Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01885156
• Date of registration: 20/06/2013
• Prospective Registration: Yes
• Primary sponsor: Merz Pharmaceuticals, LLC
• Public title: Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
• Scientific title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
• Date of first enrolment: August 2013
• Target sample size: 65
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01885156
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belize, Dominican Republic, Honduras

Contacts

• Name: Stefan Plaum, MD
• Affiliation: Merz Pharmaceuticals, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Review and sign statement of Informed Consent and HIPAA authorization.

- Males or non-pregnant females = 12 years of age to 17 years, 11 months, of any race
or sex. Females of child-bearing potential must have a negative urine pregnancy test.

- The parent/legal guardian must complete the informed consent process AND the subject
must complete the assent process and sign the appropriate form (if age appropriate).

- Presence of tinea cruris characterized by clinical evidence of a tinea infection (at
least moderate erythema, moderate scaling, and mild pruritus) based on signs and
symptoms.

- KOH positive baseline skin scrapings obtained from the site most severely affected or
a representative site of the overall severity.

- Subjects must be in good health and free from any clinically significant disease that
might interfere with the study evaluations.

- Subject must be able to understand the requirements of the study and willing to
comply with the study requirements.

Exclusion Criteria:

- A life threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable
angina, or myocardial infarction) 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.- Severe dermatophytoses, mucocutaneous
candidiasis, or bacterial skin infection.

- Subjects with a known hypersensitivity 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.

- Atopic or contact dermatitis.

- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.

- Female subject who is pregnant or lactating, who is not using or does not agree to
use an acceptable form of contraception during the study, or who intends to become
pregnant during the study (females who are surgically sterilized for at least 2
years are not considered to be of childbearing potential).

- Subjects using the following medications:

- Topical anti-fungal therapy, powders or topical corticosteroids applied
within 14 days prior to randomization. Terbinafine, butenafine, and naftifine
(topical) within 30 days prior to randomization.

- Oral anti-fungal therapies within 3 months of randomization (8 months for oral
terbinafine).

- Systemic antibiotic or corticosteroid treatment within 30 days of randomization.

- Any other significant treatments, except hormonal contraception and
multivitamin, at the discretion of the investigator that would interfere with
study treatment.



Age minimum: 12 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Jock Itch

Tinea Cruris

Intervention(s)

Drug: Naftin 1% Cream

Drug: Placebo Cream

Primary Outcome(s)

Safety of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). [Time Frame: Week 6]

Secondary Outcome(s)

Efficacy of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH and culture positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). [Time Frame: Week 6]

Secondary ID(s)

MUS 90200_3028_1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors