Acne Scars - AtrophicNCT06524011
Stromal Vascular Fraction Enriched PRP in Treatment of Post-acne Scars
A study testing Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone in people with Acne Scars - Atrophic, run by Zagazig University at 1 site in Egypt.
Trial summary
in a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars - Atrophic
- What is being tested?
- Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2024to Feb 2026
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with atrophic post acne scars without any previous treatment trials.
- adequate blood picture, no anemia, no bleeding or platelet disorders.
Who cannot join
- pregnant and lactating females.
- elderly.
- patients with bleeding tendencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Split Face Comparative Study of Stromal Vascular Fraction Enriched PRP Versus Each Alone in Treatment of Atrophic Post-acne Scars
in a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF
- Conditions
- Acne Scars - Atrophic
- Being tested
- Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each aloneBiological
Adipose derived stromal vascular fraction cells will be aspirated and isolated from patient autologous adipose tissue and used to enrich patient's autologous platelet rich plasma then will be used to treat atrophic post acne scars versus each alone.
| Study group | Role | What they receive |
|---|---|---|
| SVF enriched PRP vs PRP | Experimental | Not described Receives: Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone |
| SVF enriched PRP vs SVF | Active comparator | Not described Receives: Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone |
| PRP vs SVF | Active comparator | Not described Receives: Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in severity of acne scars using Goodman scoring system
at baseline, acne scars will be assessed clinically using the 4 point grading system proposed by Goodman \&colleagues in 2006, patients' complaints and expectations will be addressed as well and the impact of acne scars on patients' quality of life will be investigated using the dermatology life quality index (DLQI). Goodman scoring system will be used at the last session and at the follow up visit to measure the change pre and post treatment.
Measured: 3 monthly sessions and follow up for 3 months after the last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - AtrophicStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mona El Radi Kamal Mohamed Emam, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524011
- Sponsor's protocol ID
- Dr. MonaRadi
- Status last verified
- Jul 2024
- First submitted
- 6 Oct 2023
- Last updated
- 29 Jul 2024
- Results posted
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split Face Comparative Study of Stromal Vascular Fraction Enriched PRP Versus Each Alone in Treatment of Atrophic Post-acne Scars
- ClinicalTrials.gov ID
- NCT06524011
- Acronym / sponsor ID
- Dr. MonaRadi
- Conditions
- Acne Scars - Atrophic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Jul 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 a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SVF enriched PRP vs PRP | Experimental | Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone |
| SVF enriched PRP vs SVF | Active comparator | Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone |
| PRP vs SVF | Active comparator | Biological: Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with atrophic post acne scars without any previous treatment trials.
- adequate blood picture, no anemia, no bleeding or platelet disorders.
Key exclusion criteria (3 listed)
- pregnant and lactating females.
- elderly.
- patients with bleeding tendencies.
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 |
|---|---|---|
| Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each aloneAdipose derived stromal vascular fraction cells will be aspirated and isolated from patient autologous adipose tissue and used to enrich patient's autologous platelet rich plasma then will be used to treat atrophic post acne scars versus each alone. | Biological | PRP vs SVF, SVF enriched PRP vs PRP, SVF enriched PRP vs SVF |
Primary outcome
change in severity of acne scars using Goodman scoring system
Time frame: 3 monthly sessions and follow up for 3 months after the last visit
at baseline, acne scars will be assessed clinically using the 4 point grading system proposed by Goodman \&colleagues in 2006, patients' complaints and expectations will be addressed as well and the impact of acne scars on patients' quality of life will be investigated using the dermatology life quality index (DLQI). Goodman scoring system will be used at the last session and at the follow up visit to measure the change pre and post treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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 Stromal vascular fraction (SVF) enriched platelet rich plasma (PRP) versus each alone in people with Acne Scars - Atrophic, run by Zagazig 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 2 inclusion and 3 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 29 Jul 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. 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?
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?
change in severity of acne scars using Goodman scoring system (time frame: 3 monthly sessions and follow up for 3 months after the last visit). 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 29 Jul 2024.