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

NCT ID: NCT03170596

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2018-03-29

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.

Conditions

Atrophic Post Acne Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tazarotene gel arm

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

Group Type: EXPERIMENTAL

tazarotene gel 0.1%

Intervention Type: DRUG

Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening.

Microneedling arm

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

Group Type: ACTIVE_COMPARATOR

Microneedling

Intervention Type: DEVICE

Microneedling is a method of percutaneous collagen induction

Interventions

tazarotene gel 0.1%

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: DRUG

Microneedling

Microneedling is a method of percutaneous collagen induction

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Tarun Narang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarun Narang, MD

Role: STUDY_CHAIR

Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India

Locations

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

Chandigarh, , India

Countries

India

References

Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529.

Reference Type: BACKGROUND

PMID: 20808602 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12095066 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12437455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17199653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30452511 (View on PubMed)

Other Identifiers

NK/3486/MD

Identifier Type: -

Identifier Source: org_study_id