Clinical Trials Experience
Because clinical trials are conducted under prescribing 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 Trials]. In these studies, 50% of the subjects who were treated with Atralin 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 trials combined are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin 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%)|
|Peeling/Scaling/ Flaking Skin||78 (12%)||7 (1%)|
|Skin Burning Sensation||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%)|
The following adverse reactions have been identified during post-approval use of Atralin Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Temporary hyper-or hypopigmentation has been reported with repeated application of tretinoin.