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

NCT02335255 | Completed Phase 1

• 1 other identifier: NFTC 1409-1722
• Study Type: interventional
• Target: 1,519
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Naftifine Hydrochloride Gel 2%

EXPERIMENTAL

Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)

Drug: Naftifine Hydrochloride Gel 2%

Naftin® Gel 2%

ACTIVE COMPARATOR

Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)

Drug: Naftin® Gel 2%

Placebo Topical Gel

PLACEBO COMPARATOR

Placebo Topical Gel (Taro Pharmaceuticals Inc.)

Drug: Placebo Topical Gel

Interventions

Naftifine Hydrochloride Gel 2% DRUG

Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Also known as: Naftifine

Naftifine Hydrochloride Gel 2%

Naftin® Gel 2% DRUG

Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Also known as: Naftifine

Naftin® Gel 2%

Placebo Topical Gel DRUG

Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Also known as: Vehicle

Placebo Topical Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Tinea Pedis

Interventions

naftifine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 9, 2015
• Study Start: June 27, 2014
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share