SCHACKER T, CONANT M, THOMING C, STANCZAK T, WANG Z; Interscience Conference on Antimicrobial Agents and Chemotherapy (41st : 2001 : Chicago, Ill.).
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2001 Dec 16-19; 41: abstract no. H-1114.
Univ of MN, Minneapolis, MN
BACKGROUND: Imiquimod (Aldara) 5% cream is a topically-active immune response modifier that induces cytokines, including IFN-alpha. Methodology: To evaluate safety and efficacy, this randomized, double-blind, vehicle (placebo)-controlled, dose frequency varying study applied multiple applications of Aldara 5% cream topically to the skin of the external genitalia in the presence of herpetic lesions. Within 24 hours after development of a recurrence, patients began treatment with either Aldara or vehicle once, twice, or three times per week for three weeks. Patients treated all subsequent recurrences during the 16-week treatment period with their assigned regimen. Upon completion of the treatment period, patients entered a 16-week observation period. RESULTS: A total of 124 patients were randomized; 103 patients completed the treatment period and 93 completed the observation period. The median time to first recurrence was 53 days on vehicle (n=30) and 54, 60, and 64 days on Aldara 1x/week (n=34), 2x/week (n=32), and 3x/week (n=28), respectively. The median annualized recurrence rate during the treatment period was 3.8 on vehicle and 4.9, 3.2, and 3.1 for Aldara 1x/week, 2x/week, and 3x/week, respectively. There were no statistically significant differences for either parameter between vehicle and each of the Aldara treatment groups in the treatment or observation periods. For safety, there was a trend toward increased local adverse events at the application site and a delay in lesion healing in the more frequent Aldara dosing regimens. CONCLUSIONS: Despite evidence of a pharmacological effect in the more frequent dose groups as seen in increased local adverse events, there was no apparent efficacy in any of the Aldara groups.
Publication Types:
Keywords:
- Aminoquinolines
- Clinical Trials, Phase II as Topic
- Double-Blind Method
- Female
- Herpes Genitalis
- Humans
- Male
- Placebos
- Recurrence
- Vehicles
- imiquimod
Other ID:
UI: 102269288
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