The efficacy and safety of 2% clindamycin phosphate vaginal gel in the treatment of bacterial vaginosis (BV)

2% Clindamycin Phosphate Vaginal Gel is a thermosetting bioadhesive formulation containing 2% clindamycin phosphate. This vaginal gel is used to treat bacterial vaginosis (BV). It is also available as a cream and studies have shown that 2% clindamycin vaginal cream is more effective than trisulfamide vaginal cream in the treatment of bacterial vaginosis. However, it should not be used to treat vaginal irritation caused by yeast infections or sexually transmitted diseases such as chlamydia and trichomoniasis.

A single dose of 2.0% clindamycin phosphate gel (5 grams total) was administered in a pre-filled vaginal applicator to eligible patients in a clinical single-centre, single-arm, open study. Patients returned to the clinic 7 to 14 days (visit 2) and again 21 to 30 days (visit 3) after administration. Two subjects were excluded from the calculation of the cure rate. Of the 28 patients evaluable, 24 (86%) were successfully treated with a single dose of 2% clindamycin gel at the 2nd visit (clinical cure). Bacteriological cure could be assessed in 7 of the 10 patients evaluated with a Nugent score. Following a single dose of 2% clindamycin gel, 4 of 7 (57%) had a bacteriological response and 4 of 7 (57%) had a therapeutic response. Of the 24 women who completed the 2nd examination and were cured according to the Amsel criteria, 23 (96%) remained cured at the 3rd examination. Of the 10 patients evaluated using the Nugent Scale (bacteriological assessment), 7 of 9 (78%) had a score of 3 or less at the 3rd visit. In this group, six of the nine women (67 per cent) were considered cured by treatment.

It is worth noting that there were no adverse reactions reported during the course of the study, including local reactions to the vaginal gel product. And phase 1 clinical studies of the drug also showed that a single dose of 2% Clindamycin phosphate vaginal gel was well tolerated.

References:

[1] A. DUPRE; D. F; H Alur. Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis[J]. Clinical and experimental obstetrics & gynecology, 2020. DOI:10.31083/j.ceog.2020.04.5304.

[2] CHRISTINE K MAUCK. A Phase 1 pharmacokinetic study of a single-dose bioadhesive clindamycin 2% gel for bacterial vaginosis.[J]. Journal of Antimicrobial Chemotherapy, 2022. DOI:10.1093/jac/dkac386.

[3] W. MCCORMACK. Comparison of Clindamycin Phosphate Vaginal Cream With Triple Sulfonamide Vaginal Cream in the Treatment of Bacterial Vaginosis[J]. Sexually transmitted diseases, 2001. DOI:10.1097/00007435-200110000-00003.

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