Acne ScarsNCT05746052
Punch Elevation and Microneedling in Treatment of Atrophic Acne Scars
A study testing Punch insturment in people with Acne Scars, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The ultimate goal of this study was to compare punch elevation and micro needling with PRP versus micro needling and PRP only in treatment of post acne scars, in an attempt to achieve better management of such condition. 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
- What is being tested?
- Punch insturment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Mar 2022
- 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 of both genders. Patients with Ice pick and box scars of any duration. Co-operative patients and patients are willing for the procedure. Patients of age 18 - 40 years
Who cannot join
- Presence of active acne lesions. Patients with active infection at the local site or recurrent herpes. Patients with history of bleeding disorders or anticoagulant medications Patients with keloid scarring or hypertrophic scar. patients with recurrent herpes simplex infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microneedling Versus Punch Elevation With Microneedling in Treatment of Atrophic Acne Scars: Comparative Study
The ultimate goal of this study was to compare punch elevation and micro needling with PRP versus micro needling and PRP only in treatment of post acne scars, in an attempt to achieve better management of such condition.
This is a prospective study that was carried out on 15 patients (their ages ranged from 19 to 32 years with a mean of 23 years. They are 6 males and 7 females, 7 patients were of skin photo type III, and 10 were rural residents), they presented with post acne facial scars, and attending the Dermatology and Andrology outpatient clinic of Al-Azhar University Hospital in (Assiut), between April 2021 and March 2022. Left side of face of the lesion of each patient will be treated by punch elevation two weeks before microneeedling with platlets rich plasma (PRP),the right side will be treated by microneedling with (PRP) only from the start, three sessions of microneedling will be done with 4 weeks interval.
Read more
Each patient had punch elevation for scars in left side at first session then dressing removed after 7 days after three weeks all patents received treatment on both sides of the face by micro needling with PRP.
During each session, topical anesthesia was applied over the area of interest on face and removed after 20 mints. Patients were placed in supine position with head stable, the skin was stretched and micro needling was carried out in vertical, horizontal and both diagonal directions for about 4-5 times. PRP (2 ml) were applied on the face. A total of three sessions of microneedling were performed at monthly intervals.
Follow-up of the patients was done before and after treatment by clinical examination and photography by comparing the photographs before and after therapy; Evolution of clinical response included extent of improvement and possible adverse effects including bleeding, and erythema. And PIH Clinical photos of the lesions had been taken before the first session and one month after the last session and assessed clinically to grade the severity of scarring proposed by Goodman and Baron's quantitative scale for acne scars at the baseline and the end of study. Patients' satisfaction had been done by using a quartile grading system (1 poorly satisfied, 2 satisfied or 3 very satisfied).
As regard efficacy of the procedures, we found significant improvement of atrophic acne scars, with significant reduction in number of acne scars as well as significant reduction in goodman score after treatment by punch elevation and micro needling with PRP, most of patients were satisfied after treatment, the side treated with punch elevation have statistically significant reduction in the number of the scar when compared to the right side.
- Conditions
- Acne Scars
- Being tested
- Punch insturment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch insturmentProcedure or surgery
surgical and dermatological tool used mainly for skin biopsy and therapeutic skin disorders
| Study group | Role | What they receive |
|---|---|---|
| atrophic acne scar in face | Other | Not described Receives: Procedure: Punch insturment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in acne scars
Goodman and Baron's quantitative acne scar grading system
Measured: 4 weeks following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Apr 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Mohamed Mahmoud, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746052
- Sponsor's protocol ID
- MSc/AZ.AST./DVA21/12/194/4/202
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling Versus Punch Elevation With Microneedling in Treatment of Atrophic Acne Scars: Comparative Study
- ClinicalTrials.gov ID
- NCT05746052
- Acronym / sponsor ID
- MSc/AZ.AST./DVA21/12/194/4/202
- Conditions
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 27 Feb 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.
The ultimate goal of this study was to compare punch elevation and micro needling with PRP versus micro needling and PRP only in treatment of post acne scars, in an attempt to achieve better management of such condition.
This is a prospective study that was carried out on 15 patients (their ages ranged from 19 to 32 years with a mean of 23 years. They are 6 males and 7 females, 7 patients were of skin photo type III, and 10 were rural residents), they presented with post acne facial scars, and attending the Dermatology and Andrology outpatient clinic of Al-Azhar University Hospital in (Assiut), between April 2021 and March 2022. Left side of face of the lesion of each patient will be treated by punch elevation two weeks before microneeedling with platlets rich plasma (PRP),the right side will be treated by microneedling with (PRP) only from the start, three sessions of microneedling will be done with 4 weeks interval.
Each patient had punch elevation for scars in left side at first session then dressing removed after 7 days after three weeks all patents received treatment on both sides of the face by micro needling with PRP.
During each session, topical anesthesia was applied over the area of interest on face and removed after 20 mints. Patients were placed in supine position with head stable, the skin was stretched and micro needling was carried out in vertical, horizontal and both diagonal directions for about 4-5 times. PRP (2 ml) were applied on the face. A total of three sessions of microneedling were performed at monthly intervals.
Follow-up of the patients was done before and after treatment by clinical examination and photography by comparing the photographs before and after therapy; Evolution of clinical response included extent of improvement and possible adverse effects including bleeding, and erythema. And PIH Clinical photos of the lesions had been taken before the first session and one month after the last session and assessed clinically to grade the severity of scarring proposed by Goodman and Baron's quantitative scale for acne scars at the baseline and the end of study. Patients' satisfaction had been done by using a quartile grading system (1 poorly satisfied, 2 satisfied or 3 very satisfied).
As regard efficacy of the procedures, we found significant improvement of atrophic acne scars, with significant reduction in number of acne scars as well as significant reduction in goodman score after treatment by punch elevation and micro needling with PRP, most of patients were satisfied after treatment, the side treated with punch elevation have statistically significant reduction in the number of the scar when compared to the right side.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrophic acne scar in face | Other | Procedure: Punch insturment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of both genders. Patients with Ice pick and box scars of any duration. Co-operative patients and patients are willing for the procedure. Patients of age 18 - 40 years
Key exclusion criteria (1 listed)
- Presence of active acne lesions. Patients with active infection at the local site or recurrent herpes. Patients with history of bleeding disorders or anticoagulant medications Patients with keloid scarring or hypertrophic scar. patients with recurrent herpes simplex infection
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 |
|---|---|---|
| Punch insturmentsurgical and dermatological tool used mainly for skin biopsy and therapeutic skin disorders | Procedure or surgery | atrophic acne scar in face |
Primary outcome
change in acne scars
Time frame: 4 weeks following end of treatment
Goodman and Baron's quantitative acne scar grading system
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 27 Feb 2023.
- 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.
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 Punch insturment in people with Acne Scars, run by Al-Azhar 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: finished, as of the sponsor's last update on 27 Feb 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?
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?
change in acne scars (time frame: 4 weeks following end of treatment). 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 27 Feb 2023.