NCT03170596

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

Completed NA Last updated 4 April 2018

What this trial tests

NA trial testing tazarotene gel 0.1% in Atrophic Post Acne Scarring in 36 participants. Completed in 29 March 2018.

Timeline

2 June 2017

Primary endpoint
28 February 2018

29 March 2018

Quick facts

Lead sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	36
Start date	2 June 2017
Primary completion	28 February 2018
Estimated completion	29 March 2018
Sites	1 location across India

Drugs / interventions tested

• tazarotene gel 0.1%
• Microneedling

Conditions studied

• Atrophic Post Acne Scarring — all drugs for Atrophic Post Acne Scarring →

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Who can join

18 and older, any sex, with Atrophic Post Acne Scarring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Topical Tazarotene Gel, 0.1%, as a Novel Treatment Approach for Atrophic Postacne Scars: A Randomized Active-Controlled Clinical Trial.
   Afra TP, Razmi T M, Narang T, Dogra S, et al · · 2019 · cited 19× · PMID 30452511 · DOI 10.1001/jamafacial.2018.1404
2. Recommendations to Improve Outcomes in Acne and Acne Sequelae: A Focus on Trifarotene and Other Retinoids.
   Issa N, Alexis A, Baldwin H, Hamzavi I, et al · · 2025 · cited 2× · PMID 39984798 · DOI 10.1007/s13555-025-01344-y