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Comparison Between Microneedling Daycare Procedure and Tazarotene 0.1% Gel Local Application in Acne Scarring

Primary Purpose

Atrophic Post Acne Scarring

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
tazarotene gel 0.1%
Microneedling
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Post Acne Scarring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with grade 2 to grade 4 atrophic acne scars, classified on the basis of Goodman's Qualitative classification.6
  • Should not have undergone any surgical and/or laser treatment for acne scars in the past 1 year.

Exclusion Criteria:

  • Active acne
  • History of keloidal tendency/hypertrophic or keloidal scarring on the face due to acne
  • Facial scars due to reasons other than acne like varicella, trauma, burns etc
  • Collagen vascular disease, bleeding disorders
  • Any active bacterial , fungal or viral infection over face
  • Pregnant and lactating females
  • Known hypersensitivity to tazarotene
  • Age less than 18 years
  • Patients on anticoagulant therapy or aspirin

Sites / Locations

  • Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tazarotene gel arm

Microneedling arm

Arm Description

The treatment protocol in this arm will consist of night time application of Tazarotene 0.1% gel during the entire study period. (3 months)

The treatment protocol in this arm will consist of four sessions of microneedling at monthly intervals. (0, 1, 2, 3 months)

Outcomes

Primary Outcome Measures

Acne scar severity grade at final visit
Change in acne scar severity grade from baseline and at 6 months

Secondary Outcome Measures

Acne scar severity grade at final visit at 3 months
Change in acne scar severity grade from baseline and at 3 months
Patient satisfaction
Patient satisfaction using Patient's global assessment score done at 6 months
Adverse events
Adverse events noted in both arms during the study period of 6 months

Full Information

First Posted
May 26, 2017
Last Updated
April 3, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03170596
Brief Title
Comparison Between Microneedling Daycare Procedure and Tazarotene 0.1% Gel Local Application in Acne Scarring
Official Title
Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Post acne scarring is a common complication of acne. Cosmetic appearance of the post acne facial scarring can be improved by various methods. Among the procedural methods microneedling (1) is a novel and a promising option. It is a minimally invasive day care procedure for the management of atrophic acne scars. Topical tazarotene 0.1% gel is an effective medical method in the management of acne vulgaris and macular acne scars (2, 3). Based on its mechanism of action and role in collagen synthesis, topical tazarotene is a logical choice to investigate for the management of atrophic post acne scars. This is a pilot study comparing microneedling and topical tazarotene for the treatment of atrophic post acne scarring in regard to extent and rapidity of improvement, patient satisfaction and any adverse events if any. Thirty six subjects with grade 2 to grade 4 atrophic post acne scars, classified on the basis of Goodman's Qualitative classification (4) criteria will be recruited. Goodman's qualitative and quantitative acne scarring grading system scoring will be performed for the assessment of severity of acne scarring at baseline. The face of each patient will be randomized for monthly microneedling on one side and topical tazarotene 0.1 % gel once a day local application on opposite side, using computer generated random number table. Follow ups will be done at every month until treatment completion (3 months) and 3 months after the last treatment session. Goodman's qualitative and quantitative acne scarring grading system scoring will be performed at 3rd and 6th month follow up visits. An improvement by two grades will be considered as excellent, one grade will be rated as good and no up gradation will be labelled as poor response. Patients will be also assessed by a blinded observer for clinical improvement and scored on a scale of 0 (no improvement) to 10 (maximum) at 3rd and 6th month follow up visits with the help of serial photographs taken under consistent background, position and lighting. All patients will be instructed to assess themselves using Patients' Global Assessment Score 0 (no response) to 10 (maximum) at 3rd and 6th month follow up visits. The investigators hope the outcome of the present study may propose a newer medical modality for acne scarring, i.e topical tazarotene 0.1% gel, which can be used at home, obviating the need for physician dependant microneedling procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Post Acne Scarring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Microneedling procedure will be done on one half of the face and patients will be instructed to apply tazarotene 0.1% gel on the other half of the face
Masking
Outcomes Assessor
Masking Description
An independant senior dermatologist who is blinded regarding the modality used for atrophic acne scarring in each half of the face, will be assessing the outcome scores.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tazarotene gel arm
Arm Type
Experimental
Arm Description
The treatment protocol in this arm will consist of night time application of Tazarotene 0.1% gel during the entire study period. (3 months)
Arm Title
Microneedling arm
Arm Type
Active Comparator
Arm Description
The treatment protocol in this arm will consist of four sessions of microneedling at monthly intervals. (0, 1, 2, 3 months)
Intervention Type
Drug
Intervention Name(s)
tazarotene gel 0.1%
Intervention Description
Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening.
Intervention Type
Device
Intervention Name(s)
Microneedling
Intervention Description
Microneedling is a method of percutaneous collagen induction
Primary Outcome Measure Information:
Title
Acne scar severity grade at final visit
Description
Change in acne scar severity grade from baseline and at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Acne scar severity grade at final visit at 3 months
Description
Change in acne scar severity grade from baseline and at 3 months
Time Frame
3 months
Title
Patient satisfaction
Description
Patient satisfaction using Patient's global assessment score done at 6 months
Time Frame
6 months
Title
Adverse events
Description
Adverse events noted in both arms during the study period of 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with grade 2 to grade 4 atrophic acne scars, classified on the basis of Goodman's Qualitative classification.6 Should not have undergone any surgical and/or laser treatment for acne scars in the past 1 year. Exclusion Criteria: Active acne History of keloidal tendency/hypertrophic or keloidal scarring on the face due to acne Facial scars due to reasons other than acne like varicella, trauma, burns etc Collagen vascular disease, bleeding disorders Any active bacterial , fungal or viral infection over face Pregnant and lactating females Known hypersensitivity to tazarotene Age less than 18 years Patients on anticoagulant therapy or aspirin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarun Narang, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
Official's Role
Study Chair
Facility Information:
Facility Name
Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20808602
Citation
Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529.
Results Reference
background
PubMed Identifier
12095066
Citation
Webster GF, Guenther L, Poulin YP, Solomon BA, Loven K, Lee J. A multicenter, double-blind, randomized comparison study of the efficacy and tolerability of once-daily tazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acne vulgaris. Cutis. 2002 Feb;69(2 Suppl):4-11.
Results Reference
background
PubMed Identifier
12437455
Citation
Phillips TJ, Gottlieb AB, Leyden JJ, Lowe NJ, Lew-Kaya DA, Sefton J, Walker PS, Gibson JR; Tazarotene Cream Photodamage Clinical Study Group. Efficacy of 0.1% tazarotene cream for the treatment of photodamage: a 12-month multicenter, randomized trial. Arch Dermatol. 2002 Nov;138(11):1486-93. doi: 10.1001/archderm.138.11.1486.
Results Reference
background
PubMed Identifier
17199653
Citation
Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.
Results Reference
background
PubMed Identifier
30452511
Citation
Afra TP, Razmi T M, Narang T, Dogra S, Kumar A. Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial. JAMA Facial Plast Surg. 2019 Mar 1;21(2):125-132. doi: 10.1001/jamafacial.2018.1404.
Results Reference
derived

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Comparison Between Microneedling Daycare Procedure and Tazarotene 0.1% Gel Local Application in Acne Scarring

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