Pediatric Subjects With Tinea Corporis

Completed · Phase 4 · Has a placebo group

Conditions studied: Tinea Corporis

In brief

The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.

Key facts

Study ID

NCT02227290

Run by

Merz North America, Inc.

People needed

230

Starts

2014-08-01

Expected to finish

2015-12-01

Last updated by the study team

2016-10-28

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
• Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
• KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.

You may not qualify if…

• Tinea infection of the face, scalp, groin, and/or feet
• A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
• Subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results
• Subjects with a known hypersensitivity or other contradictions to study medications or their components.
• Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
• Uncontrolled diabetes mellitus.
• Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
• Current diagnosis of immunocompromising conditions.
• Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
• Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
• Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.

Where it is running

• Merz Investigative Site#001316 — Tucson, Arizona, United States
• Investigative Site# 0010320 — Encino, California, United States
• Merz Investigative Site#001313 — Fremont, California, United States
• Merz Investigative Site#001301 — San Diego, California, United States
• Merz Investigative Site#001312 — Miami, Florida, United States
• Merz Investigative Site#001311 — Miami, Florida, United States
• Merz Investigative Site #001310 — Miramar, Florida, United States
• Merz Investigative Site#001307 — Saint Joseph, Missouri, United States
• Merz Investigative Site#001309 — Omaha, Nebraska, United States
• Merz Investigative Site#001314 — Henderson, Nevada, United States
• Merz Investigative Site#001126 — Raleigh, North Carolina, United States
• Merz Investigative Site#001293 — Winston-Salem, North Carolina, United States
• Investigative Site# 0010319 — Gresham, Oregon, United States
• Merz Investigative Site#001097 — Nashville, Tennessee, United States
• Merz Investigative Site#180002 — San Cristobal, Dominican Republic
• Merz Investigative Site# 180001 — Santo Domingo, Dominican Republic
• Merz Investigative Site#504001 — San Pedro Sula, Honduras
• Merz Investigative Site#507001 — Panama City, Panama
• Merz Investigative Site#001279 — Cidra, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.