evaluation of Medicinal Products (www.emea.eu.int).

References

  1. Krueger GG, Drake LA, Elias PM, Lowe NJ, Guzzo C, Weinstein GD, et al. The safety and efficacy of tazarotene gel, a topical acetylenic retinoid, in the treatment of psoriasis. Arch Dermatol 1998;134:57-60.
  2. Shalita AR, Berson DS, Thiboutot DM, Leyden JJ, Parizadeh D, Sefton J, et al. Effects of tazarotene 0.1% cream in the treatment of facial acne vulgaris: pooled results from two multicenter, double-blind, randomized, vehicle-controlled, parallel-group trials. Clin Ther 2004;26:1865-73.
  3. Lebwohl M, Ast E, Callen JP, Cullen SI, Hong SR, Kulp-Shorten CL, et al. Once-daily tazarotene gel versus twice-daily fluocinonide cream in the treatment of plaque psoriasis. J Am Acad Dermatol 1998;38:705-11.
  4. Leyden JJ, Shalita A, Thiboutot D, Washenik K, Webster G. Topical retinoids in inflammatory acne: a retrospective, investigator-blinded, vehicle-controlled, photographic assessment. Clin Ther 2005;27:216-24.