ScarNCT05293652
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar
A study testing Iontophoresis, Phonophoresis and traditional PT program in people with Scar and Hydrocortisone, run by Horus University at 1 site in Egypt.
Trial summary
The purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar, Hydrocortisone, Iontophoresis
- What is being tested?
- Iontophoresis, Phonophoresis and traditional PT program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 15 Feb 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders
- same approach of medications
- scar size varies from 5-15 cm
Who cannot join
- have cardiac / pacemakers
- have significant health problems
- obese patients (BMI more than 30)
- uncooperative patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
Damietta, 34518
About this study
The purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.
Read the detailed description
Scar contractures develop and extend to the underlying connective tissue and then muscles, leading to reduction in joint range of motion and affecting the day-to-day activities.
Most patients (irrespective of age, gender and ethnicity) believe that even a small improvement in scarring is worthwhile , any research that may help improve scar outcome is meaningful.
The need of this study has developed from the rarity of information about the difference between the effectiveness of iontophoresis and phonophoresis in enhancing the overall appearance of surgical scar.
- Conditions
- Scar, Hydrocortisone, Iontophoresis, Phonophoresis
- Being tested
- Iontophoresis, Phonophoresis, traditional PT program
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IontophoresisOther
Hydrocortisone iontophoresis
PhonophoresisOther
Hydrocortisone Phonophoresis
traditional PT programOther
Ultrasound and deep friction massage
| Study group | Role | What they receive |
|---|---|---|
| Iontophosresis group | Experimental | Not described Receives: Other: Iontophoresis; Other: traditional PT program |
| Phonophoresis group | Experimental | Not described Receives: Other: Phonophoresis; Other: traditional PT program |
| Traditional group | Experimental | Not described Receives: Other: traditional PT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar pliability
assessment of change in Scar pliability by using tonometer device
Measured: at baseline and after 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Sep 2021
- Primary completion15 Jan 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elnaser Abd Elfattah Ghareeb, Horus University
- Investigators
- Mohamed Abdelnaser, Assistant lecturer, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293652
- Sponsor's protocol ID
- Phd_mghareeb
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar
- ClinicalTrials.gov ID
- NCT05293652
- Acronym / sponsor ID
- Phd_mghareeb
- Conditions
- Scar, Hydrocortisone, Iontophoresis, Phonophoresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 24 Mar 2022 (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 purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.
Detailed description
Scar contractures develop and extend to the underlying connective tissue and then muscles, leading to reduction in joint range of motion and affecting the day-to-day activities.
Most patients (irrespective of age, gender and ethnicity) believe that even a small improvement in scarring is worthwhile , any research that may help improve scar outcome is meaningful.
The need of this study has developed from the rarity of information about the difference between the effectiveness of iontophoresis and phonophoresis in enhancing the overall appearance of surgical scar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iontophosresis group | Experimental | Other: Iontophoresis, Other: traditional PT program |
| Phonophoresis group | Experimental | Other: Phonophoresis, Other: traditional PT program |
| Traditional group | Experimental | Other: traditional PT program |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders
- same approach of medications
- scar size varies from 5-15 cm
Key exclusion criteria (4 listed)
- have cardiac / pacemakers
- have significant health problems
- obese patients (BMI more than 30)
- uncooperative patients
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 |
|---|---|---|
| IontophoresisHydrocortisone iontophoresis | Other | Iontophosresis group |
| PhonophoresisHydrocortisone Phonophoresis | Other | Phonophoresis group |
| traditional PT programUltrasound and deep friction massage | Other | Iontophosresis group, Phonophoresis group, Traditional group |
Primary outcome
Scar pliability
Time frame: at baseline and after 3 months of intervention
assessment of change in Scar pliability by using tonometer device
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 24 Mar 2022.
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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.
Mohamed Abdelnaser, Assistant lecturer principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis, Phonophoresis and traditional PT program in people with Scar and Hydrocortisone, run by Horus 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 4 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 24 Mar 2022. 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?
Scar pliability (time frame: at baseline and after 3 months of intervention). 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 24 Mar 2022.