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Allergic contact dermatitis from doxepin cream. One-year patch test clinic experience
J S Taylor1, P Praditsuwan, D Handel
1Department of Dermatology, Cleveland Clinic Foundation, Ohio, USA.
Archives of Dermatology
|May 1, 1996
Summary
Doxepin cream, previously thought to be low risk, caused allergic contact dermatitis in 17 patients. This study confirms doxepin cream is a contact sensitizer, especially on inflamed skin, and oral doxepin should be avoided in allergic patients.
Area of Science:
- Dermatology
- Allergology
- Contact Dermatitis
Background:
- Topical antihistamines can cause contact allergy.
- Doxepin cream was marketed with a "low risk of irritation and sensitization" claim based on premarket testing.
- Routine patch testing is crucial for identifying contact allergens in dermatological preparations.
Purpose of the Study:
- To evaluate the sensitization potential of doxepin cream in a clinical patch test setting.
- To identify patients with allergic contact dermatitis to doxepin cream.
- To assess the safety of using doxepin cream on inflamed skin.
Main Methods:
- Patch testing 97 patients with various pruritic dermatoses using doxepin cream and standard screening trays.
- Performing ingredient testing and open-application use tests for patients with positive reactions.
- Analyzing patch test results to confirm allergic contact dermatitis to doxepin cream.
Main Results:
- 17 out of 97 patients showed relevant positive patch test reactions to doxepin cream.
- Allergic contact dermatitis to doxepin cream was confirmed in 13 patients through ingredient and use tests.
- Positive reactions to doxepin hydrochloride and the whole formulation were observed, indicating sensitization.
Conclusions:
- Doxepin cream acts as a contact sensitizer, particularly on inflamed skin.
- The study challenges previous claims of low sensitization risk for doxepin cream.
- Patients diagnosed with doxepin contact allergy should avoid oral doxepin to prevent systemic reactions.