Efficacy of Saline Injection Therapy in Atrophic Acne Scars

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Saline Injection Therapy in Atrophic Acne Scars: A Clinical Trial in a Tertiary Care Hospital of Karachi

Conditions
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Atrophic, Scars

Intervention / Treatment
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* Drug: saline injection therapy in post-acne atrophic scars


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group on treatment<br>saline injection has been given intradermal in atrophic scars of acne on face. | Drug: saline injection therapy in post-acne atrophic scars<br>* saline injection contains 0.9% isotonic sodium chloride solution<br>* Other names: normal saline, isotonic saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in morphology of scars | there is significant change in the morphology of scars, assessed by sharquie score for grading scars | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in dermatology life quality index of patients | significant change in dermatology life quality index of patients | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Scars, DLQI