Acne Scars - AtrophicNCT05985265
Nano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars
A study testing Fat grafting in people with Acne Scars - Atrophic, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Acne Scars - Atrophic
- What is being tested?
- Fat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 29 May 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients older than 18 years who attend the Outpatient Clinics of Dermatology and Plastic Surgery Departments, Assiut University Hospital, with moderate to severe atrophic facial acne scars on both cheeks, as assessed using the Goodman and Baron Qualitative scar grading system (12), will be enrolled in the study.
Who cannot join
- include: pregnancy or lactation; active acne, history of deep chemical peeling or filler injection in the previous 6 months, history of keloid or hypertrophic scar formation; use of isotretinoin in the previous 6 months; active infection in the treatment area; bleeding tendencies; history of herpes simplex or herpes zoster infection on the face; and patients with unrealistic expectations.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Assiut University
Asyut, 71111
Mohammed H Abdelhafez, MBBS, +201099068855 ext. 0882315377, Dr.m.Zayan2@gmail.com
About this study
Official title: Assessment of Nano Fat Grafting Combined With Fractional Carbon Dioxide Laser Resurfacing Versus Nano Fat Grafting Alone in Atrophic Facial Acne Scars
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars
Read the detailed description
Acne scars is a world wide problem .though lots of treatment exists still mo gold standard for treatment of acne scars in this study.
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars
- Conditions
- Acne Scars - Atrophic
- Being tested
- Fat grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat graftingProcedure or surgery
Also called fractional carbon dioxide laser resurfacing
Nano fat grafting followed by fractional carbon dioxide laser resurfacing
| Study group | Role | What they receive |
|---|---|---|
| Nano fat grafting and fractional carbon dioxide laser resurfacing | Experimental | treating of atrophic acne scars with nano fat and fractional carbon dioxide laser Receives: Procedure: Fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of acne scar severity
as assessed using the Goodman and Baron Qualitative scar grading system before and after treatment on both sides of face, to determine the number of patients achieving two grades improvement vs one grade or no improvement
Measured: up to 24 weeks
Secondary outcomes (4)
Physician global assessment
two blinded observers will compare the before and after photographs separately on each facial side and will evaluate the improvement on a quartile grading scale as: poor,<25% improvement; fair, 25%-50% improvement; good, 51%-75% improvement; and excellent, >75% improvement.
Measured: up to 24 weeks
percent of reduction in scar count
count of the total and different types of acne scars was performed, before and after treatment on both sides of the face, and the percent of reduction was calculated
Measured: up to 24 weeks
Patient satisfaction
Patients will rate their overall satisfaction on a quartile grading system: 0, unsatisfied; 1, slightly satisfied; 2, satisfied; and 3, very satisfied
Measured: 1 year
Adverse events
erythema, edema, crusting, pigmentary changes, ecchymosis, and scarring, will be recorded
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion29 Apr 2024 (estimated)
- Study completion29 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acne Scars - AtrophicStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hisham Zayan, Assiut University
- Investigators
- youssef S farrag, MD, Principal investigator, Department of Plastic Surgery, professorWael S Ibraheem, MD, Principal investigator, Department of Plastic Surgery , Assistant lecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985265
- Sponsor's protocol ID
- nano fat injection
- Status last verified
- Aug 2023
- First submitted
- 15 Nov 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
PubMed 17199653Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
PubMed 11423843Chan NP, Ho SG, Yeung CK, Shek SY, Chan HH. Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Lasers Surg Med. 2010 Nov;42(9):615-23. doi: 10.1002/lsm.20974.
PubMed 20976801
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nano Fat Grafting Combined With Fractional Carbon Dioxide Laser Resurfacing Versus Nano Fat Grafting Alone in Atrophic Facial Acne Scars
- ClinicalTrials.gov ID
- NCT05985265
- Acronym / sponsor ID
- nano fat injection
- Conditions
- Acne Scars - Atrophic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 29 Apr 2024 (estimated)
- Study completion
- 29 May 2024 (estimated)
- First posted
- 14 Aug 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.
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars
Detailed description
Acne scars is a world wide problem .though lots of treatment exists still mo gold standard for treatment of acne scars in this study.
Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nano fat grafting and fractional carbon dioxide laser resurfacing | Experimental | Procedure: Fat graftingtreating of atrophic acne scars with nano fat and fractional carbon dioxide laser |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients older than 18 years who attend the Outpatient Clinics of Dermatology and Plastic Surgery Departments, Assiut University Hospital, with moderate to severe atrophic facial acne scars on both cheeks, as assessed using the Goodman and Baron Qualitative scar grading system (12), will be enrolled in the study.
Key exclusion criteria (1 listed)
- include: pregnancy or lactation; active acne, history of deep chemical peeling or filler injection in the previous 6 months, history of keloid or hypertrophic scar formation; use of isotretinoin in the previous 6 months; active infection in the treatment area; bleeding tendencies; history of herpes simplex or herpes zoster infection on the face; and patients with unrealistic expectations.
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 |
|---|---|---|
| Fat graftingAlso: fractional carbon dioxide laser resurfacingNano fat grafting followed by fractional carbon dioxide laser resurfacing | Procedure or surgery | Nano fat grafting and fractional carbon dioxide laser resurfacing |
Primary outcome
Clinical assessment of acne scar severity
Time frame: up to 24 weeks
as assessed using the Goodman and Baron Qualitative scar grading system before and after treatment on both sides of face, to determine the number of patients achieving two grades improvement vs one grade or no improvement
4 secondary outcomes
Physician global assessment
Time frame: up to 24 weeks
percent of reduction in scar count
Time frame: up to 24 weeks
Patient satisfaction
Time frame: 1 year
Adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 17199653Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
- Results publication: PubMed 11423843Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
- Results publication: PubMed 20976801Chan NP, Ho SG, Yeung CK, Shek SY, Chan HH. Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Lasers Surg Med. 2010 Nov;42(9):615-23. doi: 10.1002/lsm.20974.
- Individual participant dataSharing planned: No
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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.
youssef S farrag, MD principal investigator
Department of Plastic Surgery, professor
Wael S Ibraheem, MD principal investigator
Department of Plastic Surgery , Assistant lecture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat grafting in people with Acne Scars - Atrophic, run by Assiut 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 1 inclusion and 1 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 14 Aug 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 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?
Contact mohammed H Abdelhafez, MBBS (+201099068855, Dr.m.zayan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of acne scar severity (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05985265, which also lists 3 linked publications.
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 14 Aug 2023.