Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see CLINICAL STUDIES]. In these studies, 50% of the subjects who were treated with Atralin (tretinoin) Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.
Selected adverse reactions that occurred in at least 1% of subjects in the two studies combined, are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin (tretinoin) Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persists throughout the treatment period.
Table 1. Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)
(n = 674)
(n = 487)
|Dry Skin||109 (16%)||8 (2%)|
|78 (12%)||7 (1%)|
|53 (8%)||8 (2%)|
|Erythema||47 (7%)||1 (< 1%)|
|Pruritus||11 (2%)||3 (1%)|
|Pain of Skin||7 (1%)||0 (0%)|
|Sunburn||7 (1%)||3 (1%)|
Read the Atralin (tretinoin) Side Effects Center for a complete guide to possible side effects »
When treating with Atralin (tretinoin) Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin (tretinoin) Gel is begun.
Last reviewed on RxList: 8/16/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Atralin Information
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