Back to resultsComparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.
Primary Purpose
ATROPHIC ACNE SCARS
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
PRP( platelet rich plasma) and Insulin human
Sponsored by
About this trial
This is an interventional treatment trial for ATROPHIC ACNE SCARS
Eligibility Criteria
Inclusion Criteria: postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system Either gender. Age 20-50 years. Exclusion Criteria: lactation and pregnancy skin cancers and infection photosensitivity like SLE ,XP use of RETINOIDS in last 6 months.
Sites / Locations
- JPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GROUP A Microneedling with PRP(platelete rich plasma)
GROUP B Microneedling with topical INSULIN
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06002854
First Posted
March 25, 2023
Last Updated
August 18, 2023
Sponsor
Jinnah Postgraduate Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT06002854
Brief Title
Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
February 1, 2023 (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
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ATROPHIC ACNE SCARS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP A Microneedling with PRP(platelete rich plasma)
Arm Type
Experimental
Arm Title
GROUP B Microneedling with topical INSULIN
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRP( platelet rich plasma) and Insulin human
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars
Description
Efficacy will be assessed by using Goodman and Baron Qualitative Scar Grading System
Time Frame
Efficacy will be assesed upto 4 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system
Either gender.
Age 20-50 years.
Exclusion Criteria:
lactation and pregnancy
skin cancers and infection
photosensitivity like SLE ,XP
use of RETINOIDS in last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KHADIJA ASADULLAH, MBBS
Organizational Affiliation
JPMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FAIZA INAM, FCPS
Organizational Affiliation
JPMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PARISA SANAWAR, FCPS
Organizational Affiliation
JPMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
JPMC
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.
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