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Topic Oleozon in patients with epidermophytosis

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000289
Enrollment
300
Registered
2018-09-28
Start date
2018-11-05
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermophytosis

Interventions

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 - K
Ketoconazole
Anti-Infective Agents, Local
Oleozon
Terbinafina

Sponsors

National Center For Scientific Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

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

Countries

Cuba

Contacts

Public ContactJulio Fernandez Travieso

Clinical Trials Unit, National Center for Scientific Research

julio.fernandez@cnic.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026