Hypertrophic ScarsNCT06649188
Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar
A study testing Magnesium Sulphate Iontophoresis and traditional physical therapy program in people with Hypertrophic Scars, run by Cairo University at 1 site in Egypt.
Trial summary
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group): 1. Group A: Experimental: Magnesium Sulphate Iontophoresis for Postburn Hypertrophic Scar The study group includes 40 postburn hypertrophic scar patients will receive Magnesium Sulphate iontophoresis twice a week… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- Magnesium Sulphate Iontophoresis and traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 15 Jan 2025
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-Patient with hypertrophic scar (3-6) months after burn healing. 2-Age range between 20-40 years. 3-Male and female patients will participate in the study. 4-All patients have a post-burn hypertrophic scar at different body sites. 5-All patients enrolled on the study will have their informed consent.
Who cannot join
- 1-Patients with prior medical histories of cardiac arrhythmias. 2-Patients with cardiac pacemakers. 3-Patients with orthopaedic implants. 4-Areas of skin with lesions and impaired sensation. 5-During pregnancy and breastfeeding. 6-Patient with diabetes mellitus. 7-Patients with a history of hypersensitivity or adverse reactions associated with (MgSO4).
- 8-Recent MgSO4 administration 6 months before the study. 9-Any subject complaining of psychiatric disorders or neurological disorders such as myasthenia gravis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Giza
Physical Therapy Cairo University, 0237617691, Info@pt.cu.edu.eg
About this study
Official title: Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar Post-Burn
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):
- Group A: Experimental: Magnesium Sulphate Iontophoresis for Postburn Hypertrophic Scar The study group includes 40 postburn hypertrophic scar patients will receive Magnesium Sulphate iontophoresis twice a week for 4 weeks; in addition to their traditional physical therapy program (deep friction massage, stretching and pressure therapy).
- Group B: Control: Traditional physical therapy for postburn hypertrophic scar This group includes 40 patients with postburn hypertrophic scar who will receive only the traditional PT (deep friction massage, stretching and pressure therapy) 2 sessions per week for 4 weeks
Read the detailed description
- Assessment measures and procedures:
- High resolution ultrasonography [Time Frame: Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment (after 4 and 12 weeks from the beginning of treatment). High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency (Elrefaie et al., 2020).
- Patient and observer scar assessment scale [Time Frame: Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 4 and 12 weeks after treatment. The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse (Lenzi et al., 2019).
- Treatment procedures:
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED) The phoresors II auto model PM850 IOMED allows the user to deliver a specific dose from 0 to 80 mA/min, control the current from 0 to 4 mA and automatically calculates required time for the selected dose. Current ramp-up and down, shut-off, error messages and safety checks are also performed automatically. The builtin option for manual current shut-off is an added safety feature (Teslim et al., 2013).
- Electrodes: Active-Anode (Drug Delivery).
- Drug Used: MgSO4 Aqueous Solution.
- Drug Ion Polarity: Positive Polarity. Prior to intervention, skin sensation will be assessed using warm water in a test-tube (temperature), pin prick (pain) and cotton wool (light touch) to ascertain the skin sensitivity.
Before each treatment, the surface area of the scar will be cleaned with cotton wool and alcohol to reduce skin resistance. 2.5 ML MgSO4 will be applied to the active positive electrode via a syringe with concentration 100 mg/cm2 (it's available in hospitals and not found in pharmacies), active electrode will be placed directly over the hypertrophic scar. The dispersive electrode will be applied to the skin 6 inch distal from the active electrode (Evans et al., 2001).
The dose needed will be selected in the device which is 75 mA/min (Teslim et al., 2013) then the current will be increased gradually depending on subject tolerance, ranging from 2 to 4 mA, the device will automatically calculate the required time for the selected dose. The interventions will be repeated twice a week for 4 weeks (Teslim et al., 2013). If a subject reports any sensation other than tingling, the treatment will be stopped, the electrodes will be removed and the skin will be inspected (Evans et al., 2001).
- Conditions
- Hypertrophic Scars
- Being tested
- Magnesium Sulphate Iontophoresis, traditional physical therapy program
- Keywords
- Iontophoresis, Post burn
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulphate IontophoresisDevice
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED) The phoresors II auto model PM850 IOMED allows the user to deliver a specific dose from 0 to 80 mA/min, control the current from 0 to 4 mA and automatically calculates required time for the selected dose. Current ramp-up and down, shut-off, error messages and safety checks are also performed automatically. The builtin option for manual current shut-off is an added safety feature (Teslim et al., 2013).
- Electrodes: Active-Anode (Drug Delivery).
- Drug Used: MgSO4 Aqueous Solution.
- Drug Ion Polarity: Positive Polarity.
traditional physical therapy programOther
Deep friction massage, stretching and pressure therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Magnesium Sulphate Iontophoresis | Experimental | Not described Receives: Device: Magnesium Sulphate Iontophoresis; Other: traditional physical therapy program |
| Group B: Control | Sham comparator | Not described Receives: Other: traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hypertrophic scar thickness
High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency (Elrefaie et al., 2020).
Measured: 4 weeks
The change of patient and observer scar assessment scale score
The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse (Lenzi et al., 2019).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649188
- Sponsor's protocol ID
- P.T.REC/012/005334
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar Post-Burn
- ClinicalTrials.gov ID
- NCT06649188
- Acronym / sponsor ID
- P.T.REC/012/005334
- Conditions
- Hypertrophic Scars
- Keywords
- Iontophoresis, Post burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 18 Oct 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.
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):
- Group A: Experimental: Magnesium Sulphate Iontophoresis for Postburn Hypertrophic Scar The study group includes 40 postburn hypertrophic scar patients will receive Magnesium Sulphate iontophoresis twice a week for 4 weeks; in addition to their traditional physical therapy program (deep friction massage, stretching and pressure therapy).
- Group B: Control: Traditional physical therapy for postburn hypertrophic scar This group includes 40 patients with postburn hypertrophic scar who will receive only the traditional PT (deep friction massage, stretching and pressure therapy) 2 sessions per week for 4 weeks
Detailed description
- Assessment measures and procedures:
- High resolution ultrasonography [Time Frame: Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment (after 4 and 12 weeks from the beginning of treatment). High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency (Elrefaie et al., 2020).
- Patient and observer scar assessment scale [Time Frame: Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 4 and 12 weeks after treatment. The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse (Lenzi et al., 2019).
- Treatment procedures:
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED) The phoresors II auto model PM850 IOMED allows the user to deliver a specific dose from 0 to 80 mA/min, control the current from 0 to 4 mA and automatically calculates required time for the selected dose. Current ramp-up and down, shut-off, error messages and safety checks are also performed automatically. The builtin option for manual current shut-off is an added safety feature (Teslim et al., 2013).
- Electrodes: Active-Anode (Drug Delivery).
- Drug Used: MgSO4 Aqueous Solution.
- Drug Ion Polarity: Positive Polarity. Prior to intervention, skin sensation will be assessed using warm water in a test-tube (temperature), pin prick (pain) and cotton wool (light touch) to ascertain the skin sensitivity.
Before each treatment, the surface area of the scar will be cleaned with cotton wool and alcohol to reduce skin resistance. 2.5 ML MgSO4 will be applied to the active positive electrode via a syringe with concentration 100 mg/cm2 (it's available in hospitals and not found in pharmacies), active electrode will be placed directly over the hypertrophic scar. The dispersive electrode will be applied to the skin 6 inch distal from the active electrode (Evans et al., 2001).
The dose needed will be selected in the device which is 75 mA/min (Teslim et al., 2013) then the current will be increased gradually depending on subject tolerance, ranging from 2 to 4 mA, the device will automatically calculate the required time for the selected dose. The interventions will be repeated twice a week for 4 weeks (Teslim et al., 2013). If a subject reports any sensation other than tingling, the treatment will be stopped, the electrodes will be removed and the skin will be inspected (Evans et al., 2001).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Magnesium Sulphate Iontophoresis | Experimental | Device: Magnesium Sulphate Iontophoresis, Other: traditional physical therapy program |
| Group B: Control | Sham comparator | Other: traditional physical therapy program |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1-Patient with hypertrophic scar (3-6) months after burn healing. 2-Age range between 20-40 years. 3-Male and female patients will participate in the study. 4-All patients have a post-burn hypertrophic scar at different body sites. 5-All patients enrolled on the study will have their informed consent.
Key exclusion criteria (2 listed)
- 1-Patients with prior medical histories of cardiac arrhythmias. 2-Patients with cardiac pacemakers. 3-Patients with orthopaedic implants. 4-Areas of skin with lesions and impaired sensation. 5-During pregnancy and breastfeeding. 6-Patient with diabetes mellitus. 7-Patients with a history of hypersensitivity or adverse reactions associated with (MgSO4).
- 8-Recent MgSO4 administration 6 months before the study. 9-Any subject complaining of psychiatric disorders or neurological disorders such as myasthenia gravis
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 |
|---|---|---|
| Magnesium Sulphate IontophoresisIontophoretic drug delivery system (phoresors II auto model PM850 IOMED) The phoresors II auto model PM850 IOMED allows the user to deliver a specific dose from 0 to 80 mA/min, control the current from 0 to 4 mA and automatically calculates required time for the selected dose. Current ramp-up and down, shut-off, error messages and safety checks are also performed automatically. The builtin option for manual current shut-off is an added safety feature (Teslim et al., 2013). * Electrodes: Active-Anode (Drug Delivery). * Drug Used: MgSO4 Aqueous Solution. * Drug Ion Polarity: Positive Polarity. | Device | Group A: Magnesium Sulphate Iontophoresis |
| traditional physical therapy programDeep friction massage, stretching and pressure therapy. | Other | Group A: Magnesium Sulphate Iontophoresis, Group B: Control |
Primary outcome
Change of hypertrophic scar thickness
Time frame: 4 weeks
High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency (Elrefaie et al., 2020).
The change of patient and observer scar assessment scale score
Time frame: 4 weeks
The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse (Lenzi et al., 2019).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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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 study testing Magnesium Sulphate Iontophoresis and traditional physical therapy program in people with Hypertrophic Scars, run by Cairo 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 2 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 18 Oct 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. 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.
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 Aya Gamal Elsayed, PHD (+0201001475959, drayasa3ada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of hypertrophic scar thickness (time frame: 4 weeks). 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 18 Oct 2024.