Efficacy of Saline Injection Therapy in Atrophic Acne Scars
NCT ID: NCT04197245
Last Updated: 2020-01-28
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
49 participants
INTERVENTIONAL
2019-01-01
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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group on treatment
saline injection has been given intradermal in atrophic scars of acne on face.
saline injection therapy in post-acne atrophic scars
saline injection contains 0.9% isotonic sodium chloride solution
Interventions
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saline injection therapy in post-acne atrophic scars
saline injection contains 0.9% isotonic sodium chloride solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maximum age 35 years
* Both males and females with mild, moderate and severe post-acne atrophic scars on face.
Exclusion Criteria
* Cardiovascular disorders
* Pregnancy
* Lactation
* Hypersensitivity to lidocaine.
15 Years
35 Years
ALL
Yes
Sponsors
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Jinnah Postgraduate Medical Centre
OTHER_GOV
Responsible Party
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Sidra Khan
Principal Investigator
Principal Investigators
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Rabia Ghafoor, FCPS
Role: STUDY_DIRECTOR
jinnah postgraduate medical centre, karachi
Locations
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Jinnah postgraduate medical centre
Karachi, Sindh, Pakistan
Countries
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References
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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.
Other Identifiers
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NO.F.2-81/2018-GENL/9008/JPMC
Identifier Type: -
Identifier Source: org_study_id
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