CLINDESSE SUMMARY
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.
Clindesse™ is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women. There are no adequate and well-controlled studies of Clindesse™ in pregnant women.
Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
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NEWS HIGHLIGHTSMedia Articles Related to Clindesse (Clindamycin Vaginal)
Birth Control May Help Ward Off Bacterial Vaginosis
Source: MedicineNet Bacterial Vaginosis Specialty [2009.07.31]
Title: Birth Control May Help Ward Off Bacterial Vaginosis
Category: Health News
Created: 7/31/2009 7:00:00 AM
Last Editorial Review: 7/31/2009
Bacterial Vaginosis
Source: MedicineNet Chlamydia In Women Specialty [2009.02.18]
Title: Bacterial Vaginosis
Category: Diseases and Conditions
Created: 11/7/2001 1:44:00 PM
Last Editorial Review: 2/18/2009
What is Bacterial Vaginosis?
Source: MedicineNet metronidazole cream Specialty [2007.07.11]
Title: What is Bacterial Vaginosis?
Category: Doctor's Views
Created: 5/2/2005
Last Editorial Review: 7/11/2007
Published Studies Related to Clindesse (Clindamycin Vaginal)
Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel in moderate or severe acne subpopulations. [2009.08]
BACKGROUND: Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. OBJECTIVE: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations... CONCLUSION: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.
An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efficacy and safety in 2813 patients. [2008.11]
OBJECTIVE: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris... CONCLUSIONS: Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.
Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study. [2008.01.15]
BACKGROUND: The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure... CONCLUSION: The study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment, but for women initially cured, adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up. TRIAL REGISTRATION NUMBER: ISRCTN62879834.
The efficacy and safety of a single dose of polyhexamethylene biguanide gynaecologic solution versus a seven-dose regimen of vaginal clindamycin cream in patients with bacterial vaginosis. [2008.01]
OBJECTIVE: At the present the clinical treatment of choice of bacterial vaginosis (BV) is the use of systemic or local metronidazole or clindamycin. Aim of the study was to evaluate the efficacy and tolerability of a single dose of gynaecologic solution, Polyhexamethylene Biguanide (PHMB), Monogin, in the treatment of BV in comparison to a 7-days treatment with clindamycin vaginal cream... CONCLUSIONS: A single dose, of PHMB gynaecologic solution (Monogin) is equivalent in safety and efficacy to a 7-dose regimen of Clindamycin vaginal cream in the treatment of bacterial vaginosis. Futhermore the compliance as been reported to be higher for the single-dose treatment with PHMB than with 7-days treatment with Clindamycin.
The effects of intravaginal clindamycin and metronidazole therapy on vaginal mobiluncus morphotypes in patients with bacterial vaginosis. [2007.04]
OBJECTIVE: The objective of this study was to compare the effects of treatments for bacterial vaginosis (BV) on vaginal Mobiluncus morphotypes... CONCLUSION: Clindamycin reduces vaginal Mobiluncus morphotypes to a greater extent than metronidazole in patients with BV; this correlates with a higher BV cure rate.
Clinical Trials Related to Clindesse (Clindamycin Vaginal)
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne [Recruiting]
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative
for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a
combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you have acne vulgaris on your face.
Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,
legs, and back.
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne [Recruiting]
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy
of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne [Recruiting]
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the
study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin
and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face
fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After
visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the
entire face for an additional 6 weeks.
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea [Recruiting]
The purpose of this study is to determine whether Clindamycin Phosphate 1. 2% And Tretinoin
0. 025% Gel are effective and safe in the treatment of papulopustular rosacea.
Comparison of Cephalexin Versus Clindamycin for Empiric Treatment of Suspected CA-MRSA Skin Infections [Recruiting]
The purpose of this study is to help define the role of antibiotics in the treatment of
pediatric skin infections caused by CA-MRSA. We hypothesize that treatment with cephalexin,
a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not
result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is
most often susceptible.
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