Combined Procedures in the Treatment of Severe Acne Scars

January 25, 2024 updated by: Ahmed Omar Abdulrahman Hassan, Al-Azhar University

Efficiency Of Combination Of Scar Subcision With Platelet Rich Plasma, Polydioxanone Mono Threads Or Fractional Carbon Dioxide Laser In The Treatment Of Severe Atrophic Acne Scars: A Randomized Controlled Study

Many methods utilize for acne scar treatment including laser, cosmetic filler, microneedling, local tumescent, Subcision and chemical peels. These procedures can be used individually or as a combination therapy.

Combining procedures give better results. In our study we will try in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma, Polydioxanone mono threads or fractional Carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective controlled trial that will be conducted at Dermatology, venereology, and andrology Department, Al-Azhar university hospital, Assiut, in the period from March 2024 to March 2026, to assess the efficacy of combination of scar subcision with platelet rich plasma , polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars with 1:1:1 ratios and to compare between these modalities regarding safety and efficacy

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Patients with severe atrophic acne scars (as per Goodman and Baron's acne qualitative scar grading scale)

Exclusion Criteria:

  • Patients with active acne lesions.
  • Patients having a keloid formation tendency.
  • Patients with a history of bleeding disorder or severe anemia.
  • Pregnant or lactating women.
  • Patients received any treatment for scars in the last 6 months.
  • Patients using drugs causing photosensitivity or systemic retinoids in the previous 6 months (for laser group).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subcision plus platelet rich plasma
3 sessions of scar subcision with platelet rich plasma injection at the same session with one month interval
Procedure: Scar subcision
  • Subcision will be performed with18 gauge cannula at the margin of the scars on both sides of the face.
  • The cannula will be directed in a forward and backward motion producing a tunnel. Then, the it will be passed in sideways in a sweeping action to freeing up the scars from their bases.
  • Once finish, the pressure will be applied to reduce the bleeding and swelling. The topical antibiotic will be applied for 3 days.
Procedure: Platelet rich plasma injection
• 20 ml of autologous whole blood will be collected into tubes containing acid citrate dextrose and centrifuged at 1500 rpm for 10 minutes in order to get PRP at the top of the test tube. Then, the PRP will be further centrifuged at 3700 rpm for 10 minutes at room temperature of 22°C in order to obtain a platelet count 4.5 times higher than the base line. Platelet-poor plasma (PPP) will be partly removed and partly used to resuspend the platelets. Calcium gluconate will be added as an activator (1:9), i.e., 1 ml of calcium gluconate in 9 ml of PRP
Active Comparator: Subcision plus Polydioxanone mono threads
3 sessions of scar subcision followed by the insertion of Polydioxanone mono threads after the last session
Procedure: Scar subcision
  • Subcision will be performed with18 gauge cannula at the margin of the scars on both sides of the face.
  • The cannula will be directed in a forward and backward motion producing a tunnel. Then, the it will be passed in sideways in a sweeping action to freeing up the scars from their bases.
  • Once finish, the pressure will be applied to reduce the bleeding and swelling. The topical antibiotic will be applied for 3 days.
Procedure: Polydioxanone mono threads insertion
  • Topical anesthetic cream will be applied for halfan hour on the involved area.
  • polydioxanone mono threads (50 mm, 27 G) will be inserted at 1-cm spacing into the dermal layer of the skin; the threads will be arranged in a transverse and vertical line in the form of a mesh similar to cross-hatching technique.
  • The total numbers will range from 8 to 10 each side. The skin of the face will be stretched by the non-dominant hand of the physician and the needle will be inserted by the other hand through the required point.
Active Comparator: Subcision plus fractional carbon dioxide laser
3 sessions of scar subcision with Fractional carbon dioxide laser at the same session with one month interval
Procedure: Scar subcision
  • Subcision will be performed with18 gauge cannula at the margin of the scars on both sides of the face.
  • The cannula will be directed in a forward and backward motion producing a tunnel. Then, the it will be passed in sideways in a sweeping action to freeing up the scars from their bases.
  • Once finish, the pressure will be applied to reduce the bleeding and swelling. The topical antibiotic will be applied for 3 days.
Device: Fractional carbon dioxide laser
  • Topical anesthetic cream will be applied for 30 minutes before the procedure.
  • BX300 device from AMI inc.,Korea will be used.
  • Different settings will be used according to each individual case regarding the type of scar, severity and skin type fluence ranging from 36 to 42 j/cm2 will be used and pulse duration 1.8 ms.
  • In an attempt to avoid common side effects that occur with fractional laser treatment, a lower fluence will be used in the first session and depending on the results, the fluence will be increased per treatment session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Management of severe atrophic acne scars
Time Frame: 2 years
to assess the efficacy of the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars (As per Goodman and Baron's acne qualitative scar grading scale)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the 3 lines
Time Frame: 2 years

to compare between the combination of subcision with Platelet rich plasma, Polydioxanone mono threads or fractional carbon dioxide laser in the treatment of severe atrophic acne scars regarding efficacy and safety.

(As per Goodman and Baron's acne qualitative scar grading scale)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Director: Essam-Eldin M Mohamed, MD, Alazhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Severe acne scars

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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