NCT06789874

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 11, 2025

Last Update Submit

January 16, 2025

Conditions

Atrophic Acne ScarAtrophic Acne Scarring

Keywords

Acne scarsTCA peelIntralesional saline

Outcome Measures

Primary Outcomes (1)

  • Observer Scar Assessment Scale

    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

Study Arms (2)

Intralesional Saline for acne scars (Group A)

ACTIVE COMPARATOR

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

Procedure: Intralesional Saline

Topical Trichloracetic acid for acne scars(Group B)

ACTIVE COMPARATOR

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

Procedure: 35% trichloracetic acid peel

Interventions

Intralesional SalinePROCEDURE

Intralesional Saline injected in scars

Intralesional Saline for acne scars (Group A)
35% trichloracetic acid peelPROCEDURE

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

Topical Trichloracetic acid for acne scars(Group B)

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheikh Zayed Medical College/Hospital

Rahimyarkhan, Punjab Province, 62400, Pakistan

Location

Sheikh Zayed Medical College/Hospital

Rahimyarkhan, Punjab Province, 644200, Pakistan

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Resident in Dermatology

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 23, 2025

Study Start

April 1, 2023

Primary Completion

June 30, 2023

Study Completion

October 31, 2023

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)