Autologous Plasma Gel Injection Versus Polydioxanone Cog Threads Insertion for the Treatment of Atrophic Post-acne Scars: a Split-face

NCT06580691 | Completed DMC

• 1 other identifier: 36264PR126/3/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Both male and female patients, with atrophic acne scars All patients underwent one session of subcision before receiving: A: cog PDO threads on one side of the face (one session). B: plasma gel on the other side (one session). Primary outcomes: clinical improvements reported by physicians. Secondary out come: satisfaction levels of patients.

Conditions

Acne Vulgaris; Atrophic Acne Scar

Keywords

Acne vulgaris; Atrophic acne scars; Threads; Polydioxanone; Plasma gel

Outcome Measures

Primary Outcomes (4)

• Clinical improvement

  The improvement was assessed using the Goodman and Baron scale.

  after 3 month of the procedure

• Clinical improvement

  The improvement was assessed using the ECCA grading scale.

  after 3 month of the procedure

• Clinical improvement

  The improvement was assessed using the physician global assessment.

  after 3 month of the procedure

• Clinical improvement

  The improvement was assessed using the FASQoL questionnaire to assess the effect on patients quality of life.

  after 3 month of the procedure

Secondary Outcomes (2)

• Patients satisfaction.

  3 months from the procedure

• Side effects of the procedures.

  During 3 months from the procedure

Study Arms (2)

Subcision plus Plasma gel

ACTIVE COMPARATOR

The gel was injected into the scarred areas immediately after subcision.

Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

Subcision plus Cog PDO threads

ACTIVE COMPARATOR

Cog PDO threads were inserted using a blunt-tipped cannula in a "Z pattern" within the scarred areas, filling the pockets created by subcision.

Procedure: Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads

Interventions

Subcision plus Plasma gel injection Vs Subcision plus Cog PDO threads PROCEDURE

Plasma Gel: was injected into the scarred areas immediately after subcision. Thread Treatment: Cog PDO threads were inserted using a blunt-tipped cannula in a "Z pattern" within the scarred areas, filling the pockets created by subcision.

Subcision plus Cog PDO threads; Subcision plus Plasma gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old, with atrophic acne scars on both sides of their faces of any severity.

You may not qualify if:

• patients with keloidal tendencies or bleeding disorders.
• Participants with a history of recent isotretinoin use within 3 months
• Patients who underwent any procedure for treatment of acne scars during the last 6 months.

Sponsors & Collaborators

• Sameh Sarsik: lead

Study Sites (1)

Department of Dermatology and Venereology, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Wael Saudi, MD

  Misr University for Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: both male and female patients with atrophic acne scars

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: December 5, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)