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Clinical Trials/NCT06789874
NCT06789874CompletedPhase 2

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

Sheikh Zayed Medical College2 sites in 1 country126 target enrollmentStarted: April 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
126
Locations
2
Primary Endpoint
Observer Scar Assessment Scale

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intralesional Saline for acne scars (Group A)

Active Comparator

Intralesional Saline 5 to 10ml injected in the sacrs fortnightly for 3 months

Intervention: Intralesional Saline (Procedure)

Topical Trichloracetic acid for acne scars(Group B)

Active Comparator

35% trichloroacetic acid peel was applied to scars monthly for 3 months

Intervention: 35% trichloracetic acid peel (Procedure)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Kainat usman

Post Graduate Resident in Dermatology

Sheikh Zayed Medical College

Study Sites (2)

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