Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04197245
Study type Interventional
Source Jinnah Postgraduate Medical Centre
Contact
Status Completed
Phase Early Phase 1
Start date January 1, 2019
Completion date July 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT04806594 - Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar. N/A
Completed NCT01700595 - Preexpanded Perforator Flaps in Children N/A
Recruiting NCT03782038 - Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars N/A
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Not yet recruiting NCT02590042 - Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction Phase 1
Completed NCT01932359 - Rapidly Absorbable Versus Non-absorbable Sutures for Mohs Surgery Repair on the Face: a Randomized Controlled Split-scar Study N/A
Completed NCT01091181 - The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar N/A
Unknown status NCT00969475 - The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure N/A
Recruiting NCT06021275 - Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars N/A
Recruiting NCT02195063 - Survey Study for Pain Management, Wound Care, Scar Care or UDT Phase 4
Terminated NCT00803140 - Cutaneous Scarring of Scalpel Versus Cautery N/A
Not yet recruiting NCT04593706 - Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) N/A
Recruiting NCT05847530 - Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions N/A
Withdrawn NCT01350739 - The Umbilical Access in Laparoscopic Surgery N/A
Completed NCT02145130 - Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects Phase 1
Completed NCT01358838 - Ablative 10600 nm Fractional Laser Therapy for the Treatment of Scars N/A
Completed NCT03880058 - Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance Phase 1/Phase 2
Recruiting NCT05528328 - Post-surgical Scars After the Use of CACIPLIQ20 Phase 3
Completed NCT00450775 - Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars Phase 4
Completed NCT00580736 - Optical Clearing of the Skin in Conjunction With Laser Treatments Phase 1