Topic Oleozon in patients with epidermophytosis

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

OLEO-KETO-TERBI

Scientific title:

Comparative study of the efficacy and safety of topic OLEOZON, Ketoconazole and Terbinafine in patients with epidermophytosis.

Secondary indentifying numbers:

OLEOZON-COMPARATIVE-02

Issuing authority of the secondary identifying numbers:

National Center For Scientific Research

Source(s) of monetary or material support:

CNIC-BIOCUBAFARMA

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Lazara

Midle name:

Alacan

Last name:

Perez

Medical Specialty :

Specialist 2nd Degree in Dermatology

Affiliation:

"Commander Manuel Fajardo" Clinical-Surgical Hospital

Postal address:

D street /29 and Zapata, Vedado, Revolution square

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78323918

+53-53582081

Email address:

lazara.alacan@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Carlos J Finlay Military Hospital, Marlenys Perez Bruzon MD, Specialist 2do Degree in Dermatology

Research ethics committees:

"Commander Manuel Fajardo" Clinical-Surgical Hospital, May 2th, 2018

"Carlos J Finlay" Military Hospital, February 1th, 2018

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

05/11/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Epidermophytosis

Health condition(s) code:

Tinea

Dermatomycoses

Mycoses

Skin Diseases, Infectious

Skin Diseases

Skin and Connective Tissue Diseases

Bacterial Infections and Mycoses

Infection

Intervention(s):

Group 1 - Oleozon (experimental): Oleozon® topical in brushstrokes. It will use by topical route, twice a day (in the morning when getting up and after bath in the afternoon) for 6 weeks. Group 2 - Ketoconazole (control): Ketoconazole 2% cream. It will use by topical route, twice a day (in the morning when getting up and after bath in the afternoon) for 6 weeks. Group 3 - Terbinafine (control): Terbinafine at 1% cream. It will use by topical route, twice a day (in the morning when getting up and after bath in the afternoon) for 6 weeks.

Intervention code:

Ketoconazole

Antifungal Agents

Anti-Infective Agents, Local

Administration, Topical

Intervention keyword:

Oleozon; Terbinafina

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Clinical cure (Absence of skin lesions in the lower limbs characteristic of these conditions). Measurement time: Week, 2, 4 and, 6 of treatment. Mycological Healing (Negativization of the microbiological examination). Measurement time: Sixth week of treatment. Clinical and Mycological Healing (Yes when Clinical cure and Mycological Healing exists, No in other case). Measurement time: Sixth week of treatment.

Key secondary outcomes:

Treatment time to achieve healing (It will measure in weeks).Measurement time: Weeks 2, 4 and 6 of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

Patients greater than or equal to 18 years, of both sexes, who have signed their informed consent to participate in the study, with clinical diagnosis and positive mycological diagnosis of tinea pedis variety squamous, in addition patients without other infection added, virgin of treatments or with more than five days without treatment Specific topical or systemic.

Exclusion criteria:

Decompensated diabetes mellitus (fasting glucose> 7 mmol/L), diagnosed neoplasms, severe septic states, history of liver failure, history of renal failure, chronic diseases, pregnancy, concomitant use of corticosteroids, cytostatics or immunosuppressants and antibiotics, clinical history usual allergy to medications or any other special condition that at the discretion of the doctor puts your health and life at risk during the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

300

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Doctor in Pharmaceutical Sciences

Affiliation:

Clinical Trials Unit, National Center for Scientific Research

Postal Address:

25 Avenue and 158 Street, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085834

Email :

julio.fernandez@cnic.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Doctor in Pharmaceutical Sciences

Affiliation:

Clinical Trials Unit, National Center for Scientific Research

Postal Address:

25 Avenue and 158 Street, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085834

Email :

julio.fernandez@cnic.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000289

Date of Registration in Primary Registry:

28/09/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [3]