A double-blind, randomized, parallel group comparison of Nizoral® cream (F012), ketoconazole 2% cream (F126) and placebo (F000) in the treatment of interdigital Tinea Pedis. - Ketoconazole cream formulations in Tinea pedis

Phase 1

• Conditions: For the treatment of tinea pedis

• Registration Number: EUCTR2006-006513-33-GB
• Lead Sponsor: Janssen Pharmaceutica NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-09
• Study Completion: 2008-10-14
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female subjects aged 18 years or more.
2.Subjects must be co-operative, reliable and sufficiently competent to grade and record symptoms as requested.
3.Clinical diagnosis of uncomplicated interdigital Tinea pedis confirmed by KOH microscopy.
4.Female subjects must be, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at screening.
5.Willing to adhere to the prohibitions and restrictions specified in this protocol.
6.Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Complicated Tinea pedis defined as: Confluent, diffuse moccasin type tinea pedis of the entire plantar surface, onychomycosis; other dermatomycosis requiring active treatment.
2.Subjects with a previous sensitivity to imidazole antifungal agents or to any ingredient of the study medication.
3.History of disallowed therapies: history of oral antifungal treatments within the previous 6 weeks; recent use (within two weeks of the study start) of topical antifungal agent; immunosuppressive or radiation therapy within the previous four weeks; recent use (within two weeks prior to screening) of other oral antibiotics, systemic corticosteroids or topical corticosteroids or antibiotics applied to the feet.
4.Recent history of drug or alcohol abuse, psychosis, or other condition making the subject unlikely to comply with the protocol.
5.Known HIV-positive (testing will not be performed).
6.Uncontrolled diabetes mellitus or peripheral vascular disease requiring active treatment.
7.Clinically relevant abnormal findings on clinical examination of the feet.
8.Any subject in whom skin scraping would be considered contraindicated.
9.Have received an experimental drug or used an experimental medical device within 30 days prior to the study or within five half-lives of the investigational drug, whichever is longer.
10.Is pregnant or breast-feeding.
11.Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified