Single-dose clindamycin gel highly effective treatment of bacterial vaginosis in women
USA: A novel, single-dose clindamycin vaginal gel is a highly effective and safe treatment modality for bacterial vaginosis in women, states an article published in Obstetrics & Gynecology.
Bacterial vaginosis, caused by an imbalance of the naturally occurring vaginal flora, is the most common vaginal infection, found in an estimated 5 to 70% of women of reproductive age. Symptoms include a thin white or grey vaginal discharge; pain, itching, or burning in the vagina; a strong fish-like odor. It is associated with an increased risk of pelvic inflammatory disease, infertility, adverse pregnancy outcomes, and sexually transmitted infections including HIV. XACIATO, a thermosetting bioadhesive intravaginal gel formulated with 2% clindamycin phosphate, designed to release the active ingredient for an extended period was approved by the U.S. FDA for bacterial vaginosis treatment.
C Mauck, Daré Bioscience, Inc., California, and colleagues conducted a randomized study to assess the efficacy and safety of a single-dose vaginal clindamycin gel for bacterial vaginosis treatment.
Researchers randomly assigned 307 women with bacterial vaginosis to the 2% clindamycin gel(n=188)group and to the placebo (n=94) group. Eligibility criteria were clinical diagnosis of bacterial vaginosis(all four Amsel's criteria, without other genital infections) and Nugent scores of 7–10. The evaluation was done at screening, day 7–14, and day 21–30 (test of cure). Clinical cure was defined as resolution of three of four Amsel's criteria, bacteriologic cure as Nugent score lower than 4, and therapeutic cure as both clinical and bacteriologic cure.
The primary outcome was set as a clinical cure at the test-of-cure visit. Secondary endpoints were clinical cure on day 7–14, bacteriologic and therapeutic cures on day 7–14, and test of cure.
Key findings of the study,
• Overall, 70.5% and 35.6% of the patients in the clindamycin and placebo groups achieved a clinical cure, respectively.
• Statistically significant differences between groups were seen for all secondary endpoints
• Approximately 15% of patients in the clindamycin group and 9.7% of patients in the placebo group experienced one or more treatment-related, treatment-emergent adverse events. Vulvovaginal candidiasis was observed as the most frequent one.
• Side effects including pruritus (37.4%), burning or stinging (21.7%), and vulvovaginal pain (10.8%) were reported.
• There were no findings of concern among hematologic, serum biochemistry, or urinalysis results.
• There were no clinically relevant changes in vital signs or physical examination results
The authors concluded that single-dose clindamycin vaginal gel was highly effective with a clinical cure rate of 70% and safe for women disproportionately affected by bacterial vaginosis, with Nugent scores of 7–10 at the start of the study.
The study showed clindamycin gel has the same cure rates as topical metronidazole gel had in other studies but showed no serious adverse effects. Thus, single-dose clindamycin gel could be a reasonable alternative to topical metronidazole in the clinical setting, although a trial is needed to truly assess for noninferiority, the authors suggested.
Reference:
Mauck, Christine MD, MPH; Hillier, Sharon L. PhD; Gendreau, Judy MD; Dart, Clint MS; Chavoustie, Steven MD; Sorkin-Wells, Valerie MD; Nicholson-Uhl, Clifton MD; Perez, Brandon MD; Jacobs, Mark MD; Zack, Nadene MS; Friend, David PhD Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis, Obstetrics & Gynecology: June 2022 - Volume 139 - Issue 6 - p 1092-1102 doi: 10.1097/AOG.0000000000004805
