Atrophic Acne ScarPhase 2NCT06789874
To Compare the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars
A Phase 2 study testing Intralesional Saline and 35% trichloracetic acid peel in people with Atrophic Acne Scar and Atrophic Acne Scarring, run by Sheikh Zayed Medical College at 2 sites in Pakistan.
Trial summary
This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Atrophic Acne Scar, Atrophic Acne Scarring
- What is being tested?
- Intralesional Saline and 35% trichloracetic acid peel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Apr 2023to 31 Oct 2023
- Phase
- Phase 2
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 13-50 years
- Clinically diagnosed patients of atrophic acne scars on face
- duration of more than 6 months
- no history of any procedural intervention in past 3 months
Who cannot join
- history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities
- history of use of oral isotretinoin, OCPs, steroids or immunosuppressants
- pregnant or lactating females
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Sheikh Zayed Medical College/Hospital
Rahimyarkhan, Punjab Province, 62400
Sheikh Zayed Medical College/Hospital
Rahimyarkhan, Punjab Province, 644200
About this study
Official title: Comparing the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars
This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.
Read the detailed description
Acne vulgaris is a common skin problem affecting adolescents and adults. It is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.A randomized controlled trial was conducted at the Dermatology Department, Sheikh Zayed Hospital, Rahim Yar Khan, from 1st April 2023 to 31st October 2023. 126 patients were enrolled. Scar grading was based on Goodman and Baron's Qualitative Scar Classification. The Observer Scar Assessment Scale (OSAS) was used by dermatologists. Patients rated their acne scars using the Visual Disease Severity Scale. Photographs were taken for comparison. Efficacy was defined as ≥50% improvement in the OSAS.
- Conditions
- Atrophic Acne Scar, Atrophic Acne Scarring
- Being tested
- Intralesional Saline, 35% trichloracetic acid peel
- Keywords
- Acne scars, TCA peel, Intralesional saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional SalineProcedure or surgery
Intralesional Saline injected in scars
35% trichloracetic acid peelProcedure or surgery
35%Trichloracetic acid peel was applied to scars monthly for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Saline for acne scars (Group A) | Active comparator | Intralesional Saline 5 to 10ml injected in the sacrs fortnightly for 3 months Receives: Procedure: Intralesional Saline |
| Topical Trichloracetic acid for acne scars(Group B) | Active comparator | 35% trichloroacetic acid peel was applied to scars monthly for 3 months Receives: Procedure: 35% trichloracetic acid peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observer Scar Assessment Scale
efficacy was labelled as improvement on observer scar assessment scale by >50% compared to baseline. Patient's satisfaction was recorded as 'not satisfied' (VAS score of 1-5), 'Satisfied' (VAS score of 6-7), and 'very satisfied' (Vas score of 8-10)
Measured: clinical assessment will be done monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Apr 2023
- Primary completion30 Jun 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Acne ScarStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789874
- Sponsor's protocol ID
- Sheikhzayedmedicalcollege SZMC
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT06789874
- Acronym / sponsor ID
- Sheikhzayedmedicalcollege SZMC
- Conditions
- Atrophic Acne Scar, Atrophic Acne Scarring
- Keywords
- Acne scars, TCA peel, Intralesional saline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Jan 2025 (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.
This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.
Detailed description
Acne vulgaris is a common skin problem affecting adolescents and adults. It is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.A randomized controlled trial was conducted at the Dermatology Department, Sheikh Zayed Hospital, Rahim Yar Khan, from 1st April 2023 to 31st October 2023. 126 patients were enrolled. Scar grading was based on Goodman and Baron's Qualitative Scar Classification. The Observer Scar Assessment Scale (OSAS) was used by dermatologists. Patients rated their acne scars using the Visual Disease Severity Scale. Photographs were taken for comparison. Efficacy was defined as ≥50% improvement in the OSAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Saline for acne scars (Group A) | Active comparator | Procedure: Intralesional SalineIntralesional Saline 5 to 10ml injected in the sacrs fortnightly for 3 months |
| Topical Trichloracetic acid for acne scars(Group B) | Active comparator | Procedure: 35% trichloracetic acid peel35% trichloroacetic acid peel was applied to scars monthly for 3 months |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 13-50 years
- Clinically diagnosed patients of atrophic acne scars on face
- duration of more than 6 months
- no history of any procedural intervention in past 3 months
Key exclusion criteria (3 listed)
- history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities
- history of use of oral isotretinoin, OCPs, steroids or immunosuppressants
- pregnant or lactating females
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 |
|---|---|---|
| Intralesional SalineIntralesional Saline injected in scars | Procedure or surgery | Intralesional Saline for acne scars (Group A) |
| 35% trichloracetic acid peel35%Trichloracetic acid peel was applied to scars monthly for 3 months | Procedure or surgery | Topical Trichloracetic acid for acne scars(Group B) |
Primary outcome
Observer Scar Assessment Scale
Time frame: clinical assessment will be done monthly for 6 months
efficacy was labelled as improvement on observer scar assessment scale by >50% compared to baseline. Patient's satisfaction was recorded as 'not satisfied' (VAS score of 1-5), 'Satisfied' (VAS score of 6-7), and 'very satisfied' (Vas score of 8-10)
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 23 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intralesional Saline and 35% trichloracetic acid peel in people with Atrophic Acne Scar and Atrophic Acne Scarring, run by Sheikh Zayed Medical College at 2 sites 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 4 inclusion and 3 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Observer Scar Assessment Scale (time frame: clinical assessment will be done monthly for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2025.