Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

Tinea Pedis Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335255
• Other study ID #: NFTC 1409-1722
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2014
• Est. completion date: May 15, 2018

Study information

• Verified date: September 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%

Description:

The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1519
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant, non-lactating females 18 years of age or older.

• The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus.

• Clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.

• The presence of interdigital tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.

Exclusion Criteria:

• Females who are pregnant, lactating or planning to become pregnant during the study period.

• Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.

• Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.

• Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.

• Use of oral Terbinafine or Itraconazole within 2 months prior to baseline visit.

• Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.

• Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation.

• Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

• History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place patient at undue risk by participation or could jeopardize the integrity of the study evaluations.

• Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the investigator's evaluation of tinea pedis.

• Patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Naftifine Hydrochloride Gel 2%
Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
• Naftin® Gel 2%
Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
• Placebo Topical Gel
Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic cure after end of treatment	The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).	Study day 38-46