Hypertrophic ScarNd-YAGNCT06347081
Effect of Nd-YAG Laser on Hypertrophic Scar
A study testing Nd- YAG laser at 532nm wavelength in people with Hypertrophic Scar, run by Cairo University at 1 site in Egypt.
Trial summary
A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- Nd- YAG laser at 532nm wavelength
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 28 Feb 2024
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients were excluded if they had taken oral retinoids in the last year.
- Patients had any skin defects.
- Patients had any history of photosensitivity.
- Patients experienced active skin diseases in the treatment regions (such as psoriasis, cancer, or autoimmune disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Long-Pulsed 1064 nm Nd:YAG Laser (Neodymium-doped Yttrium Aluminium Garnet) for Hypertrophic Scars: A Randomized Controlled Trial
A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.
T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.
Read the detailed description
Background: A hypertrophic scar is a serious health concern in the industrialized world. Objective: The impact of this study was to investigate the effect of the Nd-YAG laser at 532nm wavelength on hypertrophic scars. Patients and methods: Forty male and female patients with hypertrophic scars, ranging in age from fifteen to forty-five, were recruited from the burn patients' clinic within the Faculty of Physical Therapy, Cairo University, for this study. They were randomized into two equivalent groups. Group A (the control group) consisted of 20 patients who were given standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment. In contrast, Group B (the study group) consisted of 20 patients who were given 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. Treatment was conducted every 2 weeks for 14 sessions. Outcome measures included Vancouver Scar Scale score and scar volume. The assessment procedures were applied before the initiation of treatment (Pre), after 3 months (Post1) and after 7 months (Post 2) from the beginning of the treatment.
- Conditions
- Hypertrophic Scar
- Being tested
- Nd- YAG laser at 532nm wavelength
- Keywords
- Nd-YAG laser
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd- YAG laser at 532nm wavelengthProcedure or surgery
Nd-YAG laser at 532nm wavelength every 2 weeks for 14 sessions. patients will also receive standard medical care, nursing, physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients received standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment Receives: Procedure: Nd- YAG laser at 532nm wavelength |
| Laser group | Active comparator | Patients received 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. Receives: Procedure: Nd- YAG laser at 532nm wavelength |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypertrophic scar maturation
Changes in the scars' color, vascularity, elevation, and pliability were evaluated and scored using the Vancouver scale (VSS). VSS is from 0 to 14. A lower value indicates a better scar.
Measured: before treatment,12 weeks, and then 28 weeks of the treatment.
hypertrophic scar volume
Scar volume was determined using the negative-positive moulage method.
Measured: before treatment,12 weeks, and then 28 weeks of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 May 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies 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
- Model description
- one treatment one control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha F. mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347081
- Sponsor's protocol ID
- P.T.REC/012/00449
- Acronym
- Nd-YAG
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Long-Pulsed 1064 nm Nd:YAG Laser (Neodymium-doped Yttrium Aluminium Garnet) for Hypertrophic Scars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06347081
- Acronym / sponsor ID
- Nd-YAG / P.T.REC/012/00449
- Conditions
- Hypertrophic Scar
- Keywords
- Nd-YAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 4 Apr 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.
A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.
T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.
Detailed description
Background: A hypertrophic scar is a serious health concern in the industrialized world. Objective: The impact of this study was to investigate the effect of the Nd-YAG laser at 532nm wavelength on hypertrophic scars. Patients and methods: Forty male and female patients with hypertrophic scars, ranging in age from fifteen to forty-five, were recruited from the burn patients' clinic within the Faculty of Physical Therapy, Cairo University, for this study. They were randomized into two equivalent groups. Group A (the control group) consisted of 20 patients who were given standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment. In contrast, Group B (the study group) consisted of 20 patients who were given 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. Treatment was conducted every 2 weeks for 14 sessions. Outcome measures included Vancouver Scar Scale score and scar volume. The assessment procedures were applied before the initiation of treatment (Pre), after 3 months (Post1) and after 7 months (Post 2) from the beginning of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- one treatment one control group
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: Nd- YAG laser at 532nm wavelengthPatients received standard medical care, nursing, physiotherapy, and a sham laser during the course of treatment |
| Laser group | Active comparator | Procedure: Nd- YAG laser at 532nm wavelengthPatients received 532 nm laser radiation in addition to standard medical care, nursing, and physiotherapy. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients were excluded if they had taken oral retinoids in the last year.
- Patients had any skin defects.
- Patients had any history of photosensitivity.
- Patients experienced active skin diseases in the treatment regions (such as psoriasis, cancer, or autoimmune disease).
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 |
|---|---|---|
| Nd- YAG laser at 532nm wavelengthNd-YAG laser at 532nm wavelength every 2 weeks for 14 sessions. patients will also receive standard medical care, nursing, physiotherapy | Procedure or surgery | Laser group, Placebo |
Primary outcome
hypertrophic scar maturation
Time frame: before treatment,12 weeks, and then 28 weeks of the treatment.
Changes in the scars' color, vascularity, elevation, and pliability were evaluated and scored using the Vancouver scale (VSS). VSS is from 0 to 14. A lower value indicates a better scar.
hypertrophic scar volume
Time frame: before treatment,12 weeks, and then 28 weeks of the treatment.
Scar volume was determined using the negative-positive moulage method.
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 4 Apr 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.
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 Nd- YAG laser at 532nm wavelength in people with Hypertrophic Scar, 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 0 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 4 Apr 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?
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?
hypertrophic scar maturation (time frame: before treatment,12 weeks, and then 28 weeks of the treatment.). 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 4 Apr 2024.