Pediatric Subjects With Tinea Corporis

Tinea Corporis Clinical Trial

Official title:

A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227290
• Other study ID #: MUS90200_4024_1
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2014
• Last updated: October 27, 2016
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Corporis

Intervention

Drug:
• Naftin Cream

• Placebo Cream

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras,  Panama,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Success at Days 14 and 21	Defined as sign and symptom scores of 0 or 1	Day 14 and Day 21	Yes
Other	Clinical cure at Days 14 and 21	Defined as erythema, induration, and pruritus score of 0.	Days 14 and 21	Yes
Other	Subject Satisfaction	Assessment on 5 point scale or category of improvement from baseline.	Days 14 and 21	Yes
Other	Complete Cure	Defined as negative mycology and abscence of signs/symptoms.	Day 14	Yes
Other	Treatment of Effectiveness	Defined as negative KOH, negative culture, and signs/symptoms.	Day 14	Yes
Other	Mycology Cure	Defined as negative KOH result and negative dermatophyte culture.	Day 14	Yes
Primary	Primary Efficacy	Complete cure defined by negative KOH result and negative dermatophyte culture	Day 21	Yes
Secondary	Secondary Efficacy	Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.	Day 21	Yes