CO2 Laser in ScarsPhase 1NCT05887232
Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars
A Phase 1 study testing Fractional CO2 laser and Fractional CO2 with Platelet Rich Plasma in people with CO2 Laser in Scars, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars. Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- CO2 Laser in Scars
- What is being tested?
- Fractional CO2 laser and Fractional CO2 with Platelet Rich Plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-50 years
- Fitzpatrick skin type III-V
- Presented with post-acne, post traumatic or post burn scars
- all those patients emotionally balanced with realistic expectations were included in the study.
Who cannot join
- scar that was less than 6 months old
- if they had an active infection or inflammatory skin condition
- having a history of malignancy
- a known connective tissue illness
- history of excessive bleeding or keloids
- unrealistic expectations
- pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars
Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.
Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.
Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.
- Conditions
- CO2 Laser in Scars
- Being tested
- Fractional CO2 laser, Fractional CO2 with Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laserProcedure or surgery
Patient in group A received FCL treatments four sessions with four weeks apart
Fractional CO2 with Platelet Rich PlasmaProcedure or surgery
Group B received four PRP and FCL sessions 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Fractional Co2 laser | Active comparator | Patient in group A received FCL treatment's four sessions four weeks apart. Receives: Procedure: Fractional CO2 laser |
| Platelet Rich Plasma | Active comparator | Group B received fractional CO2 with four Platelet Rich Plasma sessions,4 weeks apart. Receives: Procedure: Fractional CO2 with Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quartile grading scale for assessment of scars
Quartile grading scale was used to assess effectiveness of CO2 laser and CO2 laser with Platelet rich plasma in scars.Minimum score=0,Maximum Score=3 .Maximum score means better outcome.The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CO2 Laser in ScarsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Nigar, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887232
- Sponsor's protocol ID
- CMHAbbottabad1988
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 2 Jun 2023
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars
- ClinicalTrials.gov ID
- NCT05887232
- Acronym / sponsor ID
- CMHAbbottabad1988
- Conditions
- CO2 Laser in Scars
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Jun 2023 (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.
Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.
Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.
Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Co2 laser | Active comparator | Procedure: Fractional CO2 laserPatient in group A received FCL treatment's four sessions four weeks apart. |
| Platelet Rich Plasma | Active comparator | Procedure: Fractional CO2 with Platelet Rich PlasmaGroup B received fractional CO2 with four Platelet Rich Plasma sessions,4 weeks apart. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-50 years
- Fitzpatrick skin type III-V
- Presented with post-acne, post traumatic or post burn scars
- all those patients emotionally balanced with realistic expectations were included in the study.
Key exclusion criteria (7 listed)
- scar that was less than 6 months old
- if they had an active infection or inflammatory skin condition
- having a history of malignancy
- a known connective tissue illness
- history of excessive bleeding or keloids
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 |
|---|---|---|
| Fractional CO2 laserPatient in group A received FCL treatments four sessions with four weeks apart | Procedure or surgery | Fractional Co2 laser |
| Fractional CO2 with Platelet Rich PlasmaGroup B received four PRP and FCL sessions 4 weeks apart | Procedure or surgery | Platelet Rich Plasma |
Primary outcome
Quartile grading scale for assessment of scars
Time frame: 16 weeks
Quartile grading scale was used to assess effectiveness of CO2 laser and CO2 laser with Platelet rich plasma in scars.Minimum score=0,Maximum Score=3 .Maximum score means better outcome.The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session.
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 2 Jun 2023.
Related trials for CO2 Laser in Scars
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Enrolling by invitation
Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars
Post-Traumatic Atrophic Scar, Atrophic Scar
Not yet recruiting
Carbon Dioxide Laser-Assisted Delivery of Triamcinolone With or Without 5-Fluorouracil for Hypertrophic Burn Scars
Burn, Hypertrophic Scars
Recruiting
PRP Plus Fractional CO₂ Laser for Acne Scars
Post-Acne Atrophic Scars, Carbon Dioxide Lasers
Not yet recruitingPhase 4
Phenytoin in Treatment of Atrophic Post Acne Scars.
Atrophic Acne Scar
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 Phase 1 study testing Fractional CO2 laser and Fractional CO2 with Platelet Rich Plasma in people with CO2 Laser in Scars, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
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 4 inclusion and 7 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 2 Jun 2023. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quartile grading scale for assessment of scars (time frame: 16 weeks). 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 2 Jun 2023.