Atrophic Acne ScarEarly Phase 1PRPNCT04580758
Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars
A Early Phase 1 study testing Fractional laser with PRP fluid or PRP gel in people with Atrophic Acne Scar, run by Yasmine Ahmed Abd El-Maguid El-Hadidy at 1 site in Egypt.
Trial summary
This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Fractional laser with PRP fluid or PRP gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2020to 31 Jan 2021
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18
- Both genders
- Skin types III - V
- Willingness and ability to comply with the requirements of the protocol
- Atrophic acne scars
Who cannot join
- Patients with active acne
- Patients with herpes labialis, bacterial infections, other infections such as HBV. HCV or HIV.
- Oral isotretinoin use in the previous 6 months
- Pregnancy
- Tendency to keloid formation
- Patients with severe systemic illness or malignancy
- Patients with connective tissue diseases
- Patients with bleeding tendencies or any other hematological disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy Hospital
Giza
Yasmin A El Hadidy, MB BCh, 01142479792, yasmin_ahmed_92@yashoo.com
Heba A Abd El Kader, MD
About this study
Official title: Fractional CO2 Laser Combined With Platelet Rich Plasma Fluid Versus Gel Form in Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars
Read the detailed description
The study will include 20 patients, treated with fractional CO2 laser plus PRP fluid on one side of the face and fractional CO2 laser plus PRP gel on the other side.
Choosing which side of the face will be injected with PRP fluid and which side will be injected with PRP gel will be chosen according to a randomization table for each patient.
- Conditions
- Atrophic Acne Scar
- Being tested
- Fractional laser with PRP fluid or PRP gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional laser with PRP fluid or PRP gelCombination product
20 participants divided into 2 groups of 10 10 participants will do Fractional laser with PRP fluid sessions and 10 participants will do Fractional laser with PRP gel
| Study group | Role | What they receive |
|---|---|---|
| Fractional laser with PRP fluid | Active comparator | Fractional CO2 laser then the PRP is injected afterwards Receives: Combination Product: Fractional laser with PRP fluid or PRP gel |
| Fractional laser with PRP gel | Active comparator | Fractional CO2 laser then the PRP gel is injected afterwards Receives: Combination Product: Fractional laser with PRP fluid or PRP gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel
Effectiveness of each combination will be measured with OCT, depth of a fixed scar on each side of the face will be measured at baseline and then compared with 1 month after the last session and 3 months after the last session
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start25 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Acne 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasmine Ahmed Abd El-Maguid El-Hadidy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmine Ahmed Abd El-Maguid El-Hadidy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580758
- Sponsor's protocol ID
- Kasr El Aini Hospital
- Acronym
- PRP
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser Combined With Platelet Rich Plasma Fluid Versus Gel Form in Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04580758
- Acronym / sponsor ID
- PRP / Kasr El Aini Hospital
- Conditions
- Atrophic Acne Scar
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yasmine Ahmed Abd El-Maguid El-HadidyUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars
Detailed description
The study will include 20 patients, treated with fractional CO2 laser plus PRP fluid on one side of the face and fractional CO2 laser plus PRP gel on the other side.
Choosing which side of the face will be injected with PRP fluid and which side will be injected with PRP gel will be chosen according to a randomization table for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional laser with PRP fluid | Active comparator | Combination Product: Fractional laser with PRP fluid or PRP gelFractional CO2 laser then the PRP is injected afterwards |
| Fractional laser with PRP gel | Active comparator | Combination Product: Fractional laser with PRP fluid or PRP gelFractional CO2 laser then the PRP gel is injected afterwards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18
- Both genders
- Skin types III - V
- Willingness and ability to comply with the requirements of the protocol
- Atrophic acne scars
Key exclusion criteria (8 listed)
- Patients with active acne
- Patients with herpes labialis, bacterial infections, other infections such as HBV. HCV or HIV.
- Oral isotretinoin use in the previous 6 months
- Pregnancy
- Tendency to keloid formation
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 laser with PRP fluid or PRP gel20 participants divided into 2 groups of 10 10 participants will do Fractional laser with PRP fluid sessions and 10 participants will do Fractional laser with PRP gel | Combination product | Fractional laser with PRP fluid, Fractional laser with PRP gel |
Primary outcome
Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel
Time frame: one year
Effectiveness of each combination will be measured with OCT, depth of a fixed scar on each side of the face will be measured at baseline and then compared with 1 month after the last session and 3 months after the last session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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AVAVA MIRIA General Use
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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 Early Phase 1 study testing Fractional laser with PRP fluid or PRP gel in people with Atrophic Acne Scar, run by Yasmine Ahmed Abd El-Maguid El-Hadidy 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 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Heba A Abd El Kader, MD (01142479792, H_abdelkader2007@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel (time frame: one year). 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 8 Oct 2020.