Safety, acceptability, and tolerability of 3 topical microbicides among heterosexual Kenyan men.
OBJECTIVE
To compare the acceptability, tolerability, and safety of 3 topical microbicide formulations (62% ethyl alcohol in emollient gel and 0.1% and 0.4% benzalkonium chloride on a sanitary wipe) for use on male genitalia.


METHODS
This triple-randomized crossover study among men attending a sexually transmitted disease (STD) clinic in Nairobi, Kenya assigned individuals without clinical evidence of an STD to apply products to the penis in a predetermined random order, each for a 2-week period with a 1-week washout period between each product. Men recorded side effects and were examined for adverse events.


RESULTS
Of 39 participants, 33 (84%) completed 6 clinic visits plus 3 home visits by community health workers. Participants reported use of 62% ethanol gel and 0.1% and 0.4% benzalkonium on 99%, 99%, and 96% of daily scheduled applications; 99%, 98%, and 97% of preintercourse applications, and 99%, 94%, and 98% of postintercourse applications. All participants said they would recommend all 3 products to a friend; 72% preferred the 62% ethanol gel, 17% the 0.1% benzalkonium, and 11% the 0.4% benzalkonium. One person developed objective signs of a genital ulcer after 14 days of 0.4% benzalkonium wipe use.


CONCLUSIONS
Two of the 3 topical microbicides had minimal reported adverse effects, and no adverse effects were observed during use of the ethanol gel, which was preferred by most men.
Bukusi
Elizabeth A
EA
Kenya Medical Research Institute, Nairobi, Kenya.
Steele
Matthew
M
Cohen
Craig R
CR
Nguti
Rosemary
R
Maingi
Charity W
CW
Thomas
Katherine K
KK
Holmes
King K
KK
D000279:Administration, Cutaneous; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001548:Benzalkonium Compounds / Q000737:chemistry; D018592:Cross-Over Studies; D004643:Emollients; D000431:Ethanol / Q000737:chemistry; D005837:Genitalia, Male / Q000187:drug effects; D020010:Heterosexuality; D006801:Humans; D007630:Kenya; D008297:Male; D017060:Patient Satisfaction; D010413:Penis / Q000187:drug effects; D010865:Pilot Projects; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D001548:Benzalkonium Compounds; D004643:Emollients; D000431:Ethanol