To Compare the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars

January 16, 2025 updated by: Kainat usman, Sheikh Zayed Medical College

Comparing the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars

This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acne vulgaris is a common skin problem affecting adolescents and adults. It is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.A randomized controlled trial was conducted at the Dermatology Department, Sheikh Zayed Hospital, Rahim Yar Khan, from 1st April 2023 to 31st October 2023. 126 patients were enrolled. Scar grading was based on Goodman and Baron's Qualitative Scar Classification. The Observer Scar Assessment Scale (OSAS) was used by dermatologists. Patients rated their acne scars using the Visual Disease Severity Scale. Photographs were taken for comparison. Efficacy was defined as ≥50% improvement in the OSAS.

Study Type

Interventional

Enrollment (Actual)

126

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 Locations

  • Pakistan
    • Punjab
      • Rahimyarkhan, Punjab, Pakistan, 62400
        • Sheikh Zayed Medical college/hospital
      • Rahimyarkhan, Punjab, Pakistan, 644200
        • Sheikh Zayed Medical college/hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 13-50 years
  • Clinically diagnosed patients of atrophic acne scars on face
  • duration of more than 6 months
  • no history of any procedural intervention in past 3 months

Exclusion Criteria:

  • history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities
  • history of use of oral isotretinoin, OCPs, steroids or immunosuppressants
  • pregnant or lactating females

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: Intralesional Saline for acne scars (Group A)
Intralesional Saline 5 to 10ml injected in the sacrs fortnightly for 3 months
Procedure: Intralesional Saline
Intralesional Saline injected in scars
Active Comparator: Topical Trichloracetic acid for acne scars(Group B)
35% trichloroacetic acid peel was applied to scars monthly for 3 months
Procedure: 35% trichloracetic acid peel
35%Trichloracetic acid peel was applied to scars monthly for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observer Scar Assessment Scale
Time Frame: clinical assessment will be done monthly for 6 months
efficacy was labelled as improvement on observer scar assessment scale by >50% compared to baseline. Patient's satisfaction was recorded as 'not satisfied' (VAS score of 1-5), 'Satisfied' (VAS score of 6-7), and 'very satisfied' (Vas score of 8-10)
clinical assessment will be done monthly for 6 months

Collaborators and Investigators

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

Sponsor

Sheikh Zayed Medical College

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 (Actual)

April 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

January 11, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sheikhzayedmedicalcollege SZMC

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

product manufactured in and exported from the U.S.

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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