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Punch Elevation and Microneedling in Treatment of Atrophic Acne Scars

Primary Purpose

Acne Scars

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Punch insturment
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Faculty of medicine AlAzhar University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

atrophic acne scar in face

Arm Description

Outcomes

Primary Outcome Measures

change in acne scars
Goodman and Baron's quantitative acne scar grading system

Secondary Outcome Measures

Full Information

First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05746052
Brief Title
Punch Elevation and Microneedling in Treatment of Atrophic Acne Scars
Official Title
Microneedling Versus Punch Elevation With Microneedling in Treatment of Atrophic Acne Scars: Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atrophic acne scar in face
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Punch insturment
Intervention Description
surgical and dermatological tool used mainly for skin biopsy and therapeutic skin disorders
Primary Outcome Measure Information:
Title
change in acne scars
Description
Goodman and Baron's quantitative acne scar grading system
Time Frame
4 weeks following end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Faculty of medicine AlAzhar University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Punch Elevation and Microneedling in Treatment of Atrophic Acne Scars

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