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

Information source: Merz Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tinea Cruris; Jock Itch

Intervention: Naftin 1% Cream (Drug); Placebo Cream (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merz Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Stefan Plaum, MD, Study Director, Affiliation: Merz Pharmaceuticals, LLC

Summary

To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.

Clinical Details

Official 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

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

Primary outcome: 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).

Secondary outcome: 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).

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Merz Investigational Site # 501001, Belize City, Belize

Merz Investigational Site # 501002, Belize City, Belize

Merz Investigative Site # 180002, San Cristobal, Dominican Republic

Merz Investigative Site # 180001, Santo Domingo, Dominican Republic

Merz Investigative Site # 504001, San Pedro Sula, Honduras

Additional Information

Starting date: August 2013
Last updated: March 26, 2015

Page last updated: August 23, 2015

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