CryotherapyNCT06193226
Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion
A study testing Cryotherapy in people with Cryotherapy and Oral Lesions, run by October 6 University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryotherapy, Oral Lesions
- What is being tested?
- Cryotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Patients who had benign intraoral epithelial lesions free of infection.
Who cannot join
- Patients with Reynaud's illness.
- Cold sensitivity.
- History of diabetes.
- Severe infections.
- Patients who had cryoglobulinemia.
- Cold urticaria.
- Patients who was receiving hemodialysis.
- Patients who was receiving immunosuppressive medication.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions.
Read the detailed description
Low-temperature applications were originally employed by the Egyptians to treat pain, and subsequently during the Franco-Prussian War for severed limbs. Hippocrates advocated the application of cold to lessen bruising, bleeding, and discomfort, while John Hunter wrote in 1777 that "the local tissue response to freezing includes local tissue necrosis, vascular stasis, and excellent healing." Using a solution of salt and ice, James Arnott (1851) was the first to describe and demonstrate this freezing technique for malignant breast tumors.
The term "cryotherapy" was used in 1908 to describe the use of extremely low temperatures to cure skin lesions. Currently, cryotherapy involves cooling the body's surface without destroying tissue, whereas in cryosurgery, sick tissues are frozen to death.
In the technique, several cryogens include: liquid nitroglycerine (-196 °C), Nitrous oxide (0°C), Solid CO2 (-78o C), Chlorodifluoromethane (-41°C), Dimethyl ether (-24 °C) and propane (-42 °C).
The intralesional technique, open method, or closed method can all be used to apply cryogens. The best application approach for big superficial cutaneous lesions is an open spray technique, in which the spray's nozzle is situated 1 cm away from the skin's surface, and the lesion is destroyed using either a paintbrush technique or a spiral technique.
- Conditions
- Cryotherapy, Oral Lesions
- Being tested
- Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Cryotherapy can be done in two ways:
- Open technique: Using cotton swabs or a cryogun spray, the cryogen is delivered directly to the lesion in this technique.
- Closed technique: Cryo-probes are used to apply the cryogen to the lesion in this procedure.
The spray's nozzle of the Cryogun spray -50 ◦C was situated 1 cm away from the skin's surface and applied on the oral lesion for 30 seconds. Each freezing cycle lasted 10 to 30 seconds, with the subsequent 60-second thaw interval lasting twice as long as the freezing time. The ice ball that formed during freezing was totally melted before the subsequent freezing process could begin.
The application process should went from the core out to the edges. The management of lesions that are too big to be frozen by a single spray requires many overlapping treatments of liquid nitrogen. Mucoceles and erosive lichen planus took 30 to 50 seconds to freeze, whereas fibromas and leukoplakia took 60 to 70 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Cryotherapy can be done in two ways:
1. Open technique: Using cotton swabs or a cryogun spray, the cryogen is delivered directly to the lesion in this technique.
2. Closed technique: Cryo-probes are used to apply the cryogen to the lesion in this procedure. Receives: Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain
The degree of pain was assessed by using Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"), which was documented on the 1st, 3rd, 7th, 21st days after the procedure
Measured: 21st days postoperatively
Secondary outcomes (2)
Epithelization of the lesion
Number of Participants with epithelization of the lesion was evaluated in the 1st postoperative month
Measured: 1st month postoperatively
The incidence of recurrence of the lesion
Recurrence of the lesion was evaluated in the 2nd postoperative month
Measured: 2nd month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Feb 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryotherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wessam Ibrahim Shehab, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193226
- Sponsor's protocol ID
- RECO6U/11-2023
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion
- ClinicalTrials.gov ID
- NCT06193226
- Acronym / sponsor ID
- RECO6U/11-2023
- Conditions
- Cryotherapy, Oral Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 5 Jan 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.
The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions.
Detailed description
Low-temperature applications were originally employed by the Egyptians to treat pain, and subsequently during the Franco-Prussian War for severed limbs. Hippocrates advocated the application of cold to lessen bruising, bleeding, and discomfort, while John Hunter wrote in 1777 that "the local tissue response to freezing includes local tissue necrosis, vascular stasis, and excellent healing." Using a solution of salt and ice, James Arnott (1851) was the first to describe and demonstrate this freezing technique for malignant breast tumors.
The term "cryotherapy" was used in 1908 to describe the use of extremely low temperatures to cure skin lesions. Currently, cryotherapy involves cooling the body's surface without destroying tissue, whereas in cryosurgery, sick tissues are frozen to death.
In the technique, several cryogens include: liquid nitroglycerine (-196 °C), Nitrous oxide (0°C), Solid CO2 (-78o C), Chlorodifluoromethane (-41°C), Dimethyl ether (-24 °C) and propane (-42 °C).
The intralesional technique, open method, or closed method can all be used to apply cryogens. The best application approach for big superficial cutaneous lesions is an open spray technique, in which the spray's nozzle is situated 1 cm away from the skin's surface, and the lesion is destroyed using either a paintbrush technique or a spiral technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: CryotherapyCryotherapy can be done in two ways: 1. Open technique: Using cotton swabs or a cryogun spray, the cryogen is delivered directly to the lesion in this technique. 2. Closed technique: Cryo-probes are used to apply the cryogen to the lesion in this procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients who had benign intraoral epithelial lesions free of infection.
Key exclusion criteria (8 listed)
- Patients with Reynaud's illness.
- Cold sensitivity.
- History of diabetes.
- Severe infections.
- Patients who had cryoglobulinemia.
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 |
|---|---|---|
| CryotherapyCryotherapy can be done in two ways: 1. Open technique: Using cotton swabs or a cryogun spray, the cryogen is delivered directly to the lesion in this technique. 2. Closed technique: Cryo-probes are used to apply the cryogen to the lesion in this procedure. The spray's nozzle of the Cryogun spray -50 ◦C was situated 1 cm away from the skin's surface and applied on the oral lesion for 30 seconds. Each freezing cycle lasted 10 to 30 seconds, with the subsequent 60-second thaw interval lasting twice as long as the freezing time. The ice ball that formed during freezing was totally melted before the subsequent freezing process could begin. The application process should went from the core out to the edges. The management of lesions that are too big to be frozen by a single spray requires many overlapping treatments of liquid nitrogen. Mucoceles and erosive lichen planus took 30 to 50 seconds to freeze, whereas fibromas and leukoplakia took 60 to 70 seconds. | Other | Cryotherapy |
Primary outcome
The degree of pain
Time frame: 21st days postoperatively
The degree of pain was assessed by using Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"), which was documented on the 1st, 3rd, 7th, 21st days after the procedure
2 secondary outcomes
Epithelization of the lesion
Time frame: 1st month postoperatively
The incidence of recurrence of the lesion
Time frame: 2nd month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Cryotherapy and Oral Lesions, run by October 6 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jan 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain (time frame: 21st days postoperatively). 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 9 Jan 2024.