ATROPHIC ACNE SCARSPhase 2NCT06002854
Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.
A Phase 2 study testing PRP( platelet rich plasma) and Insulin human in people with ATROPHIC ACNE SCARS, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
Microneedling with topical INSULIN is a simple, effective tool for building body's new collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The skin responds to fine punctures with the release of growth factors. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ATROPHIC ACNE SCARS
- What is being tested?
- PRP( platelet rich plasma) and Insulin human
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 1 Feb 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system
- Either gender.
- Age 20-50 years.
Who cannot join
- lactation and pregnancy
- skin cancers and infection
- photosensitivity like SLE ,XP
- use of RETINOIDS in last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Outcome Of Treatment of Microneedling With Autologous Platelet- Rich -Plasma Versus Microneedling With Topical Insulin In The Treatment Of Post Acne Atrophic Scars.
Microneedling with topical INSULIN is a simple, effective tool for building body's new collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure that can be performed in the office without complications, with a good cost-benefit because it is economically viable without any effect on patient's daily activities. 9
- Conditions
- ATROPHIC ACNE SCARS
- Being tested
- PRP( platelet rich plasma) and Insulin human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP( platelet rich plasma) and Insulin humanDrug
Microneedling with autologus PRP reduces inflammationin acne scars. Insulin human is a new topical drug which is used nowadays for acne scars as it is more effective in producing collagen formation as well as new blood vessel formation
| Study group | Role | What they receive |
|---|---|---|
| GROUP A Microneedling with PRP(platelete rich plasma) | Experimental | Not described Receives: Drug: PRP( platelet rich plasma) and Insulin human |
| GROUP B Microneedling with topical INSULIN | Experimental | Not described Receives: Drug: PRP( platelet rich plasma) and Insulin human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars
Efficacy will be assessed by using Goodman and Baron Qualitative Scar Grading System
Measured: Efficacy will be assesed upto 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Aug 2022
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATROPHIC ACNE SCARSStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nazia Jabeen, Jinnah Postgraduate Medical Centre
- Investigators
- KHADIJA ASADULLAH, MBBS, Principal investigator, JPMCFAIZA INAM, FCPS, Principal investigator, JPMCPARISA SANAWAR, FCPS, Principal investigator, JPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002854
- Sponsor's protocol ID
- NO.F.2-81/2022-GENL/252/JPMC
- Status last verified
- Jun 2023
- First submitted
- 25 Mar 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Outcome Of Treatment of Microneedling With Autologous Platelet- Rich -Plasma Versus Microneedling With Topical Insulin In The Treatment Of Post Acne Atrophic Scars.
- ClinicalTrials.gov ID
- NCT06002854
- Acronym / sponsor ID
- NO.F.2-81/2022-GENL/252/JPMC
- Conditions
- ATROPHIC ACNE SCARS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Aug 2023 (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.
Microneedling with topical INSULIN is a simple, effective tool for building body's new collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure that can be performed in the office without complications, with a good cost-benefit because it is economically viable without any effect on patient's daily activities. 9
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A Microneedling with PRP(platelete rich plasma) | Experimental | Drug: PRP( platelet rich plasma) and Insulin human |
| GROUP B Microneedling with topical INSULIN | Experimental | Drug: PRP( platelet rich plasma) and Insulin human |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system
- Either gender.
- Age 20-50 years.
Key exclusion criteria (4 listed)
- lactation and pregnancy
- skin cancers and infection
- photosensitivity like SLE ,XP
- use of RETINOIDS in last 6 months.
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 |
|---|---|---|
| PRP( platelet rich plasma) and Insulin humanMicroneedling with autologus PRP reduces inflammationin acne scars. Insulin human is a new topical drug which is used nowadays for acne scars as it is more effective in producing collagen formation as well as new blood vessel formation | Drug | GROUP A Microneedling with PRP(platelete rich plasma), GROUP B Microneedling with topical INSULIN |
Primary outcome
Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars
Time frame: Efficacy will be assesed upto 4 months.
Efficacy will be assessed by using Goodman and Baron Qualitative Scar Grading System
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 21 Aug 2023.
Related trials for ATROPHIC ACNE SCARS
Recruiting
Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Acne Scars
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
Poly-L-Lactic Acid in Atrophic Acne Scars
Atrophic Acne Scarring
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic
Not yet recruiting
Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
Acne Scars, Acne Scars - Atrophic
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.
KHADIJA ASADULLAH, MBBS principal investigator
JPMC
FAIZA INAM, FCPS principal investigator
JPMC
PARISA SANAWAR, FCPS principal investigator
JPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP( platelet rich plasma) and Insulin human in people with ATROPHIC ACNE 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 4 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 21 Aug 2023. 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?
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?
Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars (time frame: Efficacy will be assesed upto 4 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 21 Aug 2023.