AtrophicEarly Phase 1NCT04197245
Efficacy of Saline Injection Therapy in Atrophic Acne Scars
A Early Phase 1 study testing saline injection therapy in post-acne atrophic scars in people with Atrophic and Scars, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- What is being tested?
- saline injection therapy in post-acne atrophic scars
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 31 Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Minimum age 15years
- Maximum age 35 years
- Both males and females with mild, moderate and severe post-acne atrophic scars on face.
Who cannot join
- Hypertension
- Cardiovascular disorders
- Pregnancy
- Lactation
- Hypersensitivity to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- saline injection therapy in post-acne atrophic scars
- Keywords
- Acne, Scars, DLQI
- Medical subject headings
- Atrophy, Cicatrix, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline injection therapy in post-acne atrophic scarsDrug
Also called normal saline, isotonic saline
saline injection contains 0.9% isotonic sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| group on treatment | Experimental | saline injection has been given intradermal in atrophic scars of acne on face. Receives: Drug: saline injection therapy in post-acne atrophic scars |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in morphology of scars
there is significant change in the morphology of scars, assessed by sharquie score for grading scars
Measured: 12 weeks
Secondary outcomes (1)
change in dermatology life quality index of patients
significant change in dermatology life quality index of patients
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtrophicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sidra Khan, Jinnah Postgraduate Medical Centre
- Investigators
- Rabia Ghafoor, FCPS, Study director, jinnah postgraduate medical centre, karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197245
- Sponsor's protocol ID
- NO.F.2-81/2018-GENL/9008/JPMC
- Status last verified
- Jan 2020
- First submitted
- 6 Dec 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25588037Bagherani, 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.
PubMed 27688440
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Saline Injection Therapy in Atrophic Acne Scars: A Clinical Trial in a Tertiary Care Hospital of Karachi
- ClinicalTrials.gov ID
- NCT04197245
- Acronym / sponsor ID
- NO.F.2-81/2018-GENL/9008/JPMC
- Keywords
- Acne, Scars, DLQI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group on treatment | Experimental | Drug: saline injection therapy in post-acne atrophic scarssaline injection has been given intradermal in atrophic scars of acne on face. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Minimum age 15years
- Maximum age 35 years
- Both males and females with mild, moderate and severe post-acne atrophic scars on face.
Key exclusion criteria (5 listed)
- Hypertension
- Cardiovascular disorders
- Pregnancy
- Lactation
- Hypersensitivity to lidocaine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saline injection therapy in post-acne atrophic scarsAlso: normal saline, isotonic salinesaline injection contains 0.9% isotonic sodium chloride solution | Drug | group on treatment |
Primary outcome
change in morphology of scars
Time frame: 12 weeks
there is significant change in the morphology of scars, assessed by sharquie score for grading scars
1 secondary outcome
change in dermatology life quality index of patients
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Results publication: PubMed 25588037Al-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 publicationBagherani, N, Smoller, B. Introduction of a novel therapeutic option for atrophic acne scars: saline injection therapy. Global dermatology. 2015;2(6): 225-7
- Results publication: PubMed 27688440Hazarika 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Ghafoor, FCPS study director
jinnah postgraduate medical centre, karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing saline injection therapy in post-acne atrophic scars in people with Atrophic and Scars, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in morphology of scars (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.