Efficacy of Saline Injection Therapy in Atrophic Acne Scars
Primary Purpose
Atrophic, Scars
Status
Completed
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
saline injection therapy in post-acne atrophic scars
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic focused on measuring Acne, Scars, DLQI
Eligibility Criteria
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.
Sites / Locations
- Jinnah postgraduate medical centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group on treatment
Arm Description
saline injection has been given intradermal in atrophic scars of acne on face.
Outcomes
Primary Outcome Measures
change in morphology of scars
there is significant change in the morphology of scars, assessed by sharquie score for grading scars
Secondary Outcome Measures
change in dermatology life quality index of patients
significant change in dermatology life quality index of patients
Full Information
NCT ID
NCT04197245
First Posted
December 6, 2019
Last Updated
January 26, 2020
Sponsor
Jinnah Postgraduate Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT04197245
Brief Title
Efficacy of Saline Injection Therapy in Atrophic Acne Scars
Official Title
Efficacy of Saline Injection Therapy in Atrophic Acne Scars: A Clinical Trial in a Tertiary Care Hospital of Karachi
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic, Scars
Keywords
Acne, Scars, DLQI
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group on treatment
Arm Type
Experimental
Arm Description
saline injection has been given intradermal in atrophic scars of acne on face.
Intervention Type
Drug
Intervention Name(s)
saline injection therapy in post-acne atrophic scars
Other Intervention Name(s)
normal saline, isotonic saline
Intervention Description
saline injection contains 0.9% isotonic sodium chloride solution
Primary Outcome Measure Information:
Title
change in morphology of scars
Description
there is significant change in the morphology of scars, assessed by sharquie score for grading scars
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change in dermatology life quality index of patients
Description
significant change in dermatology life quality index of patients
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ghafoor, FCPS
Organizational Affiliation
jinnah postgraduate medical centre, karachi
Official's Role
Study Director
Facility Information:
Facility Name
Jinnah postgraduate medical centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25588037
Citation
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.
Results Reference
result
Citation
Bagherani, N, Smoller, B. Introduction of a novel therapeutic option for atrophic acne scars: saline injection therapy. Global dermatology. 2015;2(6): 225-7
Results Reference
result
PubMed Identifier
27688440
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy of Saline Injection Therapy in Atrophic Acne Scars
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