NCT05746052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 17, 2023

Last Update Submit

February 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in acne scars

    Goodman and Baron's quantitative acne scar grading system

    4 weeks following end of treatment

Study Arms (1)

atrophic acne scar in face

OTHER
Procedure: Punch insturment

Interventions

surgical and dermatological tool used mainly for skin biopsy and therapeutic skin disorders

atrophic acne scar in face

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine AlAzhar University

Asyut, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc researcher

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 27, 2023

Study Start

April 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations