Non-inferiority Trial of Dapaconazole Versus Ketoconazole

NCT03320486 | Completed Phase 3

• 1 other identifier: GDN 018/16
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in a descriptive way, through the observation of the incidence of adverse events.

Conditions

Tinea Pedis

Keywords

Mycoses; Dermatomycoses; Antifugal Agents; Dapaconazole

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with therapeutic cure

  Proportion of participants, in each treatment group, who achieved therapeutic cure, defined as both clinical cure and mycological cure, on the assessment performed after 28 days of treatment. Clinical cure is defined as a score ≤ 2 for the sum of scores attributed to each sign or symptom (erythema, maceration/peeling, fissuring/cracking, itching and burning) as evaluated by a four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe). Mycological cure is defined as negative result for the direct mycological examination (potassium hydroxide \[KOH\] test) and a negative fungal culture.

  28 days of treatment

Secondary Outcomes (5)

• Proportion of participants with therapeutic cure

  42 days of treatment

• Proportion of participants maintaining therapeutic cure

  14 (±3) days after the end of treatment

• Proportion of participants maintaining therapeutic cure

  28 (±5) days after the end of treatment

• Number of days until clinical cure

  up to 42 days

• Number of adverse events per participant

  up to 80 (±5) days

Study Arms (2)

Group 1 - dapaconazole cream 2%

EXPERIMENTAL

Topical application of dapaconazole cream 2%, once daily, during 42 days.

Drug: Dapaconazole

Group 2 - ketoconazole cream 2%

ACTIVE COMPARATOR

Topical application of ketoconazole cream 2%, once daily, during 42 days.

Drug: Ketoconazole

Interventions

Dapaconazole DRUG

Application of 1 to 3 grams, depending on the lesion extension, per affected foot.

Also known as: Zilt

Group 1 - dapaconazole cream 2%

Ketoconazole DRUG

Application of 1 to 3 grams, depending on the lesion extension, per affected foot.

Also known as: Nizoral®

Group 2 - ketoconazole cream 2%

Eligibility Criteria

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

You may qualify if:

• Participants aged from 18 to 65 years old, male, or female with no childbearing potential or who are using an effective contraceptive method and who do not plan to become pregnant during the study period.
• Presence of dermatological lesion(s) of Tinea pedis, with a global clinical severity score ≥ 4, being a minimum score of 2 for itching or desquamation/maceration and a minimum score of 2 for erythema, having, also, the diagnosis confirmed by direct mycological (KOH) test.
• No previous treatment with antimycotic medication, in the last 2 months, for the current dermatologic lesion.
• No evidence of other significant diseases, that, at the investigator's discretion, may affect the participation in the clinical trial, in accordance with the protocol requirements.
• Ability to understand the nature and the objective of the clinical trial, including the risks and possible side effects; intention to cooperate with the investigator and act in accordance with the protocol requirements, as confirmed by the informed consent form signature.

You may not qualify if:

• Existing hepatic and/or renal diseases or other pathologic findings, which might interfere with the safety and tolerability of the active ingredients.
• Screening laboratory tests presenting deviations deemed as clinically significant, which, due to possible risks, prevents the participation in clinical trial.
• Known hypersensitivity to ketoconazole or to chemically related compounds (azoles) or to the compounds of the investigational products.
• Participants with severe or multiple drugs allergies, unless judged by the investigator as not clinically relevant to the participation in the clinical trial.
• Positive anti human immunodeficiency virus (anti-HIV) test, positive Hepatitis B Surface Antigen (HBs-Ag) test or positive anti hepatitis C virus (anti-HCV) test.
• Treatment, within 3 months prior to the start of the clinical trial treatment, with any drug known to have a well-established toxic potential to major organs.
• Pregnant or lactating women
• Presence of onychomycosis.
• Presence of "Moccasin type" Tinea pedis.
• Presence of infected Tinea pedis, or any other infection or pathology that may confuse the treatment evaluation.
• History of drug addiction.
• Diseases that may alter the immune system and, consequently, the host's response to the fungal presence (immunosuppressed participants), as well as the use of systemic immunosuppressive drugs, chemotherapy or radiotherapy, during the 3 months prior to the start of treatment.
• Use of drugs that may interfere with the assessment of the results, as well as use of topical immunosuppressants, topical antibiotics or topical corticosteroids, within 2 months prior to the start of treatment.
• Use of antipruriginous drugs, including antihistaminics, within 72 hours prior to the start of treatment.
• History of alcohol dependence and/or regular intake of alcoholic food or beverages containing ≥ 20 g of pure ethanol per day.

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Tinea Pedis; Mycoses; Dermatomycoses

Interventions

1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazole; Ketoconazole

Condition Hierarchy (Ancestors)

Tinea; 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

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gilberto De Nucci, MD

  Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: October 22, 2017
• First Posted: October 25, 2017
• Study Start: November 1, 2017
• Primary Completion: August 27, 2019
• Study Completion: November 12, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)