Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis
The objective of the study was to evaluate the efficacy and safety of a novel single 2% clindamycin phosphate vaginal gel for the treatment of bacterial vaginosis (BV). The vaginal gel, a thermosetting bioadhesive formulation containing 2% clindamycin phosphate, was studied in a single center, singl...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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IMR Press
2020-08-01
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| Series: | Clinical and Experimental Obstetrics & Gynecology |
| Subjects: | |
| Online Access: | https://www.imrpress.com/journal/CEOG/47/4/10.31083/j.ceog.2020.04.5304 |
| _version_ | 1818552858581139456 |
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| author | A. Dupre H.H. Alur D.R. Friend |
| author_facet | A. Dupre H.H. Alur D.R. Friend |
| author_sort | A. Dupre |
| collection | DOAJ |
| description | The objective of the study was to evaluate the efficacy and safety of a novel single 2% clindamycin phosphate vaginal gel for the treatment of bacterial vaginosis (BV). The vaginal gel, a thermosetting bioadhesive formulation containing 2% clindamycin phosphate, was studied in a single center, single arm, open-label study. Patients (n = 30) were screened for BV using the four Amsel criteria (visit 1). A subset of ten women were also assessed using Nugent scores. Eligible patients were consented and provided a single dose of 2.0% clindamycin phosphate gel in a prefilled vaginal applicator (5-gram total dose). Patients returned to the clinic 7 to 14 days (visit 2) after dosing and again between 21 and 30 days (visit 3). Two subjects were excluded from cure rate calculations. Of the evaluable 28 patients, 24 (86%) were successfully treated (clinical cure) with a single dose of 2% clindamycin gel at visit 2. Of the ten patients evaluated for Nugent scoring, seven subjects were evaluable for bacteriologic cure. After a single dose of 2% clindamycin gel, four of seven (57%), and four of seven (57%) had a bacteriologic and therapeutic response, respectively. Of the 24 women who completed visit 2 and were cured based on Amsel criteria, 23 (96%) remained cured at visit 3. Of the subset of ten patients evaluated using Nugent scoring (bacteriologic evaluation), seven of nine (78%) had a score of 3 or less at visit 3. In this group, six of nine women were considered therapeutically cured (67%). There were no reports of adverse reactions, including local reactions to the vaginal gel product over the course of the study. These data support the expanded clinical evaluation of 2% clindamycin gel. |
| first_indexed | 2024-12-12T09:18:35Z |
| format | Article |
| id | doaj.art-fd81b4b89b944fe3867b2503ada6e09e |
| institution | Directory Open Access Journal |
| issn | 0390-6663 |
| language | English |
| last_indexed | 2024-12-12T09:18:35Z |
| publishDate | 2020-08-01 |
| publisher | IMR Press |
| record_format | Article |
| series | Clinical and Experimental Obstetrics & Gynecology |
| spelling | doaj.art-fd81b4b89b944fe3867b2503ada6e09e2022-12-22T00:29:18ZengIMR PressClinical and Experimental Obstetrics & Gynecology0390-66632020-08-0147451651810.31083/j.ceog.2020.04.5304S0390-6663(20)00301-2Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosisA. Dupre0H.H. Alur1D.R. Friend2OBGYN Associates of Montgomery, Montgomery, AL, United StatesTrilogic Pharma, Montgomery, AL, United StatesDaré Bioscience, Inc., San Diego, CA, United StatesThe objective of the study was to evaluate the efficacy and safety of a novel single 2% clindamycin phosphate vaginal gel for the treatment of bacterial vaginosis (BV). The vaginal gel, a thermosetting bioadhesive formulation containing 2% clindamycin phosphate, was studied in a single center, single arm, open-label study. Patients (n = 30) were screened for BV using the four Amsel criteria (visit 1). A subset of ten women were also assessed using Nugent scores. Eligible patients were consented and provided a single dose of 2.0% clindamycin phosphate gel in a prefilled vaginal applicator (5-gram total dose). Patients returned to the clinic 7 to 14 days (visit 2) after dosing and again between 21 and 30 days (visit 3). Two subjects were excluded from cure rate calculations. Of the evaluable 28 patients, 24 (86%) were successfully treated (clinical cure) with a single dose of 2% clindamycin gel at visit 2. Of the ten patients evaluated for Nugent scoring, seven subjects were evaluable for bacteriologic cure. After a single dose of 2% clindamycin gel, four of seven (57%), and four of seven (57%) had a bacteriologic and therapeutic response, respectively. Of the 24 women who completed visit 2 and were cured based on Amsel criteria, 23 (96%) remained cured at visit 3. Of the subset of ten patients evaluated using Nugent scoring (bacteriologic evaluation), seven of nine (78%) had a score of 3 or less at visit 3. In this group, six of nine women were considered therapeutically cured (67%). There were no reports of adverse reactions, including local reactions to the vaginal gel product over the course of the study. These data support the expanded clinical evaluation of 2% clindamycin gel.https://www.imrpress.com/journal/CEOG/47/4/10.31083/j.ceog.2020.04.5304bacterial vaginosisclindamycin phosphatevaginal gel |
| spellingShingle | A. Dupre H.H. Alur D.R. Friend Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis Clinical and Experimental Obstetrics & Gynecology bacterial vaginosis clindamycin phosphate vaginal gel |
| title | Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis |
| title_full | Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis |
| title_fullStr | Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis |
| title_full_unstemmed | Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis |
| title_short | Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis |
| title_sort | proof of concept study of a novel bioadhesive clindamycin phosphate 2 vaginal gel to treat bacterial vaginosis |
| topic | bacterial vaginosis clindamycin phosphate vaginal gel |
| url | https://www.imrpress.com/journal/CEOG/47/4/10.31083/j.ceog.2020.04.5304 |
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