CLOTRIMAZOLE SUMMARY
Clotrimazole cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.
Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur.
Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum,Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.
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NEWS HIGHLIGHTS
Published Studies Related to Clotrimazole (Clotrimazole Topical)
Treatment of scabies: the topical ivermectin vs. permethrin 2.5% cream. [2013] Human scabies is caused by an infestation of the skin by the human itch mite
(Sarcoptes scabiei va.After repeating the treatment, ivermectin was as effective as
permethrin 2.5% cream at the 4-week follow up.
Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial. [2010.08] This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007...
Randomized, comparative, double-blind, double-dummy, multicenter trial of miconazole buccal tablet and clotrimazole troches for the treatment of oropharyngeal candidiasis: study of miconazole Lauriad(R) efficacy and safety (SMiLES). [2010.07] BACKGROUND: Oropharyngeal candidiasis (OPC) is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Once-daily miconazole 50 mg buccal tablet (MBT) is a novel delivery system using an extended-spectrum azole with potent in vitro activity against many Candida species, including some that may be resistant to other azoles... CONCLUSIONS: In this large trial, once-daily MBT was shown to be noninferior to CT 5 times daily in the treatment of OPC in HIV-positive patients. MBT offers an effective, safe, and well-tolerated topical treatment option for OPC administered as a convenient once-daily dose.
Randomized, comparative, double-blind, double-dummy, multicenter trial of
miconazole buccal tablet and clotrimazole troches for the treatment of
oropharyngeal candidiasis: study of miconazole Lauriad® efficacy and safety
(SMiLES). [2010] species, including some that may be resistant to other azoles... CONCLUSIONS: In this large trial, once-daily MBT was shown to be noninferior to
Single-dose oral fluconazole versus topical clotrimazole in patients with
pityriasis versicolor: A double-blind randomized controlled trial. [2010] This study was designed to compare the therapeutic effects of topical
clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind
randomized controlled trial was carried out in the dermatological clinic of
Gorgan, northern Iran, between April 2006 and May 2007...
Clinical Trials Related to Clotrimazole (Clotrimazole Topical)
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches [Completed]
Background: Oral candidiasis is most frequently found among the elderly .It is accompanied
with oral pain, irritation, burning sensation. In addition, the altered taste sensation may
cause nutrition compromise, which may affect ones diet. Management of superficial oral
Candida is usually achieved by treatment with clotrimazole, a fungi static drug which is
given five times per day with instruction to slowly suck on it with out the dentures.
Working hypothesis and aims: Management of oral candidiasis is feasible. The major
disadvantage of the mode of action now days is the substantively of the drug in the oral
cavity and patient compliance. A sustained release varnish which is easily applied on the
dentures, which also release the anti fungal drug for at least a day, may overcome some of
the pit falls of the treatment applied today.
Based on our past experience, in developing local sustained release varnishes for dental
use, we anticipate that we can also formulate a special anti fungal sustained release
varnish which will fit the special and unique needs of the elderly population.
Methods: Sustained release varnish will be developed in our laboratory. The kinetics of
release (using HPLC) and antifungal activity (Bioassays) will be examined in vitro. The
formulation showing the optimal results will be tested on human subjects with oral
candidiasis. The efficacy of the varnish will be examined clinically (reduction in
symptoms), microbiology (reduction of oral fungal), pharmaceutically (release kinetics in
vivo).
Expected results: The clinical out come of one time varnish application will be improved
compared to the five times application of lozenges (used today). The severity of the
disease should decrease and the healing period should be shorten drastically.
Importance: This is a novel pharmaceutical development of a local application of a dental
varnish designed specially to the elderly population
Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients [Completed]
Otomycosis is a superficial fungal infection of the external ear canal. Patients should be
treated with cleaning fungal debris combined with topical antifungal agent. There is wide
range of topical antifungal agents. However, there is still no consensus of the most
effective topical antifungal agents in treatment otomycosis is still lacking.
According to Thai National List of essential medicines for topical antifugal agents are:
- acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)
- boric acid (3% in isopropyl alcohol)
- gentian violet
- clotrimazole ear drop. But from literature review, there is no comparative study
between boric acid and clotrimazole solution before.
Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole
solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.
Comparative Efficacy of Ovule vs Tablet [Completed]
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not
inferior to the old Canesten formulation (tablet)
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections [Completed]
Randomized, Parallel Group, Active Controlled Trial to compare effectiveness and
tolerability of 2 different vaginal formulations containing 200mg clotrimazole and
clindamycin phosphate equivalent to 100mg clindamycin for 3 days in women clinically
diagnosed to have infective vaginitis.
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis [Recruiting]
Reports of Suspected Clotrimazole (Clotrimazole Topical) Side Effects
Vaginal Haemorrhage (80),
Candidiasis (14),
Vaginal Discharge (11),
Maternal Exposure During Pregnancy (10),
Genital Haemorrhage (8),
Abdominal Discomfort (8),
Kidney Malformation (8),
Haemorrhage (7),
Vaginal Disorder (7),
Ovarian Cyst (7), more >>
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Page last updated: 2014-11-30
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