NCT06002854

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

March 25, 2023

Last Update Submit

August 18, 2023

Conditions

ATROPHIC ACNE SCARS

Outcome Measures

Primary Outcomes (1)

  • 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

    Efficacy will be assesed upto 4 months.

Study Arms (2)

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

Interventions

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

GROUP A Microneedling with PRP(platelete rich plasma)GROUP B Microneedling with topical INSULIN

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system
  • Either gender.
  • Age 20-50 years.

You may not qualify if:

  • lactation and pregnancy
  • skin cancers and infection
  • photosensitivity like SLE ,XP
  • use of RETINOIDS in last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JPMC

Karachi, Sindh, Pakistan

Location

Study Officials

  • KHADIJA ASADULLAH, MBBS

    JPMC

    PRINCIPAL INVESTIGATOR

  • FAIZA INAM, FCPS

    JPMC

    PRINCIPAL INVESTIGATOR

  • PARISA SANAWAR, FCPS

    JPMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2023

First Posted

August 21, 2023

Study Start

August 1, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

August 21, 2023

Record last verified: 2023-06

Locations

PA(1)