Oral Potentially Malignant LesionsPhase 1/2NCT06271564
Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions
A Phase 1/2 study testing Magnetite ZnO Composite Nanoparticles in people with Oral Potentially Malignant Lesions, run by Ain Shams University at 1 site in Egypt.
Trial summary
ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Oral Potentially Malignant Lesions
- What is being tested?
- Magnetite ZnO Composite Nanoparticles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Feb 2024to 2 Apr 2026
- Phase
- Phase 1/2
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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders ranged from 25 to 60 years.
- Clinically confirmed OPMLs: the clinical picture of oral erythroplakia includes well-demarcated red discs with a smooth or granular surface, leukoplakia is classified into four clinical types: type I, a flat white patch or plaque without red components; type II, a flat white patch or plaque with red components; type III, a slightly raised or elevated white plaque; and type IV, a markedly raised or elevated white plaque.
- Histopathological confirmed OPMLs with low or moderate dysplasia
Who cannot join
- Presence of systemic conditions as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using a medical questionnaire guided by Cornell Medical Index
- Smoking 6 weeks before the clinical trial
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history.
- Pregnancy or breastfeeding.
- Histological diagnosis of severe, or invasive oral squamous cell carcinoma.
- Vulnerable groups (Handicapped, orphans or prisoners).
- Any lesion less than 1 cm in diameter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions (A Randomized Controlled Clinical Trial)
ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. They can be further surface engineered to show increased selective cytotoxicity. The synthesis process of ZnO nanoparticles is relatively easy, with a wide variety of methods. Owing to these different methods of synthesis, their size and size distribution can be easily controlled. One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite Nanoparticles.Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell.
Read the detailed description
Two interventions will be used; Magnetite ZnO-Fe3O4 Composite NPs extract and Placebo gel in custom made inert hydrophilic adhesive gel paste will be prepared in Nanotechnology engineering service in Egypt (Nano Gate), to enhance the adhesiveness of the two study interventions to oral mucosa.Group I (Test Group): Will include 15 patients with OPLs that will be treated with 5% topical ZnO-Fe3O4 Magnetic Composite NPs gel applied 3 times per day33 for 6 weeks9.
Group II (Positive Control Group):
Will include 15 patients with oral lichen planus lesions that will be treated with Topical Placebo Gel applied 3 times per day for 6 weeks.
The whole study period will be 18 weeks; 6 weeks as an active treatment period starting 1 week after the biopsy is taken then treatment discontinued for all groups and patients will be followed up for another 12 weeks in a treatment-free period.IV-Treatment efficacy evaluation A) Clinical efficacy assessment The assessment will be carried out at 0, 6 weeks and 18 weeks after starting the treatment protocol.
1-Imaging of the oral marker lesion Standardized photographs of the oral marker lesion for each patient will be taken with the same digital camera and setting, the surface area of the lesion will be outlined and measured using specific image software.
Histopathological analysis B-
The biopsy specimens for each patient will be taken at baseline and after 6 weeks of the treatment period and at 18 weeks for follow up then formalin-fixed and paraffin-embedded for:
- Conditions
- Oral Potentially Malignant Lesions
- Being tested
- Magnetite ZnO Composite Nanoparticles, Topical Placebo Gel
- Keywords
- Oral Potentially Malignant Lesions, OPL, Nanoparticles, ZNO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetite ZnO Composite NanoparticlesDrug
Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell
Topical Placebo GelDrug
Topical placebo gel containing water, glycerin and Hydroxypropyl methylcellulose will be applied 3 times daily for 6 weeks as a positive control group
| Study group | Role | What they receive |
|---|---|---|
| Magnetite Zno Composite Nanoparticles | Experimental | 5% topical ZnO-Fe3O4 Magnetic Composite NPs gel applied 3 times per day for 6 weeks Receives: Drug: Magnetite ZnO Composite Nanoparticles |
| Topical Placebo Gel | Placebo comparator | Topical Placebo Gel containing water, glycerin and Hydroxypropyl methylcellulose applied 3 times per day for 6 weeks Receives: Drug: Topical Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient
the surface area of the lesion will be outlined and measured using specific image software.
Measured: 6 weeks
Secondary outcomes (1)
Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start29 Feb 2024
- Primary completion30 Dec 2025
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Potentially Malignant LesionsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhane Adel Abdel Halim Omara, Ain Shams University
- Investigators
- Ola Ezzatt, A.Professor, Study director, Faculty of Dentistry-Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271564
- Sponsor's protocol ID
- FDASU-Rec IM012415
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided