Efficacy of Saline Injection Therapy in Atrophic Acne Scars

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

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.

Study Overview

• Status: Completed
• Conditions: Scars; Atrophic
• Intervention / Treatment: Drug: saline injection therapy in post-acne atrophic scars

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Jinnah Postgraduate Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 33 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre
• Investigators: Study Director: Rabia Ghafoor, FCPS, jinnah postgraduate medical centre, karachi

Publications and helpful links

General Publications

• Al-Dhalimi M, Jaber A. Treatment of atrophic facial acne scars with fractional Er:Yag laser. J Cosmet Laser Ther. 2015;17(4):184-8. doi: 10.3109/14764172.2015.1007067. Epub 2015 Feb 13.
• Bagherani, N, Smoller, B. Introduction of a novel therapeutic option for atrophic acne scars: saline injection therapy. Global dermatology. 2015;2(6): 225-7
• Hazarika N, Archana M. The Psychosocial Impact of Acne Vulgaris. Indian J Dermatol. 2016 Sep-Oct;61(5):515-20. doi: 10.4103/0019-5154.190102.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Acne; Scars; DLQI
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: NO.F.2-81/2018-GENL/9008/JPMC

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