Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel

NCT03823040 | Completed Phase 1 DMC

• 1 other identifier: OXIHebaSLNs
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical study for the developed oxiconazole nitrate solid lipid nanoparticles (SLNs) gel system compared to the corresponding marketed product was conducted on 28 patients with different types of tinea fungal infection.

Conditions

Tinea

Outcome Measures

Primary Outcomes (1)

• Measurement of clinical improvement using quartile grading scale patient satisfaction

  the clinical improvement of the patients was assessed according to quartile grading scale patient satisfaction. It was rated by the patient and the physician as excellent, good, fair and poor according to the following criteria. Excellent: both the patient and the physician agreed that the result was satisfactory. Good: the result although acceptable was not quite up to expectation of the patient, but the physicians were pleased with the outcome. Fair: the improvement was evaluated by both the patient and the physician to be less than expected but still with same improvement. Poor: unsatisfactory results to the patient and /or the physician. All adverse effects were checked during study.

  one month

Secondary Outcomes (1)

• Microscopical examination of skin scrapes for detection of fungal elements

  one month

Study Arms (2)

Tinox® group

ACTIVE COMPARATOR

Male patients (12 to 43 years old) including 5 cases tinea pedis, 9 tinea versicolor and treated with oxiconazole nitrate cream 1%.

Drug: Oxiconazole Nitrate Cream 1%

Oxiconazole nitrate SLNs loaded gel group

EXPERIMENTAL

13 males and one female (17 to 50 years old) including 3 cases tinea pedis, 8 tinea versicolor, 3 tinea circinate and treated with oxiconazole nitrate SLNs loaded gel

Drug: Oxiconazole nitrate SLNs loaded gel.

Interventions

Oxiconazole Nitrate Cream 1% DRUG

Tinox® group was treated with oxiconazole nitrate cream 1 % . Treatment was performed by rubbing the cream twice daily for two/ four weeks according to different types of tinea.

Also known as: Tinox® cream 1 %

Tinox® group

Oxiconazole nitrate SLNs loaded gel. DRUG

Oxiconazole nitrate SLNs loaded gel group was treated with oxiconazole nitrate SLNs loaded gel.Treatment was performed by rubbing the gel twice daily for two/ four weeks according to different types of tinea.

Also known as: Developed SLNs gel

Oxiconazole nitrate SLNs loaded gel group

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with different types of tine infection

You may not qualify if:

• Pregnant females and patients with Immunocompromising disease, open wounds and psychological disorders were excluded.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital,dermatology department, out patient clinic

Minya, 61519, Egypt

Location

MeSH Terms

Conditions

Tinea

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Heba F Mansour, Ph.D

  Associate professor of Pharmaceutics, Faculty of Pharmacy, Minia and Deray University, Minia, Egypt.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pharmaceutics, Faculty of Pharmacy, Minia University

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 30, 2019
• Study Start: July 16, 2018
• Primary Completion: December 23, 2018
• Study Completion: December 30, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

EG (1)