title: The Efficacy and Safety of Eberconazole Nitrate 1% and Mometasone Furoate 0.1% w/w Cream in Subjects with Inflamed Cutaneous Mycoses.
abstract: BACKGROUND
  Topical antifungal agents along with the steroids may provide not only rapid symptomatic relief but also clearance of disease causing fungi in inflamed cutaneous mycoses (ICM).
  
  
  OBJECTIVE
  To assess the efficacy and safety of fixed dose combination (FDC) of Eberconazole nitrate 1% and Mometasone furoate 0.1% w/w cream, in subjects with ICM.
  
  
  METHODS
  This was a multi-centric, non-comparative study conducted in 155 eligible adult Indian subjects with ICM. They were treated with study medication for 21 days (D21) and followed up on day 35 (D35). Efficacy (by Investigator's Static Global Assessment-ISGA, symptom severity scores) and safety were assessed to evaluate the therapeutic response.
  
  
  RESULTS
  Of 155 subjects, 129 completed the study. Lesions healed completely in 77.52% and improved markedly in 22.48% patients by D21. There was a statistically significant reduction (p<0.001) in total symptom score (TSS) and mean severity scores of erythema, scaling and pruritus on days 7 and 21 compared to baseline. There was no treatment failure. Only 11 patients remained culture positive on D21 compared to 68 at baseline. Physicians evaluated the drug as 'Good' in 72% and 'Excellent' in 28% of subjects; adverse events were reported in 27.74% subjects and none was severe. There was a decrease in serum cortisol level in 4.52% (7/155) subjects and was considered clinically significant in three subjects. On D35, 18.55% and 24.20% subjects had greater ISGA score and TSS respectively, compared to D21.
  
  
  CONCLUSIONS
  Tested FDC demonstrated efficacy and was well tolerated by study population. It offers an effective and safe therapeutic option for the management of ICM.
authors.forename: Rao
authors.initials: R
authors.lastname: Gnaneshwar
authors.forename: A S
authors.initials: AS
authors.lastname: Kumar
authors.forename: Fernandes
authors.initials: F
authors.lastname: Carol
authors.forename: Jacintha
authors.initials: J
authors.lastname: Martis
authors.forename: H R
authors.initials: HR
authors.lastname: Jerajani
authors.forename: Maria
authors.initials: M
authors.lastname: Kuruvila
authors.affiliation: G 5, Mount Meru Apts, Road 5, Avenue 7, Banjara Hills, Hyderabad 500 034, India. lathasu@gmail.com.
authors.forename: M S
authors.initials: MS
authors.lastname: Latha
authors.forename: Binny
authors.initials: B
authors.lastname: Krishnankutty
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003508:Cycloheptanes / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000009:adverse effects*; D003881:Dermatomycoses / Q000188:drug therapy*; D004304:Dosage Forms; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003508:Cycloheptanes; D003879:Dermatologic Agents; D004304:Dosage Forms; D007093:Imidazoles; D000068656:Mometasone Furoate; C118963:eberconazole