Recommendations for a Skin Sensitization Study Modified Draize Test

Recommendations for a Skin Sensitization Study (Modified Draize Test) 

The study should be a randomized, controlled study on three test products the test transdermal patch, the innovator patch, and the placebo patch (transdermal patch without the active drug substance). 

Test sites should be randomized among patients. The study is divided into three sequential periods. 

Applications of the test materials should be made to the same skin sites three times weekly for 3 weeks, for a total of nine applications. The patches should remain in place for 48 hours on weekdays and for 72 hours on weekends. Scoring of skin reactions and patch adherence should be performed by a trained and blinded observer at each patch removal, using an appropriate scale. 

Dermal reactions should be scored on a scale that describes the amount of erythema, edema, and other features indicative of irritation. (See Appendix A for an example of a scoring system that can be used.) The percentage adherence of the transdermal patches should be assessed using a 5-point scale (see Appendix B). 

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