Published Studies Related to Oravig (Miconazole)
Multicenter, double-blind, parallel group study investigating the non-inferiority
of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2%
ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp. 
the treatment of scalp seborrheic dermatitis... CONCLUSIONS: Miconazole shampoo is at least as effective and safe as ketoconazole
Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis. [2011.05]
Sertaconazole is a new antifungal agent. To compare the efficacy and tolerability of sertaconazole and miconazole cream in cutaneous dermatophytosis, this prospective, randomized, multicentric comparative, phase 4 study was undertaken in 260 patients with cutaneous dermatophytosis after approvals from Institutional Ethics Committees...
Miconazole oral gel increases exposure to oral oxycodone by inhibition of CYP2D6 and CYP3A4. [2011.03]
Our aim was to assess the effect of miconazole oral gel on the pharmacokinetics of oral oxycodone. In an open crossover study with two phases, 12 healthy volunteers took a single oral dose of 10 mg of immediate-release oxycodone with or without thrice-daily 85-mg miconazole oral gel treatment... Miconazole oral gel produces a rather strong inhibitory effect on CYP2D6, which deserves further study.
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.
Antimicrobial central venous catheters in oncology: efficacy of a rifampicin-miconazole-releasing catheter. [2010.04]
CONCLUSION: Immunocompromized patients suffering from cancer, transplantation, and dialysis patients with a long-term vascular access may mostly benefit from rifampicin-miconazole-releasing catheters.
Clinical Trials Related to Oravig (Miconazole)
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches [Not yet recruiting]
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
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
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women [Recruiting]
This research study is about vaginal infections such as bacterial vaginosis, yeast
infections, and trichomoniasis. Usually, these infections can be treated with medication,
but sometimes they come back after treatment. Researchers want to know if using vaginal
suppositories can decrease the risk of vaginal infections. Participants will include 234
women who are sexually active (greater than or equal to 4 episodes of sex with men during
the past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis
and/or vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory
testing at a screening visit. Women will receive vaginal suppositories containing drug or
inactive ingredients (placebo). Participation in the study will be about 12 months. Study
procedures include: urine and blood tests, physical exams, and questionnaires.
Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients [Recruiting]
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.
Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis [Recruiting]
This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects
with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study
which has a 2 week treatment period and a 4 week follow-up evaluation.
Clotrimazole Enemas for Pouchitis in Children and Adults [Recruiting]
Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients
with ulcerative colitis that is resistant to existing medical therapies. The development of
inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the
most common long-term complication of this procedure and can affect 50-60% of adults and
children. We have previously demonstrated that clotrimazole (delivered as a rectal
suppository) is generally safe, effective, and displays poor systemic absorption when used
in pediatric and adults with active pouchitis. We saw clinical benefit in patients with
pouch disease that had previously failed to respond to standard antibiotic, steroid, or
immunosuppressive therapies. The clinical trial outlined here will define the effectiveness
and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged
greater than two years) and adult patients with pouchitis.
Subjects in this study will be randomly assigned to receive either placebo (no active drug,
4 subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or
4000mg/day (8 subjects). No washout period is required, and subjects will be allowed to
continue their existing anti-inflammatory medications during their participation in the
study. Clotrimazole will be delivered nightly in the form of an enema. Subjects will
undergo flexible sigmoidoscopy (pouchoscopy) prior to and again after completing one month
of study therapy, and pouch disease activity will be graded at after each procedure using
the Pouchitis Disease Activity Index (PDAI). Clinical improvement will be defined as a drop
in PDAI score. If the drop in PDAI scores between placebo and either active clotrimazole
treatment group is not significant, and no subject experiences what are determined to be
study-related adverse effects, a second cohort of subjects will be recruited and studied
after receiving one month of either placebo (4 subjects), 6000 mg/day clotrimazole (8
subjects), or 7500mg/day clotrimazole (8 subjects).
Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole
blood levels will be measured during the first and last day of study participation. In
addition, adults will complete a health related quality of life assessment at baseline and
after completing study drug therapy.
All subjects will be eligible for one month of open-label study drug therapy after
completing one month of study drug therapy.