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Comparing the Efficacy of Topical Tazarotene Gel 0.1% v/s Microneedling in Atrophic Post Acne Scars

Primary Purpose

Acne Scar

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Tazarotene gel 0.1%
Microneedling
Sponsored by
Jinnah Postgraduate Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scar focused on measuring Tazarotene

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Both genders.
  • Age from 18 to 40 years.
  • Atrophic post-acne scar patients with duration 4 to 8 years.
  • Informed consent will be obtained.
  • Patients with grade 2 to 4 facial atrophic post-acne scars as assessed by the Goodman and Baron qualitative global scarring grading system.

Exclusion Criteria:

  • Pregnant or lactating woman.
  • Patients having any allergy related to given drug.
  • History of keloidal tendency or hypertrophic scarring.
  • Those with active acne or acne marks such as red, black or brown macular marks.
  • Patients with a previous history of dermabrasion or laser resurfacing on the face.
  • Facial scar due to reasons other than acne, collagen vascular disease or bleeding disorder.
  • Patients with a treatment history of <4 weeks for topical retinoid and alpha/beta hydroxy acids, <3 months for microdermabrasion and <6 months for oral retinoids.

Sites / Locations

  • Jinnah Post graduate medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group on Treatment:Tazarotene Gel

Group on Treatment:Microneedling

Arm Description

In group A, patients were instructed to apply a thin film of tazarotene gel 0.1% over the affected area once daily in the evening by placing a pea-sized amount of gel in the palm of the hand and using tip of a finger to cover the entire half of the face. Patients who experienced facial dryness were allowed to use a moisturizing cream during the day on entire face but use of any other medication on the face was prohibited. Intervention - Tazarotene gel 0.1%

In group B, microneedling was performed with a standard dermaroller (192 needles of length 1.5 mm) by the same investigator, once per month for 6 months. A topical anesthetic mixture of lignocaine and prilocaine was applied over the face in a thick layer under occlusion 1 hour before the procedure. Microneedling was performed by rolling the dermaroller with uniform and firm pressure in 4 different directions (i.e, perpendicular and diagonal to each other) with to-and-fro motion up to 8 times (a total of 32 passes) or until the end point of uniform pinpoint bleeding was achieved. After treatment, the area was wetted with saline pads. The participants were instructed to follow strict photoprotective measures including the application of a broad-spectrum sunscreen with sun protection factor 30 over the entire face. Intervention - Microneedling via dermarolller

Outcomes

Primary Outcome Measures

Change in morphology of Acne Scars
There is a change in Acne Scars assessed by Goodman and Baron Qualitative Acne Scars Grading system

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
October 11, 2022
Sponsor
Jinnah Postgraduate Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05573425
Brief Title
Comparing the Efficacy of Topical Tazarotene Gel 0.1% v/s Microneedling in Atrophic Post Acne Scars
Official Title
Comparing the Efficacy of Topical Tazarotene Gel 0.1% Versus Microneedling in Atrophic Post Acne Scars
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2020 (Actual)
Primary Completion Date
February 21, 2021 (Actual)
Study Completion Date
February 21, 2021 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to compare the Efficacy of Topical Tazarotene gel 0.1% versus Microneedling in atrophic Post acne scars. All patients of age 18-40 years, with grade 2 to grade 4 facial atrophic acne scars, assessed using the Goodman and Baron qualitative global scarring grading. Group A was given daily home application of Topical Tazarotene gel 0.1% while on Group B, Microneedling monthly sessions done for 12 weeks. The results were assessed by photographs, Goodman and Baron Qualitative Acne Scars Grading system at the start and end of treatment. SPSS 21 was used for data analysis which showed comparable efficacy of daily home based application of Topical Tazarotene gel 0.1% versus Microneedling monthly sessions in Atrophic Post Acne Scars.
Detailed Description
This was a randomized Control Trial, done in Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi from August 22, 2020 to February 21, 2021. A total of 202 patients with 101 in each group. The sample size was estimated using WHO sample size calculator using statistics for efficacy in topical Tazarotene gel (group A) as 30.5% and micro-needling (group B) as 47.2%,80% power of test and 95% confidence level. Both genders, 18 to 40 years with atrophic post-acne scar patients of duration 4 to 8 years were included. Informed consent was obtained. Patients with grade 2 to 4 facial atrophic post-acne scars assessed by Goodman and Baron qualitative global scarring grading system. While excluded pregnant/lactating woman, any prior allergy to given drug, history of keloidal tendency/hypertrophic scarring, active acne or acne marks such as red, black or brown macular marks, previous dermabrasion, laser resurfacing on face, facial scar due to reasons other than acne, collagen vascular disease, bleeding disorders, treatment history of <4 weeks for topical retinoid, alpha/beta hydroxyl acids, <3 months for microdermabrasion and <6 months for oral retinoids. This study was conducted after approval from ethical review committee and CPSP. During the patient first visit, baseline photographs were captured with informed consent. Dermoscopic examinations of predominant scar type (such as icepick, rolling or boxcar) and the ssca severity assessed according to the Goodman and Baron qualitative acne scarring grading systems for every patient. All patients were randomly divided into two groups using computer-generated sequential number placed in sealed envelopes and opened only before the commencement of the study. In group A, patients were instructed to apply a thin film of tazarotene gel 0.1% over the affected area once daily in the evening by placing a pea-sized amount of gel in the palm of the hand and using tip of a finger to cover the entire half of the face. Patients who experienced facial dryness were allowed to use a moisturizing cream during the day on entire face but use of any other medication on the face was prohibited. In group B, microneedling was performed with a standard dermaroller (192 needles of length 1.5 mm) by the same investigator, once per month for 6 months. A topical anesthetic mixture of lignocaine and prilocaine was applied over the face in a thick layer under occlusion 1 hour before the procedure. Microneedling was performed by rolling the dermaroller with uniform and firm pressure in 4 different directions (i.e, perpendicular and diagonal to each other) with to-and-fro motion up to 8 times (a total of 32 passes) or until the end point of uniform pinpoint bleeding was achieved. After treatment, the area was wetted with saline pads. The participants were instructed to follow strict photoprotective measures including the application of a broad-spectrum sunscreen with sun protection factor 30 over the entire face. All patients were followed up at 3 month and on 6 month from the baseline visit. Digital photographs were captured at 3 and 6 month follow-up visits. An improvement by 2 qualitative grades was considered excellent, by 1 grade was rated good, and by 0 grade was labeled a poor response. The outcome was the change from baseline in acne scar severity grade at 3 and 6 month follow-up visits. All the data was entered in a predesigned proforma. Biasness and confounder were controlled by strictly following the inclusion criteria. SPSS version 21 was used for data compilation and analysis. Frequencies and percentages were computed for qualitative variables like gender, scar type, treatment, scar severity grade at baseline, after 3 and 6 months and efficacy. Quantitative variables were presented as mean ± SD like age and duration of acne. Comparison between both groups for efficacy was done by using Chi square test. Effect modifier like age, gender and duration of disease were controlled through stratification. Post stratification, Chi square test was applied for categorical variables. Consider P <0.05 as significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scar
Keywords
Tazarotene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group on Treatment:Tazarotene Gel
Arm Type
Active Comparator
Arm Description
In group A, patients were instructed to apply a thin film of tazarotene gel 0.1% over the affected area once daily in the evening by placing a pea-sized amount of gel in the palm of the hand and using tip of a finger to cover the entire half of the face. Patients who experienced facial dryness were allowed to use a moisturizing cream during the day on entire face but use of any other medication on the face was prohibited. Intervention - Tazarotene gel 0.1%
Arm Title
Group on Treatment:Microneedling
Arm Type
Active Comparator
Arm Description
In group B, microneedling was performed with a standard dermaroller (192 needles of length 1.5 mm) by the same investigator, once per month for 6 months. A topical anesthetic mixture of lignocaine and prilocaine was applied over the face in a thick layer under occlusion 1 hour before the procedure. Microneedling was performed by rolling the dermaroller with uniform and firm pressure in 4 different directions (i.e, perpendicular and diagonal to each other) with to-and-fro motion up to 8 times (a total of 32 passes) or until the end point of uniform pinpoint bleeding was achieved. After treatment, the area was wetted with saline pads. The participants were instructed to follow strict photoprotective measures including the application of a broad-spectrum sunscreen with sun protection factor 30 over the entire face. Intervention - Microneedling via dermarolller
Intervention Type
Drug
Intervention Name(s)
Tazarotene gel 0.1%
Other Intervention Name(s)
Tazret gel 0.1%
Intervention Description
Tazarotene gel 0.1% applied daily on Acne Scars.
Intervention Type
Device
Intervention Name(s)
Microneedling
Other Intervention Name(s)
Dermaroller device
Intervention Description
Microneedling via dermaroller device performed on Acne Scars monthly.
Primary Outcome Measure Information:
Title
Change in morphology of Acne Scars
Description
There is a change in Acne Scars assessed by Goodman and Baron Qualitative Acne Scars Grading system
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both genders. Age from 18 to 40 years. Atrophic post-acne scar patients with duration 4 to 8 years. Informed consent will be obtained. Patients with grade 2 to 4 facial atrophic post-acne scars as assessed by the Goodman and Baron qualitative global scarring grading system. Exclusion Criteria: Pregnant or lactating woman. Patients having any allergy related to given drug. History of keloidal tendency or hypertrophic scarring. Those with active acne or acne marks such as red, black or brown macular marks. Patients with a previous history of dermabrasion or laser resurfacing on the face. Facial scar due to reasons other than acne, collagen vascular disease or bleeding disorder. Patients with a treatment history of <4 weeks for topical retinoid and alpha/beta hydroxy acids, <3 months for microdermabrasion and <6 months for oral retinoids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ghafoor
Organizational Affiliation
Jinnah Postgraduate Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Jinnah Post graduate medical center
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing the Efficacy of Topical Tazarotene Gel 0.1% v/s Microneedling in Atrophic Post Acne Scars

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