Foot Infection Tinea PedisPhase 1NCT02882438
Glucosamine Sulphate and Ginkgo Biloba as Antifungal Activity for Treating Tinea Pedis
A Phase 1 study testing infected group in people with Foot Infection Tinea Pedis, run by Ahmed A. H. Abdellatif at 1 site in Egypt.
Trial summary
Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a fungal infection of the feet and it is easily spread. Oral therapy is usually used for chronic conditions or when topical treatment has failed. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Infection Tinea Pedis
- What is being tested?
- infected group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- It is important to follow up and collect data, preferably for six months for local and systemic activity of Ginkgo Biloba and Glucosamine, to establish whether the infection recurrent or not.
Who cannot join
- Larger numbers of participants having different kind of fungal infection are needed to test efficiency drug in order to produce more reliable data.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Clinic
Asyut, 71526
Ahmed AH Abdellatif, PhD
About this study
Official title: Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis
Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a fungal infection of the feet and it is easily spread. Oral therapy is usually used for chronic conditions or when topical treatment has failed. The aim of this study is to prove the antifungal and antibacterial activity of Ginko Biloba (GKB) \& Glucosamine (GL) as separate material or both in combination.
Read the detailed description
Ginko Biloba (GKB) \& Glucosamine (GL) were formulated in different dosage forms such as capsules, hydrogel and spray. GKB\&GL were in filled in hard gelatin capsules as three formulae (GKB caps, GL caps and both as mixture in caps). Also, GKB\&GL were formulated in hydrogel using 2% carbopol 934 as three formulae (GKB only, GL only and both as mixture). The same also were formulated as spray using alcohol, water and glycerol in concentration of 60%, 20% and 20% respectively. The study included 5 trials, involving 35 participants. The oral formulae were tried on 30 participants having Tenia Pedis. Fluconazole was as standard antifungal drug.The antifungal activity of all gel formulae was determined by Agar well-diffusion method. It is also important to follow up and collect data, preferably for six months for local and systemic activity, to establish whether or not the infection recurred or not. In future clinical trials, research should consider the costs of the different treatment approaches.
- Conditions
- Foot Infection Tinea Pedis
- Being tested
- infected group, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infected groupDrug
Also called Body Spray
Ginkgo Biloba in different dosage forms
control groupDrug
Also called placebo
placebo without Ginkgo Biloba
| Study group | Role | What they receive |
|---|---|---|
| Infected group | Active comparator | A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms. Receives: Drug: infected group |
| Control group | Placebo comparator | A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba. Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the antifungal activity of Ginkgo Biloba & Glucosamine
Ginkgo Biloba and Glucosamine will be applied with infected patients even systemically or topically. The results will be compared with control groups to prove the Antifungal Activity.
Measured: six months
Secondary outcomes (1)
Stability test for different dosage forms
Stability test will be studied for dosage forms. The test will carried out by standing the products on shelf life for three months. The stability test will be recorded using high performance liquid chromatography each thee days.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2020 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot Infection Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed A. H. Abdellatif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed A. H. Abdellatif, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882438
- Sponsor's protocol ID
- AlAzharGGATP
- Status last verified
- Oct 2019
- First submitted
- 26 Nov 2015
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tauber A, Muller-Goymann CC. In vitro model of infected stratum corneum for the efficacy evaluation of poloxamer 407-based formulations of ciclopirox olamine against Trichophyton rubrum as well as differential scanning calorimetry and stability studies. Int J Pharm. 2015 Oct 15;494(1):304-11. doi: 10.1016/j.ijpharm.2015.08.023. Epub 2015 Aug 11.
PubMed 26276254
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis
- ClinicalTrials.gov ID
- NCT02882438
- Acronym / sponsor ID
- AlAzharGGATP
- Conditions
- Foot Infection Tinea Pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahmed A. H. AbdellatifUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a fungal infection of the feet and it is easily spread. Oral therapy is usually used for chronic conditions or when topical treatment has failed. The aim of this study is to prove the antifungal and antibacterial activity of Ginko Biloba (GKB) \& Glucosamine (GL) as separate material or both in combination.
Detailed description
Ginko Biloba (GKB) \& Glucosamine (GL) were formulated in different dosage forms such as capsules, hydrogel and spray. GKB\&GL were in filled in hard gelatin capsules as three formulae (GKB caps, GL caps and both as mixture in caps). Also, GKB\&GL were formulated in hydrogel using 2% carbopol 934 as three formulae (GKB only, GL only and both as mixture). The same also were formulated as spray using alcohol, water and glycerol in concentration of 60%, 20% and 20% respectively. The study included 5 trials, involving 35 participants. The oral formulae were tried on 30 participants having Tenia Pedis. Fluconazole was as standard antifungal drug.The antifungal activity of all gel formulae was determined by Agar well-diffusion method. It is also important to follow up and collect data, preferably for six months for local and systemic activity, to establish whether or not the infection recurred or not. In future clinical trials, research should consider the costs of the different treatment approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected group | Active comparator | Drug: infected groupA group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms. |
| Control group | Placebo comparator | Drug: control groupA group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- It is important to follow up and collect data, preferably for six months for local and systemic activity of Ginkgo Biloba and Glucosamine, to establish whether the infection recurrent or not.
Key exclusion criteria (1 listed)
- Larger numbers of participants having different kind of fungal infection are needed to test efficiency drug in order to produce more reliable data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infected groupAlso: Body SprayGinkgo Biloba in different dosage forms | Drug | Infected group |
| control groupAlso: placeboplacebo without Ginkgo Biloba | Drug | Control group |
Primary outcome
Assessment the antifungal activity of Ginkgo Biloba & Glucosamine
Time frame: six months
Ginkgo Biloba and Glucosamine will be applied with infected patients even systemically or topically. The results will be compared with control groups to prove the Antifungal Activity.
1 secondary outcome
Stability test for different dosage forms
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Results publication: PubMed 26276254Tauber A, Muller-Goymann CC. In vitro model of infected stratum corneum for the efficacy evaluation of poloxamer 407-based formulations of ciclopirox olamine against Trichophyton rubrum as well as differential scanning calorimetry and stability studies. Int J Pharm. 2015 Oct 15;494(1):304-11. doi: 10.1016/j.ijpharm.2015.08.023. Epub 2015 Aug 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing infected group in people with Foot Infection Tinea Pedis, run by Ahmed A. H. Abdellatif at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A. H. Abdellatif, phD (+201016660069, ahmed.a.h.abdellatif@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the antifungal activity of Ginkgo Biloba & Glucosamine (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.