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Human Leukocyte Interferon‐α in a Hydrophilic Cream versus in a Gel for the Treatment of Genital Herpes in Males: A Placebo‐Controlled, Double‐Blind, Comparative Study
Author(s) -
Syed Tanweer A.,
Ahmadpour Oliver Abbas,
Ahmad Seyed Ali,
Ahmad Seyed Hamzeh
Publication year - 1997
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/j.1346-8138.1997.tb02293.x
Subject(s) - tolerability , medicine , placebo , erythema , myalgia , sex organ , gastroenterology , adverse effect , surgery , pathology , alternative medicine , biology , genetics
The aim of this double‐blind, placebo‐controlled, comparative study was to differentiate the clinical efficacy and tolerability of human leukocyte interferon‐α incorporated (2 times 10 6 IU/g) in a hydrophilic cream and in a gel to heal males afflicted with first episodes of genital herpes. Patients (n=60), aged 18–40 years (mean 23.2) with culture‐confirmed diagnosis of herpes genitalis were randomized to three parallel groups. Each patient was allocated a precoded 40‐g tube, containing either preparation or placebo. Cream or gel was applied three times daily for 5 consecutive days. The duration of the active treatment was two weeks. Patients were examined after 48 hours of initial treatment, and thereafter two times a week. A reepithelialized lesion with some residual erythema was recorded as healed. The study demonstrated that patients treated with leukocyte interferon‐α cream had both significantly shorter mean duration of lesions than gel and placebo recipients (5.3 days vs. 8 days, 13 days respectively; p<0.001) and a higher number of healed patients (80% vs. 55%, 20% respectively; p<0.001). Of the 60 patients, 49 (82%) complained of no drug‐related side effects. Eleven patients predominantly in the cream/gel groups reported non‐objective transitory increase in their body temperature (>38°C) with moderate headache, malaise and myalgia. The study was followed‐up for 24 months after the first day of the treatment, and out of 31/60 cured patients, 4 had a relapse after 18 months. In conlusion the study affirmed that human leukocyte interferon‐α (2 times 10 6 IU/g) in a hydrophilic cream is more efficacious than its incorporation in gel or placebo, thus suggesting that leukocyte interferon‐α in a hydrophilic cream, with a profile of non‐objective mild to moderate drug‐induced indications, may be considered an alternative and effective treatment modality to cure male patients afflicated with first episodes of genital herpes.