Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm

OBJECTIVES: To assess the safety and acceptability of 2 vaginal microbicide gels (Acidform and BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm among low-risk, sexually abstinent women. STUDY DESIGN: Eighty-one women enrolled in a randomized, masked, phase I safety study using a diaphragm with Acidform, BufferGel, or KY Jelly for 6 to 10 hours nightly for 14 nights. Physical examination, colposcopy, and lab studies were performed after 1 and 2 weeks of use. Diaries and questionnaires were used to assess user acceptability. RESULTS: Sixty-nine participants (85%) completed the study. Safety and acceptability appeared similar among the 3 study groups and no serious adverse events related to the study products were reported. Adverse events were mild and anticipated. CONCLUSIONS: Acidform and BufferGel compared to KY Jelly, when used with diaphragm daily for 14 days, appeared to be safe and acceptable in a small study of low-risk abstinent women.     

A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand

OBJECTIVES: To determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men. STUDY DESIGN: We conducted a 6-month randomized, placebo-controlled trial among sexually active, couples at relatively lower risk for HIV infection in northern Thailand. METHODS: Women inserted 1 applicator of study gel vaginally every time the couple had sex. Safety was assessed by symptom report and genital examination of both partners and by changes in vaginal flora. Acceptability was assessed by participant interview. RESULTS: Overall, 55 couples were randomized, 28 to Carraguard use and 27 to the methyl-cellulose placebo gel group. Retention and study gel use were similarly high in both study groups; use of gel without condoms was reported in more than 95% of vaginal sex acts. The 2 study groups were similar in the proportions of women and men with symptoms or with genital findings without epithelial disruption, of men with findings with epithelial disruption, and of women with abnormal genital flora, whereas more women in the placebo group had findings with epithelial disruption. Women and men in both groups reported that the gel and applicator were acceptable. CONCLUSIONS: Carraguard can safely be used an average of 2 to 3 times per week during sex and is acceptable to Thai women and men.     

Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide

BACKGROUND AND OBJECTIVES: Potential rectal microbicides, as an adjunct to condoms for HIV/STD prevention, have not been studied previously. GOAL OF THIS STUDY: Advantage 24 (1.5 ml of a bioadhesive gel containing 52.5 mg nonoxynol-9 administered by single-use applicator)-under investigation as a vaginal microbicide-was evaluated for acceptability among male couples. STUDY DESIGN: Twenty-five HIV-negative and 10 HIV-positive male couples participated in a frequency use escalation trial. Diaries and self-administered questionnaires assessed product use, acceptability, sexual behavior, and gastrointestinal and urologic side effects. RESULTS: Excluding participants who felt no need for an HIV prevention method, 58% said they would use Advantage 24 if approved for rectal use; 69% of receptive users reported rectal fullness and related side effects after insertion of the gel, and 68% reported applicator-related discomfort; 59% of insertive participants found the gel too sticky. CONCLUSIONS: Acceptability remains inconclusive and warrants further study of redesigned applicators and ways to minimize rectal side effects.     

Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide

OBJECTIVE: We sought to determine the safety and acceptability of vaginal gel formulation PC-503 among low risk, abstinent women. The active ingredient was 2% pharmaceutical grade lambda carrageenan, a sulphated polymer that is generally recognised as safe by the US Food and Drug Administration. METHODS: 35 women in five sites applied 5 ml of the PC-503 gel vaginally once a day for 7 days while abstaining from sexual intercourse. Visual vaginal examinations were performed on days 1, 4, and 8. STI testing and vaginal pool Gram stain preparations were done on days 1 and 8. Participants were asked about product acceptability. RESULTS: 34 of the 35 women enrolled completed 7 days' use. Following product use, five reported mild symptoms including "bladder fullness," "genital warmth," or discomfort, and lower abdominal pain, and one had moderate pale yellow cervical discharge. Using the Nugent criteria, three women had bacterial vaginosis (BV) before and after use; three had BV before but not after, and two had BV after but not before. Most of the women found PC-503 to be pleasant or neutral in feel and smell and considered extra lubrication to be an advantage; however, one third found it to be messy. CONCLUSIONS: Vaginal use of PC-503 gel did not cause significant adverse effects in a small number of low risk, sexually abstinent women. Further testing in larger numbers of sexually active women is planned. A smaller volume of gel may be more acceptable to some women.     

A randomized six-day safety study of an antiretroviral microbicide candidate UC781, a non-nucleoside reverse transcriptase inhibitor

GOAL: This study evaluated the effect of a single dose and 5 additional consecutive daily doses of UC781 gel at concentrations of 0.1%, 0.25%, 1.0%, and 0% on urogenital irritation. STUDY DESIGN: Forty-eight healthy sexually abstinent women were randomly assigned to 1 of 4 groups. METHODS: Urogenital irritation was assessed by pelvic examination, colposcopy, and reports of genital symptoms at baseline and after 1 and 6 doses. Vaginal health was assessed by wet mount and systemic safety by laboratory evaluation after 1 and 6 doses, and UC781 levels were assessed at baseline and after 6 doses. RESULTS: Some evidence of urogenital irritation was common in all treatment groups and was most often transient and mild. Colposcopic findings were infrequent in the placebo group (8%) and more common in the 3 treatment groups (24%-42%). Edema, which may indicate underlying inflammation, was observed in the vaginal fornix of 2 women exposed to UC781. There was no apparent increase in vaginal infection or clinically significant changes in laboratory values. Two of 12 participants randomized to 1% UC781 gel had detectable plasma levels that were less than the lower level of quantification. CONCLUSIONS: UC781 was well tolerated in this initial dose ranging safety study when used once daily for 6 days in sexually abstinent women. Five safety/pharmacokinetic studies of UC781 are currently underway in women and men, all utilizing UC781 concentrations less than 1%, with twice-daily dosing in some studies, and all involving careful monitoring of exposed epithelium.     

Microbicide acceptability among high-risk urban U.S. women: experiences and perceptions of sexually transmitted HIV prevention

OBJECTIVES: The objectives of this study were to measure microbicide acceptability among high-risk women in Hartford, Connecticut, and contextual factors likely to affect acceptability and use. GOAL: The goal of this study was to assess usefulness of microbicides for HIV/sexually transmitted infection (STI) prevention for high-risk women. STUDY: Ethnographic interviews (n = 75) and a survey (n = 471) explored women's perspectives on HIV/STI prevention, vaginal contraceptives similar to microbicides, and microbicide acceptability. Participants (n = 94) in a 2-week behavioral trial used an over-the-counter vaginal moisturizer to simulate microbicide use during sex with primary, casual, and/or paying partners. RESULTS: Findings showed limited experience with vaginal contraceptives, but high interest in microbicides as an alternative to condoms, indicated by an acceptability index score of 2.73 (standard deviation, 0.49; scale of 1-4) in the overall sample. General microbicide acceptability varied by ethnicity, prior contraceptive and violence/abuse experiences, relationship power, and other attitudinal factors. The simulation trial indicated significant willingness to use the product in various locations and with all types of partners. CONCLUSIONS: Vaginal microbicides may improve prevention outcomes for high-risk inner-city women.     

Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial

Background Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV‐1) recurrences but may not alleviate functional symptoms. Objectives To assess the efficacy and safety of CS20 (Acura 24^®) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV‐1 labial recurrences. Methods A prospective, randomized, single‐centre, assessor‐blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes‐related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores. Results In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1–2) or placebo (Days 1–7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1–6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups. Limitations The single‐centre and single‐blind design of the study and the preselection of patients. Conclusion CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV‐1 labial recurrences and was similar to aciclovir for time to cure.     

Meta-analysis of 5% imiquimod and 0.5% podophyllotoxin in the treatment of condylomata acuminata

BACKGROUND: Genital warts are a common sexually transmitted disease caused by human papillomaviruses. Podophyllotoxin 0.5%, approved for patient self-administration, has been used most extensively in the treatment of genital warts. Imiquimod, a novel immune response modifier capable of inducing interferon-alpha and a variety of cytokines, has been examined as a potential treatment for genital warts. But 0.5% podophyllotoxin and 5% imiquimod have not been compared in any extensive and formal studies, although they are the common topical agents for genital warts. OBJECTIVE: To evaluate the efficacy and safety of topical 5% imiquimod and 0.5% podophyllotoxin in the treatment of genital warts. METHODS: We searched Medline (1966 to June 2005), Embase (1974 to June 2005) and the Cochrane Controlled Trials Register (issue 3, 2005). Randomized controlled trials of 5% imiquimod or 0.5% podophyllotoxin in the treatment of genital warts were collected. Two reviewers extracted the data and independently assessed the quality of the included medical literature. Then, meta-analysis was conducted. RESULTS: Twelve studies including 3 placebo-controlled trials of imiquimod and 9 placebo-controlled trials of podophyllotoxin were included. The clinical cure rates of imiquimod and podophyllotoxin were 50.34 and 56.41%, respectively, without statistically significant differences between the two (p > 0.05). A combined analysis of the 3 studies on imiquimod showed a statistically significant difference to the placebo group [pooled odds ratio (OR) 11.65, 95% confidence interval (CI) 6.05-22.44], as did a combined analysis of the 9 studies on podophyllotoxin (pooled OR 16.70, 95% CI 7.06-39.48). The most common adverse events of imiquimod were erythema, erosion, excoriation, itching and burning; those of podophyllotoxin were burning, pain, erosion, itching and inflammation. CONCLUSION: Imiquimod and podophyllotoxin possess similar curative effects on condylomata acuminata but podophyllotoxin has more serious adverse effects.     

Amcinonide vs. betamethasone dipropionate ointments in the treatment of psoriasis

A randomized, double-blind study compared the efficacy and safety of amcinonide and betamethasone dipropionate ointments, applied twice daily for two weeks, in the treatment of patients with moderate to severe psoriasis. Thirty-four patients were enrolled; thirty patients had had psoriasis for more than one year, and in the majority of patients, it was stable or slowly exacerbating. Significant improvement from baseline was observed with both ointments at weeks 1 and 2. The two drugs showed comparable cosmetic acceptability. Adverse cutaneous symptoms experienced were burning (both groups), itching (amcinonide), and stinging (beta-methasone); no serious adverse effects were reported.     

Acceptability of hypothetical microbicides among women in sex establishments in rural areas in Southern China

OBJECTIVES AND GOAL: The objectives of this study were to measure the potential acceptability of a hypothetical microbicide among women in sex establishments in rural areas of Southern China and demographic, behavioral, and social context factors likely to affect microbicide acceptability. STUDY DESIGN: This was a cross-sectional survey, using a quota sampling, among 300 women from sex establishments in 3 rural towns. An interviewer-administered standardized questionnaire was used to measure the acceptability score of hypothetical microbicides' characteristics, as well as sexual relationships and behaviors and other contextual factors. RESULTS: Findings showed a generally positive response to microbicides, indicated by an acceptability index score of 2.89 (SD, 0.56, scale of 1-4) in the overall sample. Multivariate analysis shows that the acceptability score varied significantly by study sites, type of sex-work establishments, marital status, sex partner type, vaginal product experience, locus of control by partners, and locus of control by chance. CONCLUSIONS: Microbicides may be acceptable among sex workers in rural settings in China; however, contextual factors should be carefully considered in education and promotion of microbicides in the future.     

A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women

BACKGROUND: Although the male condom provides a reliable means of preventing HIV transmission, a broader choice of methods is required particularly in circumstances where the negotiation of condom use is difficult. Development of new products that may be effective as topical vaginal microbicides is the focus of a great deal of research activity currently. The novel agent PRO 2000, a naphthalene sulphonate derivative with in vitro activity against HIV and other sexually transmissible pathogens, is one such compound. We have studied the local and systemic safety and tolerance of a vaginal gel formulation of this agent at two concentrations (0.5% and 4%) over a 2 week period of daily exposure in two cohorts of healthy sexually abstinent women (one in London, UK, and the other in Antwerp, Belgium). METHODS: This was a randomised, placebo controlled, double blind, three arm clinical trial conducted on two sites. Macroscopic evidence of genital epithelial changes was sought using colposcopy and evidence of microscopic inflammation was acquired using high vaginal biopsy from predetermined sites (UK cohort only). Blood levels of PRO 2000 were measured and laboratory safety tests, including coagulation screens, were performed. The impact on vaginal ecology was also assessed. RESULTS: 73 women were enrolled across both sites (36 UK, 37 Belgium); 24, 24, 25 in the 4%, 0.5%, and placebo groups respectively. Of these, 70 completed 2 weeks' exposure to the study gel. Three (all in the 4% group) withdrew owing to adverse events which were possibly or probably gel related. Cervicovaginal abrasion was seen colposcopically in three subjects after 14 days of gel use (two in the 4% group and one in the placebo group). Genital ulceration was not seen during gel use in any of the subjects who completed the study. Histological evaluation of vaginal biopsy samples (36 women only) showed evidence of increased inflammatory signs in one participant of the 4.0% group. One volunteer in the placebo group had moderate inflammation at screening and at follow up. Severe inflammation was not seen among any of the subjects tested. Plasma levels of PRO 2000 and laboratory safety tests showed no evidence of systemic absorption. No impact was seen on normal vaginal ecology in the UK cohort where samples were taken 12 hours after the last gel application. CONCLUSION: In this phase I study PRO 2000 gel was found to be generally well tolerated with promising local and systemic safety profiles. The 0.5% gel was better tolerated than the 4% gel as fewer genital epithelial adverse events were seen in the former. Phase II studies are about to begin in sexually active women.     

Prevention of signs and symptoms of dermographic urticaria by single-dose ebastine 20 mg

In dermographic urticaria (DU), shearing forces on the skin result in weals and itching. Second-generation antihistamines are recommended as the first-line treatment, but to date only a few have ever been tested for this condition. The objective of this pilot study was to assess the safety and efficacy of ebastine in preventing symptoms of DU. Seven adult patients with DU participated in a double-blind cross-over trial of ebastine 20 mg. Safety was assessed using a sensitive psychometric battery, testing cognitive performance and mood. Efficacy was assessed by rating weals, erythema, pruritus and burning after challenge. Ebastine had no negative effective on cognitive performance or mood. Weals, pruritus and burning were greatly reduced for most subjects. This pilot study suggests that ebastine is safe and effective in preventing the symptoms of DU and should be tested on a larger scale.     

Vulvar pruritus and burning sensation in women with psoriasis

Approximately 80% of psoriatic individuals experience pruritus, of varying intensity. This study evaluated the frequency of vulvar itching and burning and its influence on well-being in women with psoriasis. A total of 93 women were included in the study. Psoriasis severity was assessed according to the Psoriasis Area and Severity Index, the intensity of vulvar discomfort by visual analogue scale and depressive symptoms by Beck's Depression Inventory. On admission 41 (44.1%) women experienced vulvar discomfort, 18 (19.4%) itching, 10 (10.8%) burning and 13 (14.0%) both itching and burning sensations. Psoriatic lesions on the vulva were found in 22 (23.7%) women. No significant correlation was found between burning or itching intensity and global psoriasis severity (r = 0.19, p = 0.26). Patients with vulvar discomfort had psoriatic lesions on the vulva more often than women without discomfort (43.6% vs. 8.2%, p < 0.001). In addition, patients with vulvar discomfort more frequently demonstrated depressive symptoms (p < 0.05). We conclude that vulvar discomfort is an important clinical problem in women with psoriasis and should be taken into consideration during treatment.     

Therapie des Lichen sclerosus et atrophicus vulvae mit dem CO2-Silk-touch-Laser

A 50 year old woman with distinct lichen sclerosus et atrophicus was suffering from severe genital itching, dyspareunia and increasing urinary burning. Therapy attempts with topical glucosteroids and estrogens had been without effort. Treatment with CO2 laser in silk touch mode under insufflation anesthesia to an improvement of her skin lesions and a nearly complete remission of her symptoms.     

Effect of chlorhexidine on genital microflora, Neisseria gonorrhoeae, and Trichomonas vaginalis in vitro

BACKGROUND: Chlorhexidine is a disinfectant that has been used in skin and mouth washes and as a preservative in some vaginal lubricants. A gel containing 0.25% chlorhexidine gluconate has been found to be effective against Chlamydia trachomatis in vitro and in animal models. Applied vaginally, 5 g of this gel could achieve vaginal fluid concentrations of < or = 1250 microg/ml. GOAL: To test the in vitro activity of chlorhexidine in a gel over a pH range of 4 to 8 in the presence or absence of blood. STUDY DESIGN: Organisms were exposed to chlorhexidine for 30 minutes to 2 hours, and the minimum cidal concentration (MCC) was calculated. RESULTS: The MCC for Neisseria gonorrhoeae was 25 microg/ml at 30 minutes and 12.5 microg/ml at 1 to 2 hours of exposure, whereas the MCC for Trichomonas vaginalis was 1250 microg/ml. Chlorhexidine was more active at pH 8 than pH 4, and less active in the presence of blood. The MCC for Lactobacillus crispatus was 1250 microg/ml at pH 4 and only 125 microg/ml at pH 8. CONCLUSIONS: Based on its in vitro activity, chlorhexidine may be an appropriate topical microbicide for prevention of gonorrhea, but not for prevention of trichomoniasis. This study suggests that the presence of blood and pH affect the activity of chlorhexidine against genital pathogens and commensals.     

High prevalence of Mycoplasma genitalium in the lower genitourinary tract of women attending a sexually transmitted disease clinic in Paris,France

BACKGROUND: Previous studies have suggested that Mycoplasma genitalium is associated with cervicitis and may be a cause of pelvic inflammatory disease. This study attempted to investigate further the possible role of M genitalium in genital symptoms of women attending a sexually transmitted disease (STD) clinic. GOAL: To determine the prevalence of and the association of clinical and microbiologic features with M genitalium in women presenting with genital symptoms. STUDY DESIGN: Between April 1994 and June 1996 a prospective study of 170 consecutive women with abnormal vaginal discharge, with or without urethral itching, dysuria, or pelvic pain, was conducted at the STD clinic at Saint-Louis Hospital in Paris. Information was collected on each subject's characteristics, and a clinical vulvar, vaginal, and cervical examination was performed. Cervical, vaginal, and urethral samples were obtained to identify infecting organisms. RESULTS: DNA of M genitalium was identified by polymerase chain reaction (PCR) at one or more genital sites in 65 women (38%; 95% CI, 31-46%) and was statistically more frequently detected in the vagina (39%) than in the cervix (21%) or urethra (28%) (P = 0.001 and 0.048, respectively). PCR inhibitors were detected in 17 specimens (4%). M genitalium was found in 6/14 (43%) positive for Chlamydia trachomatis, but no significant association between M genitalium and any demographic, clinical, or microbiologic data was noted in univariable or multivariable analysis. CONCLUSION: This study indicates that M genitalium is frequently encountered in the female genital tract and is not associated with cervicitis or any particular clinical or microbiologic data.     

Prevalence of vulval lichen planus in a cohort of women with oral lichen planus: an interdisciplinary study

BACKGROUND: Lichen planus (LP) is a mucocutaneous inflammatory dermatosis that frequently involves the oral and genital mucosae. Patients with LP affecting these sites are often seen by oral medicine specialists or gynaecologists who work in isolation and depend heavily on histopathologists to help them in confirming the diagnosis. There are few studies in the literature combining the experiences of these specialists who share the care of patients with both oral and genital LP. OBJECTIVES: To estimate the prevalence of vulval LP (VLP) in a cohort of patients with histologically confirmed oral LP (OLP). METHODS: The study group consisted of 42 women histologically diagnosed with OLP. The mean age was 60.5 years (range 27-81). They underwent genital examination, colposcopy and vulvoscopy. For the histological confirmation of clinical VLP biopsies were performed whenever a clinical lesion was found. Oral and genital biopsy specimens were processed through histological and immunohistochemical staining. Histological diagnoses of LP were made according to the modified World Health Organization histopathological criteria proposed by van der Meij and van der Waal for the diagnosis of OLP, and extended to VLP. Patients with clinical evidence, but without the histological confirmation of OLP and VLP, were excluded from the study group. RESULTS: Thirty-two vulval and one vaginal biopsy specimens were obtained. Histological diagnoses were confirmed in 24 of 32 (75%) patients who underwent a vulval biopsy: these represent 57% (24 of 42) of the study group. Of the 12 patients free of symptoms such as itching, burning and dyspareunia, but with clinical vulval lesions, 11 (92%) had histological confirmation of VLP. Vulval lichen sclerosus was ascertained in five of 32 (16%) cases. CONCLUSIONS: This study showed a 57% prevalence of VLP in selected patients with OLP. The high prevalence of VLP of 92% in the women who were free of vulval symptoms confirmed the usefulness of this careful integrated approach.     

合并非特异性感染的老年性阴道炎的临床治疗效果研究

目的:本研究旨在研究采取综合治疗对合并非特异性感染的老年性阴道炎的临床治疗效果,为临床有效治疗该类疾病提供参考。方法:选择医院在2012年11月至2014年11月期间妇科收治的272例老年性阴道炎合并非特异性感染患者为本研究观察对象,随机分为试验组和对照组,各136例,分别采取综合治疗及常规治疗方法,并比较其治疗效果。结果:经过4个疗程的治疗后,两组患者临床症状均有一定程度的改善,试验组白带正常、阴道分泌物减少、外阴瘙痒减轻无灼痛及黏膜无充血水肿患者发生率分别为86.76%、94.12%、89.71%、88.24%,明显优于对照组(69.12%、77.94%、72.06%、75.00%);试验组患者p H<4.5以及阴道洁净度Ⅰ~Ⅱ度的患者例数分别为65例(95.59%)及64例(94.12%),明显优于对照组(82.35%、86.76%);经过相应治疗后,两组患者均取得一定的治疗效果。试验组总有效率为92.65%,对照组总有效率为83.82%,试验组临床治疗效果明显优于对照组。结论:采取综合措施治疗老年性阴道炎合并非特异性感染患者,临床治疗效果显著,可从根本上达到消炎、抑菌、抗感染并提高患者阴道黏膜组织抵抗力的治疗目的,值得临床广泛应用推广。     

Tacrolimus ointment in the treatment of eyelid dermatitis

The safety and efficacy of tacrolimus ointment 0.1% (Protopic) in the treatment of atopic dermatitis of the eyelids were assessed in an open-label clinical trial of 21 patients with moderate to severe eyelid dermatitis. Of those 21 patients, 20 received study drug and were followed. Patients applied tacrolimus ointment 0.1% twice daily for 8 weeks and were followed for 2 additional weeks after the last day of treatment. Complete eye examinations were conducted throughout the study. Efficacy was assessed through the investigator's evaluation of the patients' individual signs and symptoms of eyelid dermatitis and the physician global assessment (PGA) of eyelid clinical response. Improvement in the investigator's evaluation of the signs and symptoms of eyelid dermatitis was observed during the study. A total of 80% of patients (16/20) experienced marked improvement or better in PGA at 8 weeks. Adverse events were limited to local burning and itching after the first few applications of study medication. Of the 20 patients, 12 reported burning (60%), and 5 reported itching (25%). There was no statistically significant increase in intraocular pressure (IOP) during the study compared with baseline. In addition, none of the patients developed cataracts or glaucoma during the study. In summary, tacrolimus ointment 0.1% may be a safe and effective treatment option for patients with moderate to severe eyelid dermatitis.     

A randomized trial of clinician-delivered interventions promoting barrier contraception for sexually transmitted disease prevention

OBJECTIVE: The objective of this study was to compare 2 interventions promoting condoms and vaginal microbicides to prevent sexually transmitted disease (STD). STUDY: Women (N = 427) attending an STD clinic were randomly assigned to 2 clinician-delivered interventions and followed up monthly to assess condom/microbicide use and incidence of gonorrhea, chlamydia, and syphilis. RESULTS: During follow up, condom use rates were 69% (enhanced) and 49% (basic) and microbicide use rates were 44% and 29%, respectively. STD rates did not significantly differ between intervention groups. Perfect condom use (regardless of intervention arm) was associated with a 3-fold decrease in STD rates (relative risk [RR], 0.3; 95% confidence interval [CI], 0.1-0.8). Using a vaginal microbicide during > or =50% of the acts of intercourse was associated with reduced STD rates (RR, 0.5; 95% CI, 0.3-1.0) across intervention groups and condom use categories. CONCLUSIONS: The enhanced intervention increased use of condoms and vaginal microbicide; however, STD rates did not decrease because a protective effect was seen only among perfect barrier users, and the enhanced intervention only modestly increased perfect use.