Abstract | BACKGROUND: OBJECTIVE: METHODS: A total of 270 patients with atopic dermatitis who had daily moderate to severe pruritus for at least 1 week were enrolled in the double-blind, vehicle-controlled, multicenter study. Treatment was randomly assigned: 5% doxepin cream or vehicle cream was applied twice on the day of the baseline visit and four times daily for the remainder of the 7-day trial. RESULTS: Relief of pruritus was achieved in 85% of doxepin-treated patients and 57% of vehicle-treated patients by day 7; a majority of these positive responses occurred during the first 24 hours. Pruritus severity scores demonstrated significantly greater improvement with topical doxepin at each study visit (p < 0.01). Visual analogue scales for pruritus severity and pruritus relief showed similar improvement in the doxepin-treated group. At each of three visits, the physician's global evaluation for relief of pruritus also showed significant improvement in the doxepin treatment group (p < 0.01). The physician's global evaluations of eczema significantly favored topical doxepin on day 7 (p < 0.01). Nineteen patients withdrew from the study because of adverse effects ( doxepin, n = 16; vehicle, n = 3). The most commonly reported were localized stinging or burning ( doxepin group, n = 39; vehicle group, n = 34) and drowsiness ( doxepin group, n = 37; vehicle group, n = 3), all of which decreased in frequency and severity over time. CONCLUSION: Topical doxepin is effective in reducing pruritus in patients with atopic dermatitis. It has an apparent short-term low risk of major side effects or sensitization.
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Authors | L A Drake, J D Fallon, A Sober |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 31
Issue 4
Pg. 613-6
(Oct 1994)
ISSN: 0190-9622 [Print] United States |
PMID | 8089287
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Pharmaceutical Vehicles
- Doxepin
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Topics |
- Administration, Cutaneous
- Adult
- Dermatitis, Atopic
(complications)
- Double-Blind Method
- Doxepin
(administration & dosage, adverse effects, therapeutic use)
- Eczema
(drug therapy, pathology)
- Female
- Humans
- Male
- Pharmaceutical Vehicles
- Pruritus
(drug therapy)
- Sleep Stages
(drug effects)
- Time Factors
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