OnychomycosisPhase 1NCT06485505
Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis
A Phase 1 study testing ISOtretinoin 10 MG, excimer light and Itraconazole 200 mg in people with Onychomycosis, run by Zagazig University at 1 site in Egypt.
Trial summary
3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- ISOtretinoin 10 MG, excimer light and Itraconazole 200 mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with onychomycosis
Who cannot join
- pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, Zagazig, 44519
mona Elradi, MD, +201067070550, monaelradi@medicine.zu.edu.eg
About this study
Official title: Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.
3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.
Read the detailed description
The sample size will be calculated by a statistician based upon the rate of onychomycosis cases attending at the outpatient clinical. 3 equal groups of patients will be included. inclusion criteria include: -definite diagnosis of dermatophyte onychomycosis using KOH examination and a fungal culture - a washout period of at least 1 month of any previous therapy -age> 16 years Exclusion criteria include: -pregnancy and lactation -Any active infection or inflammation in or around the nails other than onychomycosis -patients with liver diseases, heart disease and diabetes
Steps of performance and techniques used:
- Complete history taking.
- Detailed local examination:
Local examination will be done for the nail to detect swelling, induration, erythema around the nail, local pain and presence of pus during the sessions.
Patients with proven onychomycosis clinically, dermoscopically and through culture will be included in the study.
The included patients will sign an informed written consent before the beginning of the study, and the study will be done under the approval of the ethical committee for postgraduate studies and research of faculty of Medicine, Zagazig University.
Onychomycosis severity index (OSI) will be used for grading of onychomycosis severity where 0=no onychomycosis,1-5= mild onychomycosis,6- 15=moderate onychomycosis, and 16-35=severe onychomycosis.
The patients will be divided into 3 equal groups:
GROUP 1: (itraconazole group); all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects.
GROUP 2 : will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol.
Treatment protocol consists of low dose isotretinoin 20mg, every other day for a 3- month course. After completion of the course, treating dose of isotretinoin will be maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies will be permitted.
GROUP 3: will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device).
- Conditions
- Onychomycosis
- Being tested
- ISOtretinoin 10 MG, excimer light, Itraconazole 200 mg
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOtretinoin 10 MGDrug
Low dose isotretinoin as an adjuvant for itraconazole in treating onychomycosis
excimer lightDevice
excimer light as an adjuvant for itraconazole in treating onychomycosis
Itraconazole 200 mgDrug
Itraconazole alone
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Active comparator | all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects Receives: Drug: Itraconazole 200 mg |
| Itraconazole + Low dose Isotretinoin | Experimental | patients will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol. Treatment protocol consists of low dose isotretinoin (20mg, every other day for pediatrics) for a 3- month course. After completion of the course, treating dose of isotretinoin was maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies was permitted. Receives: Drug: ISOtretinoin 10 MG |
| Itraconazole +Excimer light | Experimental | will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device). Receives: Device: excimer light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
using onychomycosis severity index at baseline, last session and follow up vistis
Measured: 6 month frame: clinical assessment will be done at first presentation of the patients, monthly during the treatment course, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
Culture
Fungal culture to detect fungal cause and presence after treatment
Measured: 6 month frame: Fungal culture will be done at first presentation of the patients, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start12 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mona El Radi Kamal Mohamed Emam, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485505
- Sponsor's protocol ID
- Onychomycosis
- Status last verified
- Apr 2026
- First submitted
- 30 May 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06485505
- Acronym / sponsor ID
- Onychomycosis
- Conditions
- Onychomycosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- 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.
3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.
Detailed description
The sample size will be calculated by a statistician based upon the rate of onychomycosis cases attending at the outpatient clinical. 3 equal groups of patients will be included. inclusion criteria include: -definite diagnosis of dermatophyte onychomycosis using KOH examination and a fungal culture - a washout period of at least 1 month of any previous therapy -age> 16 years Exclusion criteria include: -pregnancy and lactation -Any active infection or inflammation in or around the nails other than onychomycosis -patients with liver diseases, heart disease and diabetes
Steps of performance and techniques used:
- Complete history taking.
- Detailed local examination:
Local examination will be done for the nail to detect swelling, induration, erythema around the nail, local pain and presence of pus during the sessions.
Patients with proven onychomycosis clinically, dermoscopically and through culture will be included in the study.
The included patients will sign an informed written consent before the beginning of the study, and the study will be done under the approval of the ethical committee for postgraduate studies and research of faculty of Medicine, Zagazig University.
Onychomycosis severity index (OSI) will be used for grading of onychomycosis severity where 0=no onychomycosis,1-5= mild onychomycosis,6- 15=moderate onychomycosis, and 16-35=severe onychomycosis.
The patients will be divided into 3 equal groups:
GROUP 1: (itraconazole group); all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects.
GROUP 2 : will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol.
Treatment protocol consists of low dose isotretinoin 20mg, every other day for a 3- month course. After completion of the course, treating dose of isotretinoin will be maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies will be permitted.
GROUP 3: will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | Active comparator | Drug: Itraconazole 200 mgall patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects |
| Itraconazole + Low dose Isotretinoin | Experimental | Drug: ISOtretinoin 10 MGpatients will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol. Treatment protocol consists of low dose isotretinoin (20mg, every other day for pediatrics) for a 3- month course. After completion of the course, treating dose of isotretinoin was maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies was permitted. |
| Itraconazole +Excimer light | Experimental | Device: excimer lightwill be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with onychomycosis
Key exclusion criteria (1 listed)
- pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.
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 |
|---|---|---|
| ISOtretinoin 10 MGLow dose isotretinoin as an adjuvant for itraconazole in treating onychomycosis | Drug | Itraconazole + Low dose Isotretinoin |
| excimer lightexcimer light as an adjuvant for itraconazole in treating onychomycosis | Device | Itraconazole +Excimer light |
| Itraconazole 200 mgItraconazole alone | Drug | Itraconazole |
Primary outcome
Clinical improvement
Time frame: 6 month frame: clinical assessment will be done at first presentation of the patients, monthly during the treatment course, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
using onychomycosis severity index at baseline, last session and follow up vistis
Culture
Time frame: 6 month frame: Fungal culture will be done at first presentation of the patients, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
Fungal culture to detect fungal cause and presence after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 ISOtretinoin 10 MG, excimer light and Itraconazole 200 mg in people with Onychomycosis, run by Zagazig University 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 6 month frame: clinical assessment will be done at first presentation of the patients, monthly during the treatment course, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.