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Topic Oleozon in patients with epidermophytosis
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28 September 2018 - 1:22pm
by Gladys
19 July 2023 - 3:46pm
by Gladys
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Revision of 19 July 2023 - 3:46pm:
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
Primary sponsor:
National Center For Scientific Research
Secondary sponsor:
Not applicable
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
Country:
Cuba
Zip Code:
10600
Telephone:
+53-78323918
+53-53582081
Email address:
lazara.alacan@infomed.sld.cu
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:
3
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
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72085834
Email :
julio.fernandez@cnic.cu
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
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72085834
Email :
julio.fernandez@cnic.cu
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
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