Efficacy of Saline Injection Therapy in Atrophic Acne Scars

Sponsor
Jinnah Postgraduate Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT04197245
Collaborator
(none)
49
1
1
6.9
7.1

Study Details

Study Description

Brief Summary

The purpose of the study was to determine the efficacy of saline injection in post-acne atrophic scars on face. All patients with mild, moderate & severe post-acne atrophic scars, above age of 15 years without any co-morbid conditions were included in the study. After giving local anesthesia, the isotonic saline solution has been administered intra- and sub-dermally in post-acne atrophic scars on face. The sessions were done weekly, for 12 weeks. The results were assessed by the photographs, sharquie scoring system & Dermatology Life Quality Index score at the start and at the end of the treatment. SPSS 23 was used to analyze the data. The analysis of data showed that the response of saline injection was significant in mild and moderate scars, without any significant side effects.

Condition or Disease Intervention/Treatment Phase
  • Drug: saline injection therapy in post-acne atrophic scars
Early Phase 1

Detailed Description

The study was conducted for the determination of saline injection effectiveness in post-acne atrophic scars in patients referred to the department of dermatology in Jinnah postgraduate medical centre, Karachi, Pakistan from January 2019 to July 2019, after receiving approval letter from the institutional ethical and research committee of the hospital.

Forty-nine patients were selected after calculating the sample size through the NCSS software. The patients were selected with the age ranging from 15-35years of either gender, after excluding hypertension, cardiovascular disorders, pregnancy, lactation & hypersensitivity to lidocaine. The procedure has been explained to each patient & written consent was taken. Before starting treatment, the photographs were taken for each patient with their permission & sharquie scoring system for grading scars and Dermatology Life Quality Index scores were calculated.

During each session, after all sterilization techniques, patient has been pain-free with the application of local anesthesia, then 0.9% isotonic saline is injected intra- and sub-dermally in post-acne atrophic scars with 1cc syringe of 30-gauge needles, on both sides of face. The volume of saline injected depends upon the numbers, width and depth of the individual scars. It has been injected up to scar elevation by overfilling with saline & spreading into surrounding tissue as well.

A total of 12 sessions were done weekly. The efficacy of treatment has been assessed by comparing photographs, sharquie scoring system for grading scars and Dermatology Life Quality Index scores at the start and at the end of treatment.

The sharquie scoring system for grading scars has been calculated through assessing number of scars, proportion of the area of the face involved, morphology of scars including color or type and social behavior of the patient. The final scores obtained by adding all scores, were compared with the initial ones, at the end of treatment.

The Dermatology Life Quality Index (DLQI) has been calculated through simple questionnaire, consisting of 10 questions related to the effect of disease and its treatment on the daily activities of patient and the impact on the social behavior of the patient towards friends and relatives. DLQI scores has been interpreted, regarding the effect on patients' life as follows:

  • 0-1 = No effect

  • 2-5 = Small effect

  • 6-10 = Moderate effect

  • 11-20 = Very large effect

  • 21-30 = Extremely large effect

At the end of treatment, results were compared to assess the improvement in everyday activities and social behaviors of the patients.

The evaluation of result was done by SPSS version 23. The side effects were also assessed regarding erythema, itching , pain & dys-pigmentation.

In this study three patients of post-acne atrophic scars also had atrophic scars due to trauma in the childhood, on their face. On the request of the patients, these scars were also filled with saline injection, in addition to their post-acne atrophic scars.

During treatment, change in the post-acne pigmentation, skin tightening, eruption of new acne lesions, healing of old lesions has also been observed.

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Saline Injection Therapy in Atrophic Acne Scars: A Clinical Trial in a Tertiary Care Hospital of Karachi
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: group on treatment

saline injection has been given intradermal in atrophic scars of acne on face.

Drug: saline injection therapy in post-acne atrophic scars
saline injection contains 0.9% isotonic sodium chloride solution
Other Names:
  • normal saline, isotonic saline
  • Outcome Measures

    Primary Outcome Measures

    1. change in morphology of scars [12 weeks]

      there is significant change in the morphology of scars, assessed by sharquie score for grading scars

    Secondary Outcome Measures

    1. change in dermatology life quality index of patients [12 weeks]

      significant change in dermatology life quality index of patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Minimum age 15years

    • Maximum age 35 years

    • Both males and females with mild, moderate and severe post-acne atrophic scars on face.

    Exclusion Criteria:
    • Hypertension

    • Cardiovascular disorders

    • Pregnancy

    • Lactation

    • Hypersensitivity to lidocaine.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jinnah postgraduate medical centre Karachi Sindh Pakistan 75510

    Sponsors and Collaborators

    • Jinnah Postgraduate Medical Centre

    Investigators

    • Study Director: Rabia Ghafoor, FCPS, jinnah postgraduate medical centre, karachi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidra Khan, Principal Investigator, Jinnah Postgraduate Medical Centre
    ClinicalTrials.gov Identifier:
    NCT04197245
    Other Study ID Numbers:
    • NO.F.2-81/2018-GENL/9008/JPMC
    First Posted:
    Dec 13, 2019
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sidra Khan, Principal Investigator, Jinnah Postgraduate Medical Centre
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2020